Regulatory PathRegulatory requirements compared

Active substance

Dibotermin alfa

Open in the medicines table

EMA European Union — centrally authorised medicines

Inductos Medtronic BioPharma B.V. · Authorised · authorised 9 Sep 2002 · ATC M05BC01

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
INDUCTOS 1.5 MG/ML POWDER, SOLVENT AND MATRIX FOR IMPLANTATIONPLGB 43872/0001MEDTRONIC BIOPHARMA BVPOM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.