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30 April 2012 /Authorisation and supervision
Submission of package leaflets and product labelling in connection with parallel import
The Danish Health and Medicines Authority reminds companies submitting parallel import applications to enclose the package leaflet and labelling on an A4 sheet in a readable font size. The font size used must be size 11 or more.
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24 April 2012 /Authorisation and supervision
The EDQM has withdrawn the Certificate of Suitability for the active substance Acetylsalicylic acid
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2006-195-Rev 00 / Acetylsalicylic acid.
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24 April 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance Stanozolol Micronised
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): R1-CEP 2002-222-Rev 01 / Stanozolol Micronised.
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24 April 2012 /Authorisation and supervision
The EDQM has withdrawn the Certificate of Suitability for the active substance Oxaliplatin
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2005-158-Rev 00 / Oxaliplatin.
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18 April 2012 /Authorisation and supervision
The EDQM has withdrawn Certificates of Suitability for the active substance Diclofenac Sodium
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): R0-CEP 2006-304-Rev 00 Diclofenac Sodium and R1-CEP 2000-133-Rev 02 Diclofenac Sodium.
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17 April 2012 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information – proton-pump inhibitors' class effects on magnesium blood levels from long-term use
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information concerning the class effects of proton-pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole) on magnesium blood levels from long-term use.
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17 April 2012 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information – prescription-only proton-pump inhibitors and risk of fractures of the hip, wrist and spine
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for prescription-only proton-pump inhibitors (omeprazole esomeprazole/naproxen, omeprazole/ketoprofen, esomeprazole, lansoprazole, pantoprazole, rabeprazole) and risk of fractures of the hip, wrist and spine.
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17 April 2012 /Authorisation and supervision
The EDQM has withdrawn Certificates of Suitability from CSPC Innovation Pharmaceutical Co., Ltd.
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn a number of Certificates of Suitability (CEP) from CSPC Innovation Pharmaceutical Co., Ltd.
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11 April 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of topiramate
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for topiramate-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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11 April 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 Certificates of Suitability (CEP): RO-CEP 2007-245-Rev 01 Trimetazidine dihydrochloride.
