The marketing authorization holder has informed its supplied customers that due to Commission Implementing Decision C(2014) 6030 of 19.08.2014 concerning marketing authorizations for medicinal products for human use for topical application with high concentrations of estradiol in accordance with Article 31 of Directive 2001/83/EC, the following…

Measures at EU level An inspection at the research service provider GVK Biosciences in Hyderabad (India) revealed serious deficiencies in the bioequivalence studies conducted there, which serve as the basis for the approval of generic drugs. Across Europe, more than 1,000 medicines were affected. The European Medicines Agency (EMA) has completed…

The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150115 a turbidity was detected and therefore a potential contamination had to be assumed.

Measures at EU level The EU Commission has released the emergency contraceptive "ellaOne" (active ingredient: Ulipristal) from prescription-only status. In doing so, the Brussels-based authority has followed the recommendation of the European Medicines Agency (EMA), which had come out in favor of a release in November. This decision applies to all…

The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150112 a turbidity was detected and therefore a potential contamination had to be assumed.

The marketing authorization holder informed its supplied customers in a letter dated January 13, 2015, that the package leaflet in Greek was enclosed with individual packages of batch 42053 and that a precautionary recall is therefore being carried out.

Isotretinoin is a highly effective vitamin A analogue that has been used since the early 1980s to treat severe, therapy-resistant forms of acne. When isotretinoin is taken during pregnancy, the risk of severe congenital malformations or spontaneous abortion is comparable to that after exposure to thalidomide. Isotretinoin is therefore absolutely…

The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosage) has been detected in dosing pumps in the prepackages of Axura 5 mg/pump stroke, 50 ml solution for oral use. Therefore, the affected batches are recalled by wholesalers, pharmacies as…

The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosing) has been detected in dosing pumps in the prepackages of Ebixa5 mg/pump hub, 50 ml solution for oral use. Therefore, the affected batches are recalled.

An inspection by the French Medicines Agency (ANSM) of the research service provider GVK Biosciences in Hyderabad (India) has revealed serious deficiencies in the conduct of bioequivalence studies for the approval of generic drugs. There is suspicion that relevant study parameters were deliberately falsified, which is a massive violation of Good…