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21 December 2010 /Retail and online sale
The Danish Medicines Agency warns against illegal version of Pregnyl
The pharmaceutical company Missionpharma A/S has alerted the Danish Medicines Agency that an illegal version of the medicine Pregnyl is in circulation.
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21 December 2010 /News - medical devices
Danish Medicines Agency sends out acknowledgement letters and decisions electronically
The Danish Medicines Agency will be sending out acknowledgement letters and decisions to companies, researchers, etc. electronically, in so far as we have a registered email address for the person(s) that we primarily correspond with
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20 December 2010 /Product areas
Check your Mini Crosser el-scooter if it is more than four years old
Older versions of el-scooters (Model T and Model Nordic) could have problems with the electronics and therefore need to be adjusted.
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17 December 2010 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance pyrazinamide
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the following Certificate og Suitability. CEP R1-1998-070-Rev02 Pyrazinamide
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17 December 2010 /News - miscellaneous
Recommendation for doctors and dialysis patients in connection with peritoneal dialysis solutions from Baxter A/S
The European Medicines Agency (EMA) recommends that all batches of Baxter's peritoneal dialysis solutions, Extraneal®, Nutrineal® and Dianeal® be replaced.
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16 December 2010 /News - miscellaneous
Moderate catch in fitness centres
The Danish Veterinary and Food Administration and the Danish Medicines Agency only found a small number of violations of the Danish Food Act and the Danish Medicines Act during a joint on-site inspection of some 30 fitness centres and clubs in autumn 2010.
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14 December 2010 /Product information
Warning against dangerous "natural" potency-enhancing product
The Danish Medicines Agency strongly warns against using the potency-enhancing product marketed as POWERtabs based on information from the Norwegian drug regulatory authorities that a Norwegian man needed treatment after having taken the potency-enhancing product.
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13 December 2010 /Side effects and trials
Exercise particular caution when using Extraneal Viaflex® and Nutrineal Viaflex® peritoneal dialysis solution
A number of units of Baxter’s peritoneal dialysis solution of the brands Extraneal® and Nutrineal® manufactured in Ireland are suspected of containing a too high content of endotoxin. A too high content of endotoxin may pose a risk of aseptic peritonitis (infection of abdominal fluid).
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10 December 2010 /Side effects and trials
Update of validation rules for electronic reporting of adverse reactions
We are updating the validation rules in connection with the implementation of the Danish Medicines Agency's new adverse reaction database. The changes, which entered into force on 6 December 2010, are.
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02 July 2010 | Updated 10 December 2010 /Retail and online sale
OTC medicines and release for sale outside pharmacies
In consultation with the Licensing Committee, the Danish Medicines Agency has adopted a new practice, describing when an over-the-counter (OTC) medicine is released for sale outside pharmacies.
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06 December 2010 /About us
Danish Medicines Agency sends out acknowledgement letters and decisions electronically
The Danish Medicines Agency will be sending out acknowledgement letters and decisions to companies, researchers, etc. electronically, in so far as we have registered email address for the person(s) that we primarily correspond with.
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29 November 2010 /Side effects and trials
Delay in acknowledgements for adverse reactions submitted from 1 December to 6 December 2010
Companies submitting electronic adverse reaction reports to the Danish Medicines Agency in the period from 1 Dece´mber up to and including 6 December are advised that the electronic acknowledgement will be delayed.
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance rifampicin
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificate of Suitability (CEP) for the active substance rifampicin
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances oxytetracycline HCl and phenoxymethylpenicillin potassium
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificates of Suitability (CEP) for the active substances Oxytetracycline HCl (CEP 1999-162) abd Phenoxymethylpenicillin pottassium (CEP 2006-019)
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16 November 2010 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances metronidazole and caffeine
The European Directorate for the Quality of Medicines and Healthcare, EDQM, has suspended the Certificates of Suitability (CEP) for the active substances metronidazole (R1-CEP 2002-119-Rev 00) and caffeine (R0-CEP 2005-116-Rev 01)
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12 November 2010 /News - miscellaneous
Heads of Medicines Agencies adopts new strategy
The Heads of Medicines Agencies (HMA) has adopted a new strategy for 2011-2015 at the HMA meeting in Antwerp on 25 October 2010. The key themes of the strategy are.
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10 November 2010 /Side effects and trials
Pregnancy and use of over-the-counter painkillers
A new Danish study has shown that the use of paracetamol during pregnancy may be associated with an increased risk of cryptorchidism in baby boys at birth1. Cryptorchidism is a condition where the testicles have not descended into the scrotum at birth.
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29 October 2010 /Side effects and trials
Assessment of safety of methylphenidate in ADHD treatment
The Danish Medicines Agency has reviewed the data on consumption and side effects of methylphenidate-containing medicine, which is authorised for the treatment of ADHD and narcolepsy.
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29 October 2010 /Side effects and trials
Implementation of MedDRA version 13.1
MedDRA (Medical Dictionary for Regulatory Activities) is a code book of medical terminology developed by ICH (International Conference on Harmonisation).
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25 October 2010 /Side effects and trials
Adjustment of new validation rules for electronic exchange of adverse reaction data
On 11 October, the Danish Medicines Agency, implemented the updated validation rules for electronic exchange of E2B files ((ICH E2B (R2)) EV7 Release 1.
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22 October 2010 /Product information
Important information for diabetics: GlucaGen® Hypokit 1 mg for injection recalled in Denmark
Novo Nordisk A/S in Denmark is recalling a defective batch of GlucaGen® Hypokit, which is used to treat severe hypoglycaemia (low blood sugar) in diabetes.
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20 October 2010 /Prices and reimbursement
General reimbursement for medicines containing losartan in combination with hydrochlorothiazide
Patients can now receive general reimbursement for all medicines containing losartan in combination with hydrochlorothiazide. This also includes medicines containing a combination of losartan 100 mg and hydrochlorothiazide 12.5 mg
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18 October 2010 /News - miscellaneous
Expiry of transitional arrangement for traditional herbal medicinal products and natural medicinal products
Since 2005, it has been possible in Denmark to have traditional herbal medicinal products registered as an alternative way of bringing herbal medicines onto the Danish market.
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14 October 2010 /Retail and online sale
Global operation targeting illegal and counterfeit medicines
More than 40 countries have taken part in an international week of action targeting the online sale of counterfeit and illegal medicines to raise awareness of the associated health risks, resulting in arrests across the globe and the seizure of thousands of potentially harmful medicines.
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06 October 2010 /Side effects and trials
Implementation of new validation rules for electronic exchange of adverse reaction data
Companies which report adverse reaction data to the Danish Medicines Agency are advised that on Monday 11 October 2010, we will be implementing the updated (ICH E2B (R2)) validation rules for the exchange of E2B files, which entered into force on 1 June 2010.
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29 September 2010 /Product areas
Problems with breast implants
On 8 April 2010, the Danish Medicines Agency warned against the use of breast implants pre-filled with silicone based gel labelled IMGHC-TX, IMGHC-MX or IMGHC-LS manufactured by the French company Poly Implant Prothèse.
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24 September 2010 /Side effects and trials
EMA recommends suspension of rosiglitazone-containing medicines (Avandia®, Avandamet® and Avaglim®)
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has reviewed the benefits and risks of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim) used in diabetes care.
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23 September 2010 /About us
Focus on cooperation with Chinese authorities
A business visit to Shanghai and Beijing in September has strengthened collaboration between the Danish Medicins Agency and its Chinese counterpart, SFDA.
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22 September 2010 /Side effects and trials
Octagam® recalled by the Danish Medicines Agency
Based on increased reports of blood clots from the use of Octagam® 50 mg/ml in 2010, the Danish Medicines Agency has decided to recall Octagam® in Denmark. Octagam® is available in two strengths (50 mg/ml and 100 mg/ml) both of which are recalled.
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15 September 2010 /Side effects and trials
React to serious and unexpected side effects
In week 37 the Danish Medicines Agency launches a nationwide campaign, setting out to encourage hospital doctors to be more active in reporting serious and unexpected side effects from medicine. The Danish Medicines Agency runs this campaign because it estimates that whenever one side effect is reported by a hospital doctor another 50 serious or unexpected side effects go unreported.
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15 September 2010 /News - miscellaneous
Danish authorities focus efforts on fitness centres
Illegal medicines under the counter, unauthorised sale of food supplements in the back? Next week, the Danish Veterinary and Food Administration and the Danish Medicines Agency concentrate their efforts to combat the distribution of illegal food supplements and medicines in fitness centres and fitness clubs across Denmark.
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02 September 2010 /Product areas
Much debated dental crowns pose no health risk
On 29 August, DR TV (Danish Broadcasting Corporation) broadcast a story on the Danish company Oversea Labs about gold dental crowns.
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31 August 2010 /Product areas
About gold dental crowns from Oversea Labs: Experts assess there to be no health risk associated with the dental crowns
On 29 August, DR TV (Danish Broadcasting Corportaion) broadcast a story on the Danish company Oversea Labs, revealing that the company's gold dental crowns according to DR's analysis of five teeth did not contain as much gold as they were supposed to.
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26 August 2010 /Side effects and trials
Evaluation of possible link between Pandemrix® and narcolepsy
The Medical Products Agency in Sweden is evaluating a possible link between the H1N1 vaccine, Pandemrix®, and the neurological disorder narcolepsy.
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09 August 2010 /News - miscellaneous
Danish authorities assess risk of calcium supplements
Do calcium supplements increase the risk of blood clots? Are changes to the official recommendations required? These questions are now being discussed by the Danish Veterinary and Food Administration and the Danish Medicines Agency, etc. after an article in the British Medical Journal (BMJ) suspected calcium supplements of increasing the risk of heart attacks.
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27 July 2010 /About us
Conclusions and recommendations from the Pharmaceutical Forum
The High Level Pharmaceutical Forum was officially concluded in October 2008 with the adoption of a number of recommendations and conclusions within three themes explored by the Forum.
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26 July 2010 /Product information
EMA reassesses cardiovascular safety of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim)
In July, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) once again initiated a review of the benefit-risk profile of rosiglitazone-containing medicines, which in Denmark are used to a very limited degree for the treatment of type 2 diabetes.
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22 July 2010 /Product information
Updated monographs for Heparin calcium (0332) and Heparin sodium (0333) for implementation in the European Pharmacopoeia (Ph. Eur.) as of 1 August 2010
As a follow-up on the work on improving the analysis methods for potentially contaminated heparin preparations, the European Pharmacopoeia Commission has adopted two revised monographs for Heparin calcium (0332) and Heparin sodium (0333) which will be implemented in the European Pharmacopoeia (Ph. Eur.) from 1 August 2010.
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13 July 2010 /News - miscellaneous
Consultation on the Heads of Medicines Agencies’ Strategy Paper for 2011-2015
The Heads of Medicines Agencies (HMA) has drawn up a draft strategy document for the period 2011-2015. As part of the strategy development process, the HMA now gives its key stakeholder groups an opportunity to comment on the strategy's content.
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09 July 2010 /Authorisation and supervision
Licensing of medicines – prioritisation and forecast processing times for the second half of 2010
We still find it important to maintain a high level of participation as rapporteur/co-rapporteur in applications under the centralised procedure as well as a high level of engagement in providing scientific advice to the EMA.
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06 July 2010 /Side effects and trials
New validation rules for electronic exchange of adverse reaction data via E2B from 15 September 2010
Companies that report adverse reaction data to the Danish Medicines Agency are advised that new validation rules for electronic exchange of E2B files soon enter into force.
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05 July 2010 /Authorisation and supervision
Notification to medicines manufacturers about reduced testing of raw materials
The Danish Medicines Agency has become aware that there is some uncertainty about the possibility of using reduced testing of raw materials, including active pharmaceutical ingredients (API).
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05 July 2010 /Side effects and trials
Side effects from Eltroxin® - status July 2010
In 2009, the Danish Medicines Agency recorded a rise in the number of reported side effects (adverse reactions) from Eltroxin® after the manufacturer changed the excipients contained in Eltroxin®.
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16 June 2010 /About us
Danish Chair of European group of experts
Anja Holm, Veterinarian at the Danish Medicines Agency, is elected Chair of the European Commission's Committee for Medicinal Products for Veterinary Use (CVMP).
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15 June 2010 /Authorisation and supervision
Implementation of Braille (raised dots for the blind and partially sighted) on medicine packages
Please be advised that the name and strength in Braille (raised dots for the blind and partially sighted people) must appear on the outer packaging of medicine packages in Denmark, cf. section 12 of the Danish executive order on labelling
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14 June 2010 /Prices and reimbursement
Change of the reimbursement for certain cardiovascular products as of 15 November 2010
The Reimbursement Committee and the Danish Medicines Agency have reviewed some of the medicinal products used for the treatment of cardiovascular disease (antihypertensives) in order to assess whether they meet the criteria for public reimbursement. The medicinal products concerned are the so-called angiotensin II antagonists and renin inhibitors.
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14 June 2010 /Prices and reimbursement
Changes in reimbursements for anti-ulcer medicines
The Reimbursement Committee and the Danish Medicines Agency have reviewed medicinal products for the treatment of heartburns, sour eructations and ulcers ('acid-related disorders') in order to assess whether they meet the criteria for public reimbursement.
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03 June 2010 /Prices and reimbursement
Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)
The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors) was open for consultation until 7 May 2010.
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01 June 2010 /Side effects and trials
Campaign at Danish pharmacies: ”Help us make medicine better for all”
”Help us make medicine better for all” is the message of a new campaign from the Danish Medicines Agency. Via Danish pharmacies, it focuses on how medicine users can report side effects from their medicine.
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10 May 2010 /Side effects and trials
Side effects from Pandemrix® from 23 January to 18 April 2010
In the period from 23 January to 18 April 2010, the Danish Medicines Agency received 35 new side effect reports covering a total of 97 suspected side effects (adverse reactions).
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04 May 2010 /Side effects and trials
Upgrade of the Danish Medicines Agency’s system for electronic transmission of adverse reaction reports via Eudravigilance gateway
On 5 May 2010, the Danish Medicines Agency will perform an upgrade of the system for transmission of adverse reaction reports between the European Medicines Agency and the pharmaceutical companies (Cyklone to Axway version 5.2.2)
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21 April 2010 /Authorisation and supervision
The Danish Medicines Agency resumes the allocation of time slots for the second half of 2011
From 3 May 2010 to 31 May 2010 (both days included) the Danish Medicines Agency resumes the allocation of time slots for the second half of 2011.
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21 April 2010 /Prices and reimbursement
Decision on future reimbursement status of losartan-containing medicines (C09CA01 and C09DA01) - angiotensin II antagonists
On 16 April 2010, the Danish Medicines Agency decided on the future reimbursement status of some of the losartan-containing medicines in ATC groups C09C and C09D, making these products eligible for general reimbursement as of 19 April 2010.
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09 April 2010 /Prices and reimbursement
Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)
The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders) was open for consultation until 15 March 2010.
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09 April 2010 /Product areas
The Danish Medicines Agency warns against the use of silicone breast implants manufactured by Poly Implant Prothèse, France
The Danish Medicines Agency warns against the use of silicone gel filled breast implants marked IMGHC-TX, IMGHC-MX or IMGHC-LS manufactured by the French company Poly Implant Prothèse
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31 March 2010 /Prices and reimbursement
Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)
At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors).
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26 March 2010 /Product information
EMA recommends recall of clopidogrel products from Acino Pharma GmbH
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has been made aware of quality problems with the manufacturing process at the factory which supplies the active substance for the manufacturing of eight clopidrogel-containing products.
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25 March 2010 /News - miscellaneous
Danish Medicines Agency co-organises biosimulation workshop on 11 March 2010
The Danish Medicines Agency co-organises a workshop on biosimulation taking place on Thursdag 11 March 2010 in the city of Lund in Sweden.
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24 March 2010 /Prices and reimbursement
The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of medicines in ATC groups C09C, C09D and C09X
On 8 March 2010, a number of pharmaceutical companies put generic copies of the angiotensin II antagonist losartan on the market at prices comparable to those of the cheapest ACE inhibitors.
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22 March 2010 /Side effects and trials
EMA updates warning on clopidogrel-containing medicines
In May 2009, the European Medicines Agency (EMA) raised concern about a possible risk of interaction between proton pump inhibitors (PPI) and clopidogrel-containing medicines.
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11 March 2010 /Product information
Strengthened warning against Alscreme 'Creme nr. 2' from www.eminescu.dk
On 12 February 2010, the Danish Medicines Agency warned strongly against using the product Alscreme 'Creme nr. 2' sold via www.eminescu.dk, as the product is an unlicensed medicinal product that contains active substance clobetasol.
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08 March 2010 /About us
Chief Medical Officer of the Danish Medicines Agency appointed new member of the EU Pharmacovigilance Working Party
Torbjörn Callréus, Chief Medical Officer of the Danish Medicines Agency's Consumer Safety Division has been appointed co-opted expert for the European Medicines Agency's Pharmacovigilance Working Party, PhVWP
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03 March 2010 /Product information
Updating of summary of product characteristics prompted by changed ATC codes for 2010
Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure should be aware that som ATC codes have been changed in 2010.
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25 February 2010 /Side effects and trials
Adverse reactions from Gardasil® in the period 1 September – 31 December 2009
In the period from 1 September to 31 December 2009, the Danish Medicines Agency received 22 adverse reaction reports with a total of 52 suspected side effects from Gardasil®.
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19 February 2010 /Prices and reimbursement
Reassessment of the reimbursement status of ATC group A – alimentary tract and metabolism
The Danish Medicines Agency will begin its reassessment of ATC group A, alimentary tract and metabolism, which includes.
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19 February 2010 /News - miscellaneous
Spot checking of distribution of medical samples for the year 2007
The Danish Medicines Agency performs spot checks of Danish pharmaceutical companies’ distribution of free medical samples for doctors, dentists and veterinarians.
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16 February 2010 /Product information
Warning against ‘Alscreme Creme nr. 2’ from www.eminescu.dk
The Danish Medicines Agency warns strongly against use of the product 'Alscreme Creme nr. 2' sold via www.eminescu.dk, as the product is an unauthorised medicinal product containing the active substance clobetasol.
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03 February 2010 /Authorisation and supervision
Licensing of medicines – prioritisation and forecast processing times for the first half of 2010
The changed administrative procedure that was introduced for national applications in the summer of 2009 now works routinely and according to plan.
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03 February 2010 /Authorisation and supervision
Compliance check of package leaflets and product labelling (winter 2009/2010)
In response to complaints and reports, etc. submitted to the Danish Patient Safety Database, the Danish Medicines Agency has examined different elements of the labelling of the below listed medicinal products to find out whether they comply with the provisions of the executive order on labelling
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29 January 2010 /Side effects and trials
Side effects from Pandemrix® from 9 to 22 January 2010
In the period from 9 to 22 January 2010, the Danish Medicines Agency received 28 new side effect reports covering a total of 63 suspected side effects (adverse reactions).
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29 January 2010 /Product information
Warning against pills from IDS Sports
The Danish Medicines Agency and the Danish Veterinary and Food Administration warn against use of the Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs and Ripped Tabs TR.
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27 January 2010 /Retail and online sale
Updated warning against counterfeit Alli® from the USA
In continuation of the Danish Medicines Agency's warning on 19 January 2010 against counterfeit versions of the weight-loss product Alli®, the Danish Medicines Agency would like to bring attention to the latest information on the counterfeit product.
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26 January 2010 /Authorisation and supervision
New practice for authorisation of contract acceptors on section 39 authorisations
On 1 February 2010, a new practice will apply to the authorisation of contract acceptors on authorisations granted pursuant to section 39 of the Danish Medicines Act (a section 39 authorisation).
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26 January 2010 /Prices and reimbursement
Change of the content of the fields ’Number of DDD per package’ and ’Price per DDD’
Users of ftp.dkma.dk, www.medicinpriser.dk and www.erhverv.medicinpriser.dk should note that the content of two fields in the LMS files at ftp.dkma.dk changed on 16 November 2009.
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26 January 2010 /News - miscellaneous
Vacancy for an Executive Director of the European Medicines Agency
The European Medicines Agency (EMA) is looking for an Executive Director to lead and manage the Agency and take overall responsibility for its operations, thus ensuring achievement of the Agency's objectives.
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22 January 2010 /Side effects and trials
European Medicines Agency recommends suspension of marketing authorisations for sibutramine due to increased risk of cardiovascular events
Sibutramine is a medicine used to promote weight loss, which has been marketed in Denmark since 2001 under the name Reductil®.
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19 January 2010 /Retail and online sale
Warning against counterfeit Alli® from the USA
The Danish Medicines Agency warns any consumers who have purchased the weight-loss product Alli® via American websites of the risk that the product may be counterfeit, and that the counterfeit version contains an active substance not listed on the package.
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15 January 2010 /Side effects and trials
Side effects from Pandemrix® from 19 December 2009 to 8 January 2010
In the period from 19 December 2009 to 8 January 2010, the Danish Medicines Agency received 32 new side effect reports covering a total of 73 suspected side effects (adverse reactions).
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08 January 2010 /Side effects and trials
Minutes of the Pharmacovigilance Working Party's meeting held on 21-23 September.
The Pharmacovigilance Working Party (PhVWP) under EMEA's Committee for Medicinal Products for Human Use (CHMP) held its September 2009 plenary meeting on 21-23 September 2009.
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07 January 2010 /Side effects and trials
Side effects from Eltroxin® - status January 2010
The Danish Medicines Agency has recorded an increase in the number of reported side effects from Eltroxin®. The increase is observed after the manufacturer changed the excipients contained in Eltroxin®.
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07 January 2010 /Prices and reimbursement
The Danish Medicines Agency initiates the reassessment of reimbursement status of medicines in ATC group N
The Danish Medicines Agency initiates its reassessment of the reimbursement status of medicines in ATC group N (Nervous system). It will take place concurrently with the reassessment process for the remaining subgroups in ATC groups A and J.
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04 January 2010 /Side effects and trials
Side effects from Pandemrix® from 12 to 18 December 2009
In the period from 12 to 18 December, the Danish Medicines Agency received 48 new side effect reports covering a total of 121 suspected side effects (adverse reactions).
