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…

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…

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…

The marketing authorization holder informed its customers supplied with the product in a letter dated December 2, 2014, that all batches marketed had been reviewed because deviations had been identified in stability tests. For Austria, these tests…

Austria has been informed by the Italian Medicines Agency (AIFA) of a precautionary suspension of two batches (142701 and 143301) of the influenza vaccine Fluad. The reason for the suspension is the occurrence of serious adverse events that have been…

The distributor has informed its supplied customers in a letter dated 19.11.2014 that there is a possibility of crystallization (particle formation) in the injection solution of the above batch. The crystals observed are probably precipitated…

The marketing authorization holder informed its supplied customers in a letter dated October 21, 2014, that the affected finished product lot 4E915 was produced with an aciclovir active ingredient lot that does not meet the specifications regarding…

The Federal Office provides information on recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC) within the framework of the European risk assessment procedure according to Article 31 of Directive 2001/83/EC regarding the…

Status 06.09.2014: The BASG / AGES Medical Market Surveillance became aware that dubious persons were contacting by telephone in the name of AGES pharmaceutical companies, or that these persons were posing as AGES employees in order to request…

The distribution company informed its customers in a letter dated October 13, 2014, that after 3 years of storage at 30°C and 75% humidity and after 6 months of storage at 40°C and 75% humidity, increased levels of known and unknown impurities as…