This is a summary of the European public assessment report (EPAR) for Prometax. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prometax.
Prometax : EPAR - Summary for the public (PDF/79.75 KB)
First published: 16/06/2008
Last updated: 06/02/2013
Prometax : EPAR - Risk-management-plan summary (PDF/51.85 KB)
First published: 14/01/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
10/05/2021 Prometax - EMEA/H/C/000255 - IG1382/G
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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