Inductos

dibotermin alfa

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The marketing authorisation for Inductos has been suspended on the recommendation of the Agency’s Committee for Medicinal Products for Human Use (CHMP).

Name Language First published Last updated
Inductos : EPAR - Summary for the public BG = bălgarski 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public ES = español 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public CS = čeština 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public DA = dansk 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public DE = Deutsch 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public ET = eesti keel 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public EL = elliniká 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public EN = English 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public FR = français 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public IT = italiano 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public LV = latviešu valoda 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public LT = lietuvių kalba 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public HU = magyar 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public MT = Malti 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public NL = Nederlands 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public PL = polski 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public PT = português 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public RO = română 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public SK = slovenčina 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public SL = slovenščina 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public FI = suomi 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public SV = svenska 2008-08-15 2015-12-08
Inductos : EPAR - Summary for the public HR = Hrvatski 2008-08-15 2015-12-08

This EPAR was last updated on 08/12/2015 .

Authorisation details

Product details

Product details for Inductos
NameInductos
Agency product numberEMEA/H/C/000408
Active substance

dibotermin alfa

International non-proprietary name (INN) or common name

dibotermin alfa

Therapeutic area Tibial FracturesSpinal FusionFracture Fixation, Internal
Anatomical therapeutic chemical (ATC) code M05BC01

Publication details

Publication details for Inductos
Marketing-authorisation holder

Medtronic BioPharma B.V.

Revision20
Date of issue of marketing authorisation valid throughout the European Union09/09/2002

Contact address:

Medtronic BioPharma B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands

Product information

Product information

20/11/2015  Inductos -EMEA/H/C/000408 -A20/0082

Name Language First published Last updated
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08
Inductos : EPAR - Product Information HR = Hrvatski 2008-08-15 2015-12-08

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
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - All Authorised presentations HR = Hrvatski 2005-10-21 2015-12-08

Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Inductos is indicated for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non operative treatment for this condition.

Inductos is indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Inductos : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-10-21 2015-12-08
Inductos : EPAR - Scientific Discussion HR = Hrvatski 2005-10-21 2015-12-08

Suspended

This medicine is currently suspended for use in the European Union

More information on Inductos

Shortages