The marketing authorization holder has informed its supplied customers in a letter dated April 15, 2016, that a possible non-sterility cannot be excluded and therefore a precautionary recall is being carried out. This recall results from an…

In a letter dated April 13, 2016, the marketing authorization holder informed its customers that the above-mentioned batch of "Curatoderm - Ointment" was found to be mixed with "Amciderm - Cream" and is therefore being recalled. "Amciderm - Creme" is…

Due to legal requirements (Reg. (EC) 726/2004, Article 25a), EMA is obliged to set up a database for periodic safety update reports (PSUR) and the associated opinions. All PSUR procedures must be submitted electronically (according to Reg. 726/2004,…

The pharmaceutical company "Amomed Pharma GmbH" has informed its supplied customers by letter dated 11.03.2016 that in the course of stability testing a clear brown coloration of the solution was detected in some ampoules. This brown coloration…

From 1 January 2007 to 23 March 2016, Zikavirus transmission was documented in a total of 61 countries and territories. Four of these countries and territories reported a Zika virus outbreak that is now over.

Recently, pyrrolizidine alkaloids have also been detected in herbal preparations made from plants that do not biosynthesize pyrrolizidine alkaloids. Studies suggest that contamination with weeds may be responsible. Since even very few individuals of…

At the European Medicines Agency (EMA) Management Board meeting in London on March 17, 2016, Christa Wirthumer-Hoche was elected Chair of the EMA Management Board for a three-year term. DI Dr. Wirthumer-Hoche is Head of AGES Medical Market…

Agepha Pharma has informed its customers in a letter dated 24.02.2016 about the recall of the mentioned batch for the following reason: The composition of the eye drops has been changed (addition of povidone), but the official assessment of this…

The company B. Braun Austria Ges.m.b.H. informed its supplied customers in a letter dated 28.01.2016 that due to customer complaints about leaking Ecoflac® plus infusion containers of the mentioned batch a precautionary recall due to possible leakage…

A Rapid Risk Assessment from the European Centre for Disease Prevention and Control (ECDC) regarding the ZIKA virus epidemic was forwarded to the Federal Office for Safety in Health Care by the European Commission and can be found in the appendix.