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29 February 2012 /Authorisation and supervision
Compliance check of package leaflets and product labelling (winter 2012)
Companies marketing medicines in Denmark are responsible for ensuring that their package leaflets and labelling comply with the Danish executive order on labelling. The Danish Medicines Agency regularly carries out random compliance checks of package leaflets and product labelling.
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28 February 2012 /Side effects and trials
Delay in ACKs for adverse reaction reports due to IT maintenance
EMA is performing maintenance of the EudraVigilance database, including the gateway, from 29 February 2012 to 5 March 2012. There will therefore be a delay in the dispatch of acknowledgement messages (ACKs) for adverse reaction reports.
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27 February 2012 /About us
CVR, EAN and bank details after 1 March 2012
The Danish National Board of Health and the Danish Medicines Agency merge on 1 March 2012 to form a new Danish National Board of Health. Suppliers and contractors, etc. that do business with the Danish National Board of Health or the Danish Medicines Agency are to continue using the provided CVR, EAN and bank details until the organisational changes have been fully implemented.
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27 February 2012 /Retail and online sale
Record number of illegal drug imports in Denmark in 2011 – erectile dysfunction drugs represent one third
In 2011, the Danish Medicines Agency together with Post Danmark and SKAT (the Danish tax authorities) retained altogether 8,174 parcels with illegally imported medicines whose actual content is often unknown. This is almost twice as many as in 2010, and around one third of the parcels contained erectile dysfunction drugs.
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24 February 2012 /News - miscellaneous
Changed opening hours on 29 February and 1 March
In connection with the merger with the Danish National Board of Health, the Danish Medicines Agency will be closed on 29 February until 12:00 noon.On Thursday 1 March, the reception and main entrance at Axel Heides Gade will be closed until 11:30.
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24 February 2012 /Side effects and trials
The Danish Medicines Agency publishes prints of reported side effects for download
The Danish Medicines Agency has just published its first complete prints of suspected adverse drug reactions from medicines that doctors, patients and others have reported. To begin with, we provide access to the adverse drug reactions reported for 13 selected active substances.
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23 February 2012 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances theophylline, theophylline-ethylenediamine anhydrous and caffeine
The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificates of Suitability (CEP) for a number of active substances.
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23 February 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – February 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 13-15 February 2012. Among the topics discussed at the meeting were Docetaxel actavis and Good Pharmacovigilance Practices (GVP) for the EU.
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22 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of escitalopram
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for escitalopram-containing medicines.The Danish Medicines Agency has now translated this recommendation into Danish.
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21 February 2012 | Updated 22 February 2012 /Prices and reimbursement
Decision on general conditional reimbursement for alendronate-containing medicines
In cooperation with the Reimbursement Committee, we have decided to grant alendronate-containing medicines general conditional reimbursement from 5 March 2012. Reimbursement is conditional as it is reserved for patients with low-energy hip fractures. For any other patients who are treated with alendronate, the doctor must apply for single reimbursement, and the guiding criteria for single reimbursement remain unchanged for these patients. Alendronate is used for the treatment of osteoporosis (brittle bones).
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21 February 2012 | Updated 22 February 2012 /Prices and reimbursement
Changed criteria for single reimbursement for osteoporosis medicines other than alendronate
As of 5 March 2012, it will only be possible to obtain a single reimbursement grant for the other medicines used in osteoporosis treatment for patients that cannot use alendronate. The criteria for single reimbursement are changed because of the large price gaps between the different medicines, where the reimbursement price of alendronate is by far the lowest.
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21 February 2012 /Authorisation and supervision
Romanian wholesale dealer has used forged authorisation
The Romanian authorities warn against a company which has used a forged wholesale dealer's authorisation to trade with other European companies. The company concerned is:INTER PHARMA GOLD SRL.
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20 February 2012 | Updated 21 February 2012 /Side effects and trials
New contraindications and warnings for blood pressure medicines with the substance aliskiren
The European Medicines Agency, EMA, has just finalised a review of the benefits and risks of blood pressure medicines with aliskiren. The review has resulted in new contraindications and warnings for these medicines.
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17 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of gonadotropin-releasing hormone agonists
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for gonadotropin-releasing hormone agonists (buserelin, goserelin, histrelin, leuprorelin, nafarelin, triptorelin). The Danish Medicines Agency has now translated this recommendation into Danish.
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17 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of methotrexate
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for methotrexate. The text is used to prepare new product information for medicines with methotrexate.
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17 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of HMG-CoA reductase inhibitors (statins)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for HMG-CoA reductase inhibitors. The Danish Medicines Agency has now translated this recommendation into Danish.
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17 February 2012 /Retail and online sale
Counterfeit Avastin is not distributed in Denmark
On Tuesday 14 February, the FDA warned against using Avastin 25 mg/ml. The counterfeit Avastin is not distributed in Denmark.
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15 February 2012 /Authorisation and supervision
DCP time slots for the period July-October 2012 still available
From 13 February until 27 February 2012, the Danish Medicines Agency accepts request for DCP time slots with Denmark as reference member state (RMS) for the period July-October 2012.
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08 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of tibolone (Livial)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for tibolone-containing medicines. The Danish Medicines Agency has now translated this recommendation into Danish.
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07 February 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance trimetazidine dihydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): CEP R0-2007-254-Rev01 trimetazidine dihydrochloride.
