This is a summary of the European public assessment report (EPAR) for NovoThirteen. 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 NovoThirteen.
Novothirteen : EPAR - Summary for the public (PDF/73.45 KB)
First published: 25/09/2012
Last updated: 25/03/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Blood Coagulation Disorders, Inherited
|Anatomical therapeutic chemical (ATC) code||
Novo Nordisk A/S
|Date of issue of marketing authorisation valid throughout the European Union||
24/05/2017 NovoThirteen - EMEA/H/C/002284 - R/0020
- 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
Please note that the size of the above document can exceed 50 pages.
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Long-term prophylactic treatment of bleeding in adult and paediatric patients 6 years and above with congenital factor-XIII-A-subunit deficiency.