Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: TruScient   
Auth. number : EU/2/11/136
INN : Dibotermin alfa
ATC: Anatomical main group: QM - Musculo-skeletal system
Therapeutic subgroup: QM05 - Drugs for treatment of bone diseases
Pharmacological subgroup: QM05B - Drugs affecting bone structure and mineralization
Chemical subgroup: QM05BC - Bone morphogenetic proteins
Chemical substance: QM05BC01 - Dibotermin alfa
(See WHO ATCvet Index)
Indication: Treatment of diaphyseal fractures as an adjunct to standard surgical care using open fracture reduction in dogs.
Marketing Authorisation Holder: Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/12/2011 Centralised - Authorisation EMEA/V/C/2000 (2011)9732 of 14/12/2011
14/02/2012 Centralised - Variation EMEA/V/C/2000/IA/1
Updated with Decision(2012)6386 of 10/09/2012
12/09/2012 Centralised - Variation (2012)6386 of 10/09/2012
27/05/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/V/C/2000/T/2 (2013)3153 of 23/05/2013
25/06/2013 Centralised - Variation EMEA/V/C/2000/IB/3
Updated with Decision(2014)4589 of 30/06/2014
05/09/2013 Centralised - Variation EMEA/V/C/2000/IA/5
Updated with Decision(2014)4589 of 30/06/2014
02/07/2014 Centralised - Yearly update (2014)4589 of 30/06/2014