 | Medicinal Products |
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Indlaegsseddel.dk – your electronic package leaflet |
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Summaries of Product Characteristics (SPC) |
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Faster access to summaries of product characteristics online |
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Guidance for finding summaries of product characteristics for centrally authorised medicinal products |
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New links for summaries of product characteristics |
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Lists with information about medicinal products |
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List of distributors of medicinal products for production animals |
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Compassionate use permits |
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Compassionate use permit for experimental treatment with medicinal products |
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Warnings |
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Healthcare professionals to stay aware of mix-ups between solutions for infusion or irrigation |
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Warning against the product Prostasol with oestrogen |
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Warning: Counterfeit Cipralex® found in Egypt |
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Warning against the Malaysian product Libidus with the substance vardenafil |
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Warning: Illegal copy of the medicinal product Cialis® sold on the internet |
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Warning: Sale of illegal diet pills |
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Chinese products containing tadalafil, sildenafil and sibutramine |
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Preparations with wrong indication of constituents |
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Kamagra tablets with sildenafil |
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Heavy metals in products for traditional Indian healing |
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Warning on adverse reactions from Coleus Forskolii Briq |
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Warning: Illegal copies of medicinal products with the active substance rimonabant sold on the internet |
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Illegal anti-impotence drug sold via coupon leaflets |
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Warning: Counterfeit Xenical® sold via the internet |
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Withdrawal of Serevent® inhalation powder in Diskos® 50 microgram/dose |
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Warning: Counterfeit versions of the medicinal product Tertensif® found in Bulgaria |
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Warning: Unauthorised sale of donated sperm from the sperm bank A.I. Sædbank |
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Counterfeit versions of the medicinal products Plavix® and Casodex@ found in Great Britain |
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Counterfeit versions of the medicinal product Zyprexa® found in Great Britain |
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Warning: Illegal sibutramine-containing weight-loss products sold on the internet |
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Marketing of Trasylol® (aprotinin) temporarily suspended by Bayer Healthcare Pharmaceuticals |
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The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against the weight loss product Therma Power |
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Warning against the products Herb Vigour, China Vigour and Natural Vigour |
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Warning about Power 1 Walnut |
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Warning against vpxl N°1 Dietary Supplement for Men |
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Warning: Counterfeit packages of Cipralex® found in Pakistan |
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Warning against the product Wodibo |
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Warning against the product Melanotan |
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Warning about unauthorised distribution of donated sperm from the sperm bank A.I. Sædbank |
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Danish Medicines Agency warns against the weight-loss product Therma Power |
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Recall of Nobligan® oral drops in Denmark |
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Warning against the product Viamax Energizer |
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Withdrawal of the asthma and lung medicine Oxis Turbohaler® with batch no. IA763-3 |
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Warning on Hydroxycut pills |
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Beware of mix-ups between products containing mirtazapine and mianserin |
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Warning: Counterfeit Viagra® sold on Danish website |
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Warning against the weight-loss product Super Slim |
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Warning against the potency-enhancing product Rock Hard Weekend |
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Warning against counterfeit Alli® from the USA |
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Updated warning against counterfeit Alli® from the USA |
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Warning against pills from IDS Sports |
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Warning against ‘Alscreme Creme nr. 2’ from www.eminescu.dk |
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Focus on safe handling and use of pain-relief patches |
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Alscreme 'Creme nr. 2' – information for Danish physicians |
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Strengthened warning against Alscreme 'Creme nr. 2' from www.eminescu.dk |
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The Danish Medicines Agency warns against the use of silicone breast implants manufactured by Poly Implant Prothèse, France |
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EMA reassesses cardiovascular safety of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim) |
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Over-the-counter medicinal products |
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Changed basic range of over-the-counter medicinal products |
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Thresholds for the total amount of active substance in certain medicinal products sold in general sales outlets |
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More medicinal products sold in general sale outlets |
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OTC medicines and release for sale outside pharmacies |
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Herbal medicinal products etc. |
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Herbal medicinal products |
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Vitamins and mineral preparations |
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Radiopharmaceuticals |
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Compassionate use permits |
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Veterinary medicinal products |
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European cooperation on the replacement of animal testing with the PCR technique in the testing of veterinary vaccines |
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Testing for extraneous agents in veterinary immunological products |
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Veterinary premix and medicated feed |
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Quality monitoring of veterinary vaccines |
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Doping products |
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Consultative list of substances covered by section 1 of Act no. 232 of 21 April 1999 on prohibition of certain doping agents |
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Medicine containing narcotic drugs |
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Guidelines and forms |
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Fees on products containing narcotic drugs |
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Amendment of executive order on euphoriant substances |
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Amendment of Danish executive order on euphoriant substances |
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Fees on medicine containing narcotic drugs |
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Medicinal products affecting the ability to drive |
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List of medicinal products affecting the ability to drive |
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Publication of information on medicinal products |
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How to use the list of authorised medicinal products |
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How to use the list of deregistered medicinal products |
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Classification of electronic cigarettes |
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| Pharmacovigilance |
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Registration and monitoring of side effects |
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Information on adverse drug reactions |
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First adverse drug reaction report about Therma Power |
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Glucosamine - new information on effect on osteoarthritis |
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No significantly higher mortality due to use of clarithromycin |
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Clarithromycin for patients with ischemic heart disease |
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Adverse reactions reported from influenza vaccine |
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NSAID and pregnancy |
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The risk of cardiovascular adverse reactions from methylphenidate |
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Glucosamine and elevated cholesterol |
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Medicinal products containing erythromycin should be avoided in early pregnancy |
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Antidepressants and the risk of malformation – preliminary results |
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Study of adverse reactions from anaesthetics for dental treatment |
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Strengthened warnings on the use of COX-2 inhibitors |
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NSAID and risk of blood clots |
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European Medicines Agency recommends suspension of marketing authorisations for sibutramine due to increased risk of cardiovascular events |
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European strategy for safe medicinal products |
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The European strategy for risk management within the pharmaceutical area: Status and future initiatives |
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The abortion pill Mifegyne® tested for adverse reactions |
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New information on hormone replacement therapy and the risk of uterine cancer |
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Withdrawal of Co-proxamol from the English market |
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Risk in using the skin creams Elidel® and Protopic® for eczema |
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Questions and answers about the use of Vioxx® and other COX-2 inhibitor |
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One year with ADR consumer reports |
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Procedure for testing exchange of E2B files with the Danish Medicines Agency |
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The Danish Medicines Agency emphasises the warning about the use of the potency product Libidfit® |
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Uniform information about adverse reactions from NSAID |
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Cough medicines - do they work or not? |
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Seroxat® (paroxetine) and risk of congenital malformations |
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Discontinuation of a clinical trial of Livial® (tibolone) |
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Glucosamine and an elevated cholesterol level |
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Late pregnancy use of antidepressants may affect the newborn |
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Withdrawal of the medicinal product Exanta® |
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Increased risk of cardiac and renal adverse reactions from the use of Trasylol® |
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Adverse reactions from anaesthetics containing articaine (Septanest®, Septocaine®, Ubistesin®, Ubistesin Forte®) |
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Investigation of the safety of MRI contrast medium Omniscan® |
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Lamotrigine and increased risk of cleft palate/cleft lip |
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Herbal medicinal products containing black cohosh root and risk of liver injuries |
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Risks from using the skin creams Elidel® and Protopic® for eczema |
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Bisphosphonates and adverse reactions affecting the bones |
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NSAID and risk of cardiovascular adverse reactions |
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The Danish Medicines Agency, the National Board of Health and the Danish Environmental Protection Agency makes a statement about tooth whitening products |
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New recommendations on the use of MRI contrast agents in patients with impaired renal function |
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Risks in using medicinal products of the NSAID type |
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New recommendations for treatment of nocturnal enuresis in children |
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Possible increased risk of myocardial infarction in treatment with rosiglitazone (Avandia®, Avandamet®, Avaglim®) |
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Yasmin® does not cause more side-effects than other contraceptive pills |
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Assessment of adverse reactions from the medicinal products Permax® (pergolide) and Cabaser® (cabergoline) for Parkinson’s disease |
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The European Commission suggests initiatives focusing on medicinal product safety |
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Restricted use of piroxicam for pain relief |
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Adverse reactions to botulinum toxin (Botox®, Dysport®, Vistabel®, Neurobloc®) |
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Sun, heat and medicine |
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Weight loss product Acomplia® not to be used in patients with depression |
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Adverse reactions to botulinum toxin (Botox®, Dysport®, Vistabel®, Neurobloc®) - update |
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Adverse reactions to rosiglitazone (Avandia®, Avandamet®, Avaglim®) |
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Consumption and adverse reactions to treatment of attention and hyperactivity disorders in children |
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Adverse reactions reported from influenza vaccine |
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Avandia® and Actos® - cautious use in patients with heart conditions |
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Acomplia® (rimonabant) – risk of psychiatric reactions |
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EMEA recommends suspension of marketing authorisations for carisoprodol-containing medicinal products |
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Risk of severe hypersensitivity reactions from strontium ranelate-containing medicine |
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EMEA inserts new warnings about the use of Champix® (varenicline) |
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New review of bisphosphonates and osteonecrosis of the jaw by the European Pharmacovigilance Working Party |
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Safety regarding use of corticosteroids |
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Statement from EMEA regarding the safety of Gardasil® |
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Treatment of haemangioma with interferon |
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The Danish Medicines Agency warns against using skin lightening creams containing corticosteroids |
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The MRI contrast medium Omniscan® |
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The Danish Medicines Agency suspends marketing authorisation for Somadril® (carisoprodol) |
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Assessment of gadolinium-containing MRI contrast mediums - current status |
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Sclerosis medicine may cause liver injury |
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Recall of specific heparin batches |
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EMEA investigates potential risk of heart attack in HIV infected patients treated with abacavir |
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EMEA recommends new contraindication for Velcade® (bortezomib) |
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The cough remedy Dexofan® |
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Significant increase in adverse reactions reported by consumers |
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Report on the contrast medium Omniscan® |
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Use of angiotensin II receptor antagonists during pregnancy – updated product information |
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Analysis of heparin products on the Danish market |
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EMEA's Committee for Human Medicinal Products reviews heparin issues |
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Tests completed for heparin products on the Danish market |
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Renewed focus on adverse drug reactions from the use of Champix® (vareniciline) |
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EMEA strengthens warnings and contraindications for etoricoxib-containing medicines |
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EMEA recommends new warnings and contraindications for ergot-derived dopamine agonists |
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EMEA warns against the use of epoetins in cancer patients |
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Side effects from statins (simvastatin, pravastatin, lovastatin, fluvastatin, atorvastatin, rosuvastatin) |
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Antiepileptics and increased risk of suicidal thoughts and behaviour |
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EMEA assesses incidents of progressive multifocal leukoencephalopathy (PML) in sclerosis patients receiving Tysabri® |
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EMEA recommends update of the product information for the sclerosis medicine Tysabri® |
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Report all side effects from Gardasil® |
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EMEA recommends to suspend the licence for the weight-loss product Acomplia® across the EU |
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Second place isn’t good enough – the Danish Medicines Agency increases its focus on the reporting of adverse drug reactions |
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New information about cardiovascular adverse reactions from the use of NSAID |
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Conventional antipsychotics may cause increased risk of death in elderly people with dementia |
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From New Year the Danish Medicines Agency will take over the contact to doctors who report adverse reactions |
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The use of Omniscan for kidney patients |
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The MRI contrast agent Dotarem® |
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Atopic dermatitis and vaccination with Gardasil® |
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The European Medicines Agency (EMEA) recommends the European Commission to suspend the marketing authorisation of Raptiva® |
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The European Medicines Agency (EMEA) continues to recommend vaccination with Gardasil® |
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The benefits of ADHD medicine exceed the risks |
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Questions and answers about Gardasil® – human papillomavirus vaccine |
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No new adverse reactions suspected to be associated with the Gardasil® childhood vaccine |
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Side effects from Eltroxin® - status April 2009 |
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Research opens up questions about Botulinumtoxin A |
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Potential risk of interaction between clopidogrel and proton pump inhibitors |
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European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines |
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Uncertainty about insulin glargine (Lantus®) |
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Adverse reactions from Gardasil® in the period 1 September – 31 December 2009 |
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Mandatory electronic submission of adverse reaction reports |
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Template for pharmaceutical companies’ follow-up questions to reported adverse reactions |
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Adverse reactions from Gardasil® in the period 1 January – 30 April 2009 |
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Update on the safety of insulin glargine (Lantus®) |
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Contraceptive pills and the risk of blood clots |
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Side effects from medicines used to prevent or treat influenza A (H1N1) |
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Changed rules for reporting side effects as of 1 September 2009 |
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Survey: Doctors attach great importance to patient safety - a solid foundation to increase side effect reporting |
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Side effects from Eltroxin® - status October 2009 |
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Adverse reactions from Gardasil® in the period 1 May – 31 August 2009 |
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European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents |
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Gadolinium and nephrogenic systemic fibrosis: New recommendations from the European Medicines Agency |
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Side effects from Eltroxin® - status January 2010 |
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EMA updates warning on clopidogrel-containing medicines |
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Upgrade of the Danish Medicines Agency’s system for electronic transmission of adverse reaction reports via Eudravigilance gateway |
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Campaign at Danish pharmacies: ”Help us make medicine better for all” |
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Side effects from Eltroxin® - status July 2010 |
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New validation rules for electronic exchange of adverse reaction data via E2B from 15 September 2010 |
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Report a side effect |
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Reporting of adverse reactions from healthcare professionals |
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Report a side effect - patients and relatives |
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Guidelines for reporting side effects experienced by patients or relatives |
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Guidelines for reporting adverse drug reactions by doctors and other healthcare professionals |
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Reporting adverse reactions in animals |
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Guideline for the form for reporting suspected adverse reactions to the use of veterinary medicinal products |
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Reporting adverse reactions in Clinical trials |
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Electronic reporting of adverse reactions occurring in clinical trials on medicinal products for human use |
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Reporting of adverse reactions in clinical trials |
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Pamphlet on reporting side effects from medicine |
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The Council for Adverse Drug Reactions |
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Members of the Council for Adverse Drug Reactions |
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Minutes of meetings in the Council for Adverse Drug Reactions |
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Danish Pharmacovigilance Update |
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Periodic safety update reports |
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Pharmacovigilance/PSUR contacts at the Danish Medicines Agency |
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EU synchronisation of PSUR submission by pharmaceutical companies |
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EudraVigilance |
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Guidance on MedDRA version upgrade |
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The National Drug Interaction Database |
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Follow-up on adverse reaction reports |
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| Prices and Reimbursement |
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Prices |
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Pharmaceutical price indices |
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Medicine Prices (Medicinpriser) |
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Reimbursement |
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New rules for calculating the public reimbursement for medicinal products |
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General reimbursement |
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Reimbursement rules |
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Single reimbursement |
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Increased reimbursement |
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Reimbursement for the chronically ill |
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Reimbursement for the terminally ill |
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Medicines eligible for reimbursement |
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Frequently asked questions about reimbursement from citizens |
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New reimbursement thresholds from 1 January 2010 |
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Reimbursement prices |
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Am I using the least expensive medicine? |
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CTR - the Danish Medicines Agency's Central Reimbursement Register |
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The Reimbursement Committee |
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Calculate reimbursement |
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Publications on reimbursement |
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Number of applications for individual reimbursement of medicinal products in 2008 |
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Examination of single reimbursement for medicinal products |
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Applications for individual reimbursement of medicinal products in 2006 |
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Number of applications for individual reimbursement of medicinal products in 2009 |
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Information on medicinal product prices on Medicinpriser.dk |
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Substitution |
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Generic medicine and original medicine |
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Follow-up on consultation about generic substitution of epilepsy medicine on 21 March 2006 |
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Generic medicines are as effective as original products |
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Questions and answers about generic substitution |
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Special conditions concerning substitution of medicinal products containing ciclosporin |
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Original medicines are also copies |
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Decisions on general reimbursement for medicinal products |
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| Legislation |
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Easier access to acts and executive orders |
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Acts and executive orders |
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The Danish Medicines Act |
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The Danish Pharmacy Act |
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Amendment of Executive Order on Prescriptions |
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New executive order on the price list and delivery conditions |
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New executive order on clinical trials |
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Executive Order on marketing authorisation for medicinal products for consultation |
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Executive Order on reporting of adverse reactions and adverse events etc. from human tissue and cells for consultation |
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New rules for medicinal products for production animals |
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Amendment of Executive Order on Euphoriant Substances |
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New Executive Order on gasses for medical use |
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The fixed price system for medicinal products for production animals is abolished |
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New regulations for advanced therapy medicinal products, tissue engineering |
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The Danish Health Act |
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New Danish Health Act replaces the National Health Service Act |
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Executive order on access to and pursuit of activities as pharmacist in Denmark submitted for consultation |
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General principles of the regulation on advanced therapy medicinal products |
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New rules governing advanced therapy medicinal products |
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Executive Order on the submission of patient information leaflets to the Danish Medicines Agency submitted for public consultation |
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Ketamine and Methylone included in the executive order on euphoriant substances |
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Sale or delivery of advanced therapy medicinal products on 30 December 2008 |
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Executive order on fees payable for medicinal products, etc. |
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Implementation of Braille (raised dots for the blind and partially sighted) on medicine packages |
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Proposed amendment of the Medicines Act |
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New Medicines Act – questions and answers |
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The decentralised procedure - questions and answers |
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GMP requirements for manufacturers of active pharmaceutical ingredients (APIs) - questions and answers |
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Labelling - questions and answers |
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Sunset Clause and European Reference Product - questions and answers |
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Veterinary medicinal products - questions and answers |
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Pharmacovigilance - questions and answers |
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Amendment of Executive Order on euphoriants |
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Guidance on how to search for national legislation |
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Guidance on how to search for EU legislation |
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Guidelines on this website |
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Guidelines on advertising of medicinal products |
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Amendment of Executive Order on Labelling and new guidelines |
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Guidelines for good clinical practice |
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Proposal for provision on medicinal products for children |
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Definition of medicinal products |
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List of constituents |
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List of diseases |
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New executive order on application for reimbursement |
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Fees for authorisation and application |
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Fees for reporting prices and notifying pharmacies of prices of pharmacy-only pharmaceutical specialities |
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Fees for clinical trials |
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Application for annual fee exemption |
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Fees payable for medicinal products and companies |
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Fees on medicine containing narcotic drugs |
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Decisions on general reimbursement for medicinal products |
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New Executive Order on Medicinal Gases |
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Amendment of Executive Order on Euphoriant Substances |
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Draft guidelines for application for general reimbursement submitted for public consultation |
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Draft executive order amending the executive order on assignment of product codes to medicinal products |
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Executive order on calculation of consumer prices, etc. of medicinal products |
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Executive order on good laboratory practice for medicinal products |
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Amendment of executive order on euphoriant substances |
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Executive order on the reporting of information for medicinal product statistics |
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Executive order on the reporting of information on turnover etc. of medicinal products etc. |
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Draft executive order amending the executive order on labelling of medicinal products, etc. submitted for consultation |
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Amendment of executive order on euphoriant substances |
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New executive order on product numbers for medicinal products |
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Amendment of the Danish Health Act (1 January 2010) |
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Amendment of executive order on euphoriant substances |
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| Consumption and statistics |
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Consumption |
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General development of medicines used in Denmark |
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Consumption analyses |
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Price development |
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Pharmaceutical price indices |
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Statistics |
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Annual statistics |
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Consumption of antibiotics |
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The Danish population's use of medicines against major preventable diseases and disorders, by municipality |
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About the Register of Medicinal Product Statistics |
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| The Danish Medicines Agency |
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Mission, Vision and Values |
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Performance contracts |
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IT strategy |
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Perspectives and challenges |
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Clear Targets for 2009 |
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Organisation |
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Pharmacoeconomic Division |
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International Special Assignments |
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Administration Centre |
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Licensing Division |
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Executive Secretariat |
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Institute for Rational Pharmacotherapy |
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Medicines Control Division |
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New division for consumer safety at the Danish Medicines Agency |
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Chief Executive Officer Jytte Lyngvig |
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Digitisation Programme Office |
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Declaration of interest forms |
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Consumer Safety Division |
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Human Resources & Knowledge Management |
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Institute for Rational Pharmacotherapy |
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Committees and councils |
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The Council for Adverse Drug Reactions |
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The Reimbursement Committee |
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The Danish Pharmacopoeia Commission |
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Consultants on pharmacy licensing |
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The Licensing Committee |
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Networks and task forces |
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Network for the Prevention of Medication Errors |
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Fact sheets |
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Vacancies |
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Annual accounts and annual reports |
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Danish Medicines Agency annual accounts 2006 |
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Danish Medicines Agency Annual Report 2007 |
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Danish Medicines Agency annual accounts 2008 |
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Energy and environment |
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Directions |
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The Danish Medicines Agency's websites |
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About the website dkma.dk |
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Links |
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Phone directory |
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Contact us |
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If your company changes name or address |
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What is an EAN location number? |
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Handling of e-mail |
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Request for access to documents |
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Secure email at the Danish Medicines Agency |
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Guidelines for electronic invoicing |
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Phone directory |
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Review of applications for compassionate use permits around Ascension Day |
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Transparency - access to documents |
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Review of applications for compassionate use permits around Ascension Day |
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| Consumers |
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Indlaegsseddel.dk – your electronic package leaflet |
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Summaries of Product Characteristics (SPC) |
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Faster access to summaries of product characteristics online |
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New links for summaries of product characteristics |
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Guidance for finding summaries of product characteristics for centrally authorised medicinal products |
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Search for medicine prices |
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Reimbursement |
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New rules for calculating the public reimbursement for medicinal products |
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General reimbursement |
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Single reimbursement |
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Reimbursement rules |
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Increased reimbursement |
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Reimbursement for the chronically ill |
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Reimbursement for the terminally ill |
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Medicines eligible for reimbursement |
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Frequently asked questions about reimbursement from citizens |
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New reimbursement thresholds from 1 January 2010 |
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Reimbursement prices |
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Am I using the least expensive medicine? |
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CTR - the Danish Medicines Agency's Central Reimbursement Register |
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Warnings |
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Healthcare professionals to stay aware of mix-ups between solutions for infusion or irrigation |
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Warning against the product Prostasol with oestrogen |
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Warning against the potency-enhancing product Rock Hard Weekend |
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Warning: Counterfeit Cipralex® found in Egypt |
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Warning against the Malaysian product Libidus with the substance vardenafil |
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Warning: Illegal copy of the medicinal product Cialis® sold on the internet |
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Warning: Sale of illegal diet pills |
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Chinese products containing tadalafil, sildenafil and sibutramine |
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Preparations with wrong indication of constituents |
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Kamagra tablets with sildenafil |
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Heavy metals in products for traditional Indian healing |
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Warning on adverse reactions from Coleus Forskolii Briq |
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Warning: Illegal copies of medicinal products with the active substance rimonabant sold on the internet |
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Illegal anti-impotence drug sold via coupon leaflets |
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Warning: Counterfeit Xenical® sold via the internet |
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Withdrawal of Serevent® inhalation powder in Diskos® 50 microgram/dose |
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Warning: Counterfeit versions of the medicinal product Tertensif® found in Bulgaria |
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Warning: Unauthorised sale of donated sperm from the sperm bank A.I. Sædbank |
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Counterfeit versions of the medicinal products Plavix® and Casodex@ found in Great Britain |
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Counterfeit versions of the medicinal product Zyprexa® found in Great Britain |
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Warning: Illegal sibutramine-containing weight-loss products sold on the internet |
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Marketing of Trasylol® (aprotinin) temporarily suspended by Bayer Healthcare Pharmaceuticals |
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The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against the weight loss product Therma Power |
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Warning against the products Herb Vigour, China Vigour and Natural Vigour |
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Warning about Power 1 Walnut |
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Warning against vpxl N°1 Dietary Supplement for Men |
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Warning: Counterfeit packages of Cipralex® found in Pakistan |
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Warning against the product Wodibo |
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Warning against the product Melanotan |
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Warning about unauthorised distribution of donated sperm from the sperm bank A.I. Sædbank |
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Danish Medicines Agency warns against the weight-loss product Therma Power |
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Recall of Nobligan® oral drops in Denmark |
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Warning against the product Viamax Energizer |
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Withdrawal of the asthma and lung medicine Oxis Turbohaler® with batch no. IA763-3 |
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Warning on Hydroxycut pills |
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Beware of mix-ups between products containing mirtazapine and mianserin |
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Warning: Counterfeit Viagra® sold on Danish website |
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Warning against the weight-loss product Super Slim |
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Warning against counterfeit Alli® from the USA |
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Updated warning against counterfeit Alli® from the USA |
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Warning against pills from IDS Sports |
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Warning against ‘Alscreme Creme nr. 2’ from www.eminescu.dk |
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Focus on safe handling and use of pain-relief patches |
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Alscreme 'Creme nr. 2' – information for Danish physicians |
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Strengthened warning against Alscreme 'Creme nr. 2' from www.eminescu.dk |
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The Danish Medicines Agency warns against the use of silicone breast implants manufactured by Poly Implant Prothèse, France |
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EMA reassesses cardiovascular safety of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim) |
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Doping products |
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Consultative list of substances covered by section 1 of Act no. 232 of 21 April 1999 on prohibition of certain doping agents |
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Medicinal products affecting the ability to drive |
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List of medicinal products affecting the ability to drive |
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Counterfeit medicinal products |
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Danes' buying of medicine on the internet and abroad – survey |
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Major increase in medicinal products seized by customs |
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The pursuit of a better sex life can be detrimental to your health |
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Import of medicinal products |
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Medicinal products on the Internet |
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Medicines retained by Danish customs |
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Medicinal products at customs |
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Inquire about import |
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Medicines control |
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Control of selected medicinal products |
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Control of the medicinal product Curosurf® |
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Control of medicinal product labelling (spring 2008) |
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Renewed accreditation of the Danish Medicines Agency’s laboratory |
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Control of DiTeKiPol/Act-Hib vaccine |
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Control of selected suppositories |
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Control of the labelling of selected medicinal products |
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Control of Normosang |
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Control of medicinal products with growth hormone (Somatropin) |
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Control of the medicinal product Pulmozyme® |
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Control of veterinary vaccines for dogs and cats |
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Control of vaccines for humans |
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Control of the quality of 264 medicinal products |
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Control of heparins |
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Control of Thymoglobuline |
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Control of turbuhalers with inhalation powder |
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Control of medicinal product labelling |
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Control of selected veterinary antibiotics |
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|
Control of inappropriate packaging of the DiTeKiPol-ActHib vaccine |
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|
Control of Imukin (interferon gamma 1b) |
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Control of poultry vaccines |
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Control of oral suspensions |
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Control of streptokinase-containing medicinal products |
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Control of medicinal product labelling (fall 2008) |
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Control of Eprex® |
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Compliance check of package leaflets and product labelling (spring 2009) |
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Control of Granocyte® |
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Control of Neupogen® and Neupogen Novum® |
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Compliance check of package leaflets and product labelling (winter 2009/2010) |
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Glossary |
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Pharmacovigilance |
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Registration and monitoring of side effects |
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Information on adverse drug reactions |
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Report a side effect |
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|
Reporting adverse reactions in animals |
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Reporting adverse reactions in Clinical trials |
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|
Danish Pharmacovigilance Update |
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|
Pamphlet on reporting side effects from medicine |
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|
The Council for Adverse Drug Reactions |
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|
Periodic safety update reports |
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|
|
EudraVigilance |
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|
|
The National Drug Interaction Database |
|
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|
|
Follow-up on adverse reaction reports |
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|
|
Frequently asked questions from consumers |
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|
|
Why haven’t I received your newsletter? |
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|
Why can’t I open Excel files? |
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|
Why can’t I open PDF files? |
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|
Where can I find a list of medicinal products authorised in Denmark? |
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|
Where can I find my balance in the CTR? |
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|
|
When can I get reimbursement? |
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|
What are the criteria for obtaining single reimbursement? |
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|
How can I access the Medicine Profile? |
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| Doctors |
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|
Medicinal Products |
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|
|
Quality monitoring of veterinary vaccines |
|
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|
|
Indlaegsseddel.dk – your electronic package leaflet |
|
|
|
|
Publication of information on medicinal products |
|
|
|
|
Summaries of Product Characteristics (SPC) |
|
|
|
|
Lists with information about medicinal products |
|
|
|
|
Medicinal products affecting the ability to drive |
|
|
|
|
Radiopharmaceuticals |
|
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|
|
Herbal medicinal products etc. |
|
|
|
|
Doping products |
|
|
|
|
Veterinary medicinal products |
|
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|
|
Classification of electronic cigarettes |
|
|
|
|
Classification of electronic cigarettes |
|
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|
|
Veterinary premix and medicated feed |
|
|
|
Compassionate use permits |
|
|
|
|
Compassionate use permit for experimental treatment with medicinal products |
|
|
|
Reimbursement system |
|
|
|
|
Case handling times for individual reimbursement |
|
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|
|
Information on reimbursement |
|
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|
|
Reimbursement |
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|
|
|
Doctor pamphlet |
|
|
|
|
Guiding criteria for single reimbursement |
|
|
|
Frequently asked questions from doctors |
|
|
|
|
Why can't I open Excel files? |
|
|
|
|
Where can I find a list of medicinal products authorised in Denmark? |
|
|
|
|
Why can't I open PDF files? |
|
|
|
|
Why haven't I received your newsletter? |
|
|
|
|
Where can I find summaries of product characteristics? |
|
|
|
Medicines control |
|
|
|
|
Control of selected medicinal products |
|
|
|
|
Control of the medicinal product Curosurf® |
|
|
|
|
Control of medicinal product labelling (spring 2008) |
|
|
|
|
Renewed accreditation of the Danish Medicines Agency’s laboratory |
|
|
|
|
Control of DiTeKiPol/Act-Hib vaccine |
|
|
|
|
Control of selected suppositories |
|
|
|
|
Control of the labelling of selected medicinal products |
|
|
|
|
Control of Normosang |
|
|
|
|
Control of the medicinal product Pulmozyme® |
|
|
|
|
Control of medicinal products with growth hormone (Somatropin) |
|
|
|
|
Control of veterinary vaccines for dogs and cats |
|
|
|
|
Control of vaccines for humans |
|
|
|
|
Control of the quality of 264 medicinal products |
|
|
|
|
Control of heparins |
|
|
|
|
Control of Thymoglobuline |
|
|
|
|
Control of turbuhalers with inhalation powder |
|
|
|
|
Control of medicinal product labelling |
|
|
|
|
Control of selected veterinary antibiotics |
|
|
|
|
Control of inappropriate packaging of the DiTeKiPol-ActHib vaccine |
|
|
|
|
Control of Imukin (interferon gamma 1b) |
|
|
|
|
Control of poultry vaccines |
|
|
|
|
Control of oral suspensions |
|
|
|
|
Control of streptokinase-containing medicinal products |
|
|
|
|
Control of medicinal product labelling (fall 2008) |
|
|
|
|
Control of Eprex® |
|
|
|
|
Compliance check of package leaflets and product labelling (spring 2009) |
|
|
|
|
Control of Granocyte® |
|
|
|
|
Control of Neupogen® and Neupogen Novum® |
|
|
|
|
Compliance check of package leaflets and product labelling (winter 2009/2010) |
|
|
|
Substitution |
|
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|
|
Increasingly stringent requirements for authorisation of substitution for epilepsy medicine |
|
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|
|
Follow-up on consultation about generic substitution of epilepsy medicine on 21 March 2006 |
|
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|
|
Generic medicines are as effective as original products |
|
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|
|
Special conditions concerning substitution of medicinal products containing ciclosporin |
|
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|
|
Generic medicine and original medicine |
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|
|
Original medicines are also copies |
|
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|
|
Questions and answers about generic substitution |
|
|
|
Doctors associated with pharmaceutical companies |
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|
|
Guideline on the obligation to apply for doctors and dentists wanting to be associated with a pharmaceutical company |
|
|
|
Pharmacovigilance |
|
|
|
|
Registration and monitoring of side effects |
|
|
|
|
Information on adverse drug reactions |
|
|
|
|
Pamphlet on reporting side effects from medicine |
|
|
|
|
The Council for Adverse Drug Reactions |
|
|
|
|
Periodic safety update reports |
|
|
|
|
EudraVigilance |
|
|
|
|
The National Drug Interaction Database |
|
|
|
|
European Medicines Agency recommends suspension of marketing authorisations for sibutramine due to increased risk of cardiovascular events |
|
|
|
|
Follow-up on adverse reaction reports |
|
|
|
Clinical trials |
|
|
|
|
Information on clinical trials |
|
|
|
|
Guidelines and forms for clinical trials |
|
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|
|
Assessment times for clinical trial applications |
|
|
|
|
Fees for clinical trials |
|
|
|
|
EudraCT - the Community Clinical Trial system |
|
|
|
|
Executive order on clinical trials on medicinal products, human use |
|
|
|
|
The European Commission publishes Volume 10 – clinical trials |
|
|
|
|
Clinical trials of medicinal products |
|
|
|
|
Guideline for first-in-man clinical trials |
|
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|
|
Reflection paper from EMEA's GCP Inspectors Working Group on expectations for electronic source documents used in clinical trials |
|
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|
|
Use of waivers in connection with the inclusion of trial subjects/patients in clinical trials |
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|
|
Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications |
|
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|
|
EU directive does not result in fewer clinical trials from independent researchers |
|
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|
|
Amendments to clinical trials |
|
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|
|
Changed definition of safe contraception in clinical trials |
|
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|
|
FAQ on clinical trials |
|
|
| Companies |
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|
|
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|
|
Authorisation of medicinal products |
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|
|
Guidelines and forms |
|
|
|
|
Contact the Licensing Division |
|
|
|
|
Package leaflet database |
|
|
|
|
Authorisation of medicinal products |
|
|
|
|
Number of cases on the authorisation of medicinal products in 2006 |
|
|
|
|
Assessment times for authorisation of medicinal products |
|
|
|
|
Order Books |
|
|
|
|
Number of cases on the authorisation of medicinal products in 2007 |
|
|
|
|
Number of cases on the authorisation of medicinal products in 2008 |
|
|
|
|
Fees payable for medicinal products and companies |
|
|
|
|
Number of cases on the authorisation of medicinal products in 2009 |
|
|
|
|
Licensing of medicines – prioritisation and forecast processing times for the first half of 2010 |
|
|
|
|
Number of cases on the authorisation of medicinal products in 2010 |
|
|
|
|
Licensing of medicines – prioritisation and forecast processing times for the second half of 2010 |
|
|
|
Authorisation of companies |
|
|
|
|
Guidelines and forms |
|
|
|
|
Information on GLP |
|
|
|
|
FAQs on GMP |
|
|
|
|
Fees for authorisation and application |
|
|
|
|
New practice for authorisation of qualified persons on section 39 authorisations |
|
|
|
|
Questions and answers about procedure for authorisation of several qualified persons on section 39 authorisations (new scheme) |
|
|
|
|
Notification to medicines manufacturers about reduced testing of raw materials |
|
|
|
Medicine Prices (Medicinpriser) |
|
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|
|
Prices & Packages |
|
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|
|
Notifications for Medicine Prices |
|
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|
|
Lower limit for price changes |
|
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|
Electronic version of Medicine Prices |
|
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|
Delivery failure |
|
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New rules for reporting to the Price List from 1 April 2005 |
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Changes to the Pricelist |
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Failure in delivery |
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Medicinal product groups |
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Medicine Prices for companies |
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Subscription to Medicine Prices for companies |
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Deadlines for notifications to Medicine Prices |
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Conversion from AIP (pharmacy purchase price) to ESP (consumer price) |
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Notification of supply conditions |
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Change of the content of the fields ’Number of DDD per package’ and ’Price per DDD’ |
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DKMAnet |
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Prices & Packages |
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Package leaflet database |
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DKMAnet is up and running again |
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DKMAnet.dk is temporarily unavailable |
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DKMAnet is up and running again |
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General reimbursement |
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Application for general reimbursement |
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Reassessment of reimbursement status for medicinal products |
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Export certificates |
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Export certificates - new rules |
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Guidelines for issuing export certificates for medicinal products |
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Product code |
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Medicine containing narcotic drugs |
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Guidelines and forms |
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Fees on products containing narcotic drugs |
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Amendment of executive order on euphoriant substances |
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Amendment of Danish executive order on euphoriant substances |
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Control and standards |
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Medicines control |
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Danish Drug Standards |
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Clinical trials |
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Information on clinical trials |
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Guidelines and forms for clinical trials |
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Assessment times for clinical trial applications |
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Fees for clinical trials |
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FAQ on clinical trials |
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Doctors, dentists and pharmacist associated with a pharmaceutical company |
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Guideline on notification of information about doctors, dentists or pharmacists associated with a pharmaceutical company |
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Tissues and Cells |
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Guidelines and forms |
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Register of authorised tissue establishments |
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Information on tissues and cells |
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Product defects and withdrawals of medicinal products |
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Reporting of product defects that may lead to a withdrawal |
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Practice for complaints and withdrawal handling at the Danish Medicines Agency |
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Pharmacovigilance |
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Registration and monitoring of side effects |
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Information on adverse drug reactions |
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Pamphlet on reporting side effects from medicine |
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The Council for Adverse Drug Reactions |
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Periodic safety update reports |
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EudraVigilance |
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The National Drug Interaction Database |
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Follow-up on adverse reaction reports |
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European Medicines Agency recommends suspension of marketing authorisations for sibutramine due to increased risk of cardiovascular events |
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Frequently asked questions from companies |
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Where can I find a list of medicinal products authorised in Denmark? |
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Why haven’t I received your newsletter? |
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Why can’t I open Excel files? |
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Why can’t I open PDF files? |
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Where can I find a list of medicinal products no longer on the Danish market? |
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Where can I find information about deadlines for authorisation of medicinal products? |
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How do I pay the Danish Medicines Agency? |
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Where can I find summaries of product characteristics? |
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| Retailers |
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Community pharmacies |
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Foreign pharmacy staff |
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Pharmacy licensing |
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Medicine Prices (Medicinpriser) |
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Dose dispensing |
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Over-the-counter sales outlets |
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Schengen certificates |
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Pharmacy reimbursement |
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Pill passport |
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Over-the-counter medicinal products |
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OTC medicines and release for sale outside pharmacies |
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More medicinal products sold in general sale outlets |
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Thresholds for the total amount of active substance in certain medicinal products sold in general sales outlets |
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Changed basic range of over-the-counter medicinal products |
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Retailers |
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Guidelines and forms |
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Announcements |
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Fees for retailers |
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| Press |
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Phone directory |
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New phone directory at dkma.dk |
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News archive |
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News archive 2007 |
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News archive 2006 |
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News archive 2008 |
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Photos |
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Subscribe to NetNews |
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Subscribe to Indication |
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Fact sheets |
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News |
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Information |
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Possibilities on the website |
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Tamiflu®: Beware of counterfeits! |
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The Danish Medicines Agency |
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News via RSS Feed |
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Scabies medicine on its way to Denmark |
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TOPRA Symposium from 3-5 October 2007 |
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Scabies medicine on its way to Denmark |
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News |
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Publications |
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Newsletter |
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