European Medicines Agency recommends restriction of use of Protelos/Osseor

The marketing authorization holder informed its supplied customers by letter dated February 03, 2014 that infusion bags of 0.9% NaCl 500ml Viaflo with Austrian presentation (Ch.No. 13H31E1A) were found in a carton of 0.9% NaCl 500ml Viaflo with…

The marketing authorization holder informed its supplied customers in a letter dated 31.01.2014 that a quality deviation with regard to product- and process-related impurities was found in stability tests for certain batches.

Prescription of CHCs and importance of individual risk factors.

Re-evaluation with regard to higher body weight or BMI

The marketing authorization holder informed its supplied customers in a letter dated 23.01.2014 that the batches listed show deviations in dissolution. The release of the active ingredient amitriptyline after four hours is slightly higher than…

Notified of 3 confirmed cases of Chikungunya virus.

1 B. Braun Austria Ges.m.b.H. informed its supplied customers by letter dated December 3, 2013, that precipitates were observed during the examination of reserve samples and that a precautionary recall is therefore being carried out. Henry Schein…

Other confirmed cases in the Caribbean islands.

The marketing authorization holder informed its supplied customers in a letter dated December 23, 2013, that it cannot be ruled out that a frequent occurrence of hypersensitivity reactions may occur with this batch and that a precautionary withdrawal…