TruScient

Withdrawn

This medicine's authorisation has been withdrawn

dibotermin alfa

Overview

The marketing authorisation for TruScient has been withdrawn at the request of the marketing authorisation holder.

TruScient : EPAR - Summary for the public

Reference Number: EMA/848040/2011

Product information

TruScient : EPAR - Product Information

TruScient : EPAR - All Authorised presentations

Product details

• Name of medicine:
  TruScient
• Active substance:
  dibotermin alfa
• International non-proprietary name (INN) or common name:
  dibotermin alfa
• Species:
  Dogs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QM05BC01

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.

Authorisation details

• EMA product number:
  EMEA/V/C/002000
• Marketing authorisation holder:
  Zoetis Belgium SA

  Rue Laid Burniat 1; 1348 Louvain-la-Neuve; Belgium

• Marketing authorisation issued:
  14/12/2011
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

TruScient : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

TruScient : EPAR - Public assessment report

Adopted Reference Number: EMA/847913/2011

CVMP summary of positive opinion for TruScient

Adopted Reference Number: EMA/CVMP/648569/2011