PAR not yet [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2011-10-21 18:02 (4949 d 01:12 ago) – Posting: # 7531
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Dear ElMaestro!

❝ ❝ One product (=one study) was approved by the German BfArM June this year (submitted May 2010).


❝ Do you have a link to a PAR for this product?


Not yet. If you go to PharmNet.Bund (in German only) > Recherche für Fachkreise > at the bottom of the new page ❝ akzeptieren » > Suche nach Attentin in Arzneimittelname. At the bottom ❝ los » > click on "Freie Infos" at the end, you will get a new page displaying
Pub. Assessment Report
(nicht vorhanden) = not existent
SmPC (in German) here.

So you have to believe me that the study was performed as mentioned above – until the product passes MRP. ;-)

This is a strange system anyway. I could not find PARs of other products (where Germany was the RMS) and the PAR is available e.g. at HMA.

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