Enquete sur les effets indesirables du tetrazepam

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Enquête!sur!les!effets!indésirables!du!tétrazépam!
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Commission!nationale!de!pharmacovigilance,!20!novembre!2012!
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Centre!!régional!!de!!pharmacovigilance!!de!!Bordeaux!
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Résumé!
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Méthodes)
4.(;3,$! 1$,! =(,! .0%2B2&,! 1(.,! ;(! /(,$! .(%20.(;$! 1$! *>('+(=0M2?2;(.=$:! 1$,! =(,! .0%2B2&,! (-A!
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Résultats)
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Conclusion)
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1.!Rappels!
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Médicaments)ayant)une)AMM)et)médicaments)commercialisés))
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!
Nom!! Laboratoire! Date!AMM!
Mégavix®! Sanofi! 07/11/1994!
(archivée!;! arrêt! commercialisation! juillet!
2005)!
Myolastan®!(princeps)!
Sanofi!!
03/05/1967!
Panos®!
Daiichi!Sankyo!France!
21/12/1994!
Tétrazépam!Almus1!
Almus!
05/05/2003!
Tétrazépam!Arrow1!!
Arrow!(titulaire,!AMM!;!!Almus!
(exploitant)!
17/07/2001!
Tétrazépam!Biogaran!!
Biogaran!
20/10/1999!
Tétrazépam!Cristers!
Cristers!
26/07/2000!
Tétrazépam!EG!
EG!Labo!(Eurogenerics)!
02/07/2001!
Tétrazépam!G!Gam!
Sandoz!
26/07/2000!
(archivée!;! arrêt! commercialisation!
septembre!2006!bte!20,!juillet!2006!bte!50)!
Tétrazépam!Mylan!
Mylan!SAS!
12/02/1998!
Tétrazépam!Qualimed!
Qualimed!
03/07/2001!
Tétrazépam!Ratiopharm2!!
Ratiopharm!
28/12/1999!
Tétrazépam!RPG!
Ranbaxy!
26/07/2000!!
Tétrazépam!Sandoz!
Sandoz!!
22/12/1999!
Tétrazépam!Teva2!
Teva!Santé!
03/05/2000!
Tétrazépam!Zentiva3!!
Sanofi!!
11/06/2003!
Tétrazépam!Zydus!
Zydus!
11/02/!2000!
Tableau!I.!AMM!de!tétrazépam!en!France!
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

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P!
Pharmacologie)
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2.!Données!de!notification!spontanée!
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