The marketing authorization holder informed its supplied customers in a letter dated August 27, 2012, that in the course of stability tests at the manufacturer Ben Venue Laboratories, Ohio, USA, an overfill was detected in a single dry-stone ampoule…

REQUIP 2 mg, comprime pellicule 1335798 1/24/13 Einstimmig Bescheid Zulassungsverlängerung national Carmubris - Trockenstechampulle mit Lösungsmittel 1-21762 Bristol-Myers Squibb GmbH 1335791 1/24/13 Einstimmig

Referenced at:

• BASG approval procedure