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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.
