|
bioequa ☆ Bosnia and Herzegovina, 2011-02-02 16:28 (5627 d 00:13 ago) Posting: # 6544 Views: 3,460 |
|
|
hello, my question is about carbocystein (carbocisteine). Long time ago we used MUCOPRONT 375 mg capsules (carbocisteine), by Heinrich Mack Nachf. GmbH & Co (Germany) as reference drug in bioequivalence study. Heinrich Mack is part of Pfizer now. Mucopront was withdrawn 22-Jul-2005. Selection of MUCOPRONT capsules as reference drug is in question now by regulatory agency. I couldn't find any information about first marketing authorization date of MUCOPRONT capsule by Heinrich MACK, or was it authorized as reference drug in Germany according to full preclinical and clinical data? I tried to contact Bfarm, by sending a milion of e-mails, but nobody answers! Please, provide any help. |
