Bioequivalence and Bioavailability Forum • Promazine hydrochloride Pharmacokinetics

Promazine hydrochloride Pharmacokinetics [Design Issues]

posted by The Outlaw Torn – Europe, 2015-05-14 11:52 (2611 d 06:39 ago) – Posting: # 14814
Views: 8,615

» Promazine is available as a tablet in Croatia, Finland, Greece and Poland but as generic no innovator. In UK as a Sol.
» How can I find if any product is approved based on full dossier or is generic.

Hi pjs,

I really doubt any company would develop promazine based on a full dossier (I mean, what are the sales like?), but I could be wrong.

We've encountered a similar situation with another API that didn't have an originator on the EU market, and it was suggested to us following Scientific Advice from a northern European agency, whose country brews great beer, that we should submit as well established use.

Since there is no originator, it's unlikely you could convince an authority to accept a BCS-based biowaiver (lacking the dissolution comparison), but I could be wrong about that too. Good luck.

Complete thread:

Promazine hydrochloride Pharmacokinetics pjs 2015-05-13 05:45 [Design Issues]
- Promazine hydrochloride Pharmacokinetics pjs 2015-05-13 11:51
  - Promazine hydrochloride Pharmacokinetics nobody 2015-05-13 12:41
    - Promazine hydrochloride Pharmacokinetics pjs 2015-05-14 10:45
      - Promazine hydrochloride PharmacokineticsThe Outlaw Torn 2015-05-14 11:52
        
        Promazine hydrochloride Pharmacokinetics nobody 2015-05-14 13:25
        
        Promazine hydrochloride Pharmacokinetics The Outlaw Torn 2015-05-14 13:52
        
        Promazine hydrochloride Pharmacokinetics nobody 2015-05-14 14:33
        
        Promazine hydrochloride Pharmacokinetics pjs 2015-05-14 16:20
        
        Promazine hydrochloride Pharmacokinetics qualityassurance 2020-11-05 08:34