Regranex
Withdrawn
This medicine's authorisation has been withdrawn
becaplermin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On the 29 March 1999 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Regranex (becaplermin), which had been approved, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2 . The marketing authorisation holder (MAH) responsible for Regranex was Janssen-Cilag International NV.
The European Commission was notified by a letter dated 20 June 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Regranex for commercial reasons. Regranex was marketed in France, Ireland, Germany, Netherlands, Sweden, Spain and UK.
On 16 July 2012 the European Commission issued a decision to withdraw the marketing authorisation for Regranex. Pursuant to this decision the European Public Assessment Report for Regranex is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IB/0037/G
11/10/2010
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Regranex
- Active substance
- becaplermin
- International non-proprietary name (INN) or common name
- becaplermin
- Therapeutic area (MeSH)
- Wound Healing
- Skin Ulcer
- Anatomical therapeutic chemical (ATC) code
- D03AX06
Pharmacotherapeutic group
Preparations for treatment of wounds and ulcersTherapeutic indication
Regranex is indicated, in association with other good wound care measures, to promote granulation and thereby the healing of full-thickness, neuropathic, chronic, diabetic ulcers less than or equal to 5 cm2.
Assessment history
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