segunda-feira, abril 30, 2007

Novas bulas

Below are April '07 labelling changes and new information added to European Public Assessment Reports by EMEA/CHMP. Reports include updates to APV, INV, KAL, ATV, ETC, TDF. Click on the last (u) under EN. Note: click on (u on 8) Procedural steps taken and scientific information after authorisation for last updates.

European Public Assessment Reports (EPAR)
European Public Assessment Report (EPAR) - Backgrounder
Updated 16/04/07 CHMP revised EPARs on
Aptivus INN: tipranavir (Rev. 6)
INN: saquinavir (Rev. 21)
Kaletra INN: lopinavir (+Ritonavir) (Rev. 9)
Reyataz INN: atazanavir - (Rev. 6)
Updated 11/04/07 CHMP revised EPARs on:
Emtriva INN: emtricitabine (Rev. 6)
Viread INN: tenofovir disoproxil fumarate (Rev. 15)
11/04/07 EMEA Human Scientific Committees Working Party with Patients' and Consumers' Organisations(PCWP) Meeting Report from the December 2006 meeting
03/04/07 Procedure for Review of Information on Product by Patients'/ Consumers' Organisations

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