TruScient

dibotermin alfa

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The marketing authorisation for TruScient has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
TruScient : EPAR - Summary for the public BG = bălgarski 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public ES = español 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public CS = čeština 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public DA = dansk 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public DE = Deutsch 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public ET = eesti keel 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public EL = elliniká 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public EN = English 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public FR = français 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public IT = italiano 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public LV = latviešu valoda 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public LT = lietuvių kalba 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public HU = magyar 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public MT = Malti 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public NL = Nederlands 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public PL = polski 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public PT = português 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public RO = română 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public SK = slovenčina 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public SL = slovenščina 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public FI = suomi 2011-12-20 2015-02-03
TruScient : EPAR - Summary for the public SV = svenska 2011-12-20 2015-02-03

This EPAR was last updated on 03/02/2015 .

Authorisation details

Product details

Product details for TruScient
NameTruScient
Agency product numberEMEA/V/C/002000
Active substance

dibotermin alfa

International non-proprietary name (INN) or common name

dibotermin alfa

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codeQM05BC01

Publication details

Publication details for TruScient
Marketing-authorisation holder

Zoetis Belgium SA

Revision4
Date of issue of marketing authorisation valid throughout the European Union14/12/2011

Contact address:

Zoetis Belgium SA
Rue Laid Burnait, 1
1348 Louvain-la-Neuve
Belgium

Product information

Product information

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

Name Language First published Last updated
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - Product Information SV = svenska 2011-12-20 2015-02-03

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03
TruScient : EPAR - All Authorised presentations SV = svenska 2011-12-20 2015-02-03

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

Changes since initial authorisation of medicine

Name Language First published Last updated
TruScient : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2012-02-23 2015-02-03

Initial marketing-authorisation documents

Name Language First published Last updated
TruScient : EPAR - Public assessment report SV = svenska 2011-12-20 2015-02-03
CVMP summary of positive opinion for TruScient SV = svenska 2011-10-14 2015-02-03