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Patient safety, news and press releases from EMA

Fri, 17 May 2013 19:30:00 +0000: News and press releases: European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics – Patient safety, news and press releases: human and vet
Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Agency for the Safety of Medicine and Health Products (ANSM) unexpectedly announced today the decision to suspend the marketing authorisations of these medicines in France.
Fri, 17 May 2013 16:30:00 +0000: News and press releases: International Clinical Trials Day: 20 May 2013 – Patient safety, news and press releases: human and vet
The European Medicines Agency supports International Clinical Trials Day, which is taking place on Monday 20 May 2013.
Fri, 17 May 2013 14:00:00 +0000: News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2013 – Patient safety, news and press releases: human and vet
The Committee adopted by consensus a positive opinion for an initial marketing authorisation
application for ProZinc (insulin human) from Boehringer Ingelheim Vetmedica GmbH, for the
treatment of diabetes mellitus in cats to achieve reduction of hyperglycaemia and improvement of
associated clinical signs.
Fri, 17 May 2013 13:00:00 +0000: News and press releases: European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level – Patient safety, news and press releases: human and vet
The European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the marketing authorisation for Aftovaxpur DOE for use in response to outbreaks of foot-and-mouth disease (FMD).
Fri, 17 May 2013 11:00:00 +0000: News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013 – Patient safety, news and press releases: human and vet
European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg, ethinylestradiol 35 micrograms) and its generics outweigh the risks in a specific patient group, provided that several measures are taken to minimise the risk of thromboembolism, including new contraindications and warnings.

MedWatch Safety Alert RSS Feed

Sat, 18 May 2013 19:51:00 +0000: All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall – Lack Of Sterility Assurance – MedWatch Safety Alert RSS Feed
If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection.
Fri, 17 May 2013 19:55:00 +0000: Compounded Prescription Therapies By Pentec Health Inc.: Recall – Lack Of Sterility Assurance – MedWatch Safety Alert RSS Feed
Patients are at increased risk of infection in the event a sterile product is compromised.
Tue, 14 May 2013 14:30:00 +0000: Zolpidem Containing Products: Drug Safety Communication – FDA Requires Lower Recommended Doses – MedWatch Safety Alert RSS Feed
UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products.
Thu, 09 May 2013 20:00:00 +0000: Atriphen dietary supplement (Xymogen brand): Recall – Potential Allergic Reaction Due to Milk and Soy – MedWatch Safety Alert RSS Feed
Risk of serious or life-threatening allergic reaction.
Wed, 08 May 2013 21:45:00 +0000: The Compounding Shop: FDA News Release – Lack of Sterility Assurance of Drug Products – MedWatch Safety Alert RSS Feed
These products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.