„Flying Team“ Pioglitazone – Expiry of data protection on 13.10.2010
updated: 2010.06.17
The BfArM will, from 13. Oktober 2010, accept generic applications for Pioglitazone 15 mg and 30 mg tablets. Taking into account the number of DCP submission requests already received, the BfArM has decided to open a further „Flying Team“ project aiming at shortened timelines for submission and evaluation.
Conditions
- Complete project data according to the provided table (
Pioglitazon Flying Team “FT” (file size: 48 KB))or according to the relevant HMA form by 31. July 2010 - Submission of complete dossiers within 3 weeks following the protection expiry - by 04.11.2010
- Product information identical with the centrally authorised originator Actos (DE and EN version)
(Applications with product information non identical with Actos will also be accepted but may not participate in the dedicated project due to extended timelines and additionally required resources for processing.)
Contact: pioglitazon@bfarm.de