PRAC Member Comments on PRAC Rapporteur’s Reports

Vous devez toujours utiliser ce médicament en suivant scrupuleusement les informations fournies dans cette notice ou par votre médecin ou votre pharmacien.. - Gardez

The amount was recorded as deferred revenue at that time because the new Harmonized Sales Tax (HST) scheme was not to become effective until 1 April 1997. 2.28 As part of our

Afin de pouvoir le transmettre, nous vous recommandons de demander l’envoi de l’attestation par email. Après avoir terminé la formation, l’écran suivant

For DE/H/6160/001/DC, the proposed product name “TERIPARATIDE BIOGARAN 20 microgrammes / 80 microlitres, solution injectable en stylo prérempli” is acceptable in France.

In order to optimise national notifications, both French and English electronic versions of the final approved SPC, package leaflet and labelling in Word format / Template 10 should

1) The product name TERIWEL is not acceptable in France as it is too close to TORISEL from PFIZER EUROPE MA EEIG. 1 Please note that for 10.1 and 10.3 applications with a

 Free text comments or short comments can be sent to CHMP/CAT/PRAC using secure e-mail..  Use this template only if you wish to provide additional, more

We strongly support and recommend to have a combined DHPC (PRAC signal and Art. 31) in order to avoid multiple communications to HCPs at a short interval. Specific comments