TruScient

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dibotermin alfa

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for TruScient has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 03/02/2015

Authorisation details

Product details
Name
TruScient
Agency product number
EMEA/V/C/002000
Active substance
dibotermin alfa
International non-proprietary name (INN) or common name
dibotermin alfa
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QM05BC01
Publication details
Marketing-authorisation holder
Zoetis Belgium SA
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
14/12/2011
Contact address

Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium

Product information

15/01/2015 TruScient - EMEA/V/C/002000 - IAIN/0005/G

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Bone morphogenetic proteins

Therapeutic indication

Osteoinductive agent for use in the treatment of long-bone fractures as an adjunct to standard surgical care using open fracture reduction in dogs.

Assessment history

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