Overview
The marketing authorisation for Replixa has been withdrawn at the request of the marketing authorisation holder.
Product information
Latest procedure affecting product information: IB/0021/G
19/03/2018
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Raplixa
- Active substance
- human fibrinogen
- human thrombin
- International non-proprietary name (INN) or common name
- human fibrinogen
- human thrombin
- Therapeutic area (MeSH)
- Hemostasis, Surgical
- Anatomical therapeutic chemical (ATC) code
- B02BC30
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic indication
Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.
Raplixa must be used in combination with an approved gelatin sponge.
Raplixa is indicated in adults over 18 years of age.
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