NovoThirteen

catridecacog

Table of contents

Opinion

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product NovoThirteen. The marketing authorisation holder for this medicinal product is Novo Nordisk A/S.

The CHMP adopted an extension to the existing indication as follows:1

Long term prophylaxisctic treatment of bleeding in patients with congenital factor XIII A-subunit deficiency. Treatment of breakthrough bleeding episodes during regular prophylaxis. NovoThirteen can be used for all age groups.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text shown in bold; removed text as strikethrough

Key facts

Name
NovoThirteen
Agency product number
EMEA/H/C/002284
International non-proprietary name (INN) or common name
  • catridecacog
Active substance
  • catridecacog
Therapeutic area
Blood Coagulation Disorders, Inherited
Date opinion adopted
23/07/2020
Company name
Novo Nordisk A/S
Status
Positive
Application type
Post-authorisation

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