This is a summary of the European public assessment report (EPAR) for Orfadin. 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 Orfadin.
Orfadin : EPAR - Summary for the public (PDF/75.67 KB)
First published: 10/11/2009
Last updated: 23/07/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Swedish Orphan Biovitrum International AB
|Date of issue of marketing authorisation valid throughout the European Union||
20/11/2018 Orfadin - EMEA/H/C/000555 - PSUSA/00002169/201802
- 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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