Inductos

RSS

dibotermin alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Inductos. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Inductos.

This EPAR was last updated on 18/09/2018

Authorisation details

Product details
Name
Inductos
Agency product number
EMEA/H/C/000408
Active substance
dibotermin alfa
International non-proprietary name (INN) or common name
dibotermin alfa
Therapeutic area (MeSH)
  • Tibial Fractures
  • Fracture Fixation, Internal
  • Spinal Fusion
Anatomical therapeutic chemical (ATC) code
M05BC01
Publication details
Marketing-authorisation holder
Medtronic BioPharma B.V.
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
09/09/2002
Contact address
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands

Product information

17/08/2018 Inductos - EMEA/H/C/000408 - IA/0090

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.

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

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