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…

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…

The preparation Eldisin 5 mg dry ampoules (active ingredient: vindesine sulfate) has been approved in Austria since March 29, 1984. Vindesine is a cytostatic drug from the group of vinca alkaloids and has proven effective primarily in combination…

In a letter dated December 19, 2013, the marketing authorization holder informed its customers that an elevated level of a known degradation product of the active ingredient azithromycin has been detected in some vials and that a voluntary recall is…

WABOSAN Arzneimittelvertriebs GmbH has informed its supplied customers by letter dated 12.12.2013 that yellow-orange precipitations have been observed in batch Y260 in individual cases and therefore a precautionary recall is being carried out. This…