Regranex

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becaplermin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Regranex has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 15/08/2012

Authorisation details

Product details
Name
Regranex
Agency product number
EMEA/H/C/000212
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
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
29/03/1999
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

11/10/2010 Regranex - EMEA/H/C/000212 - IB/0037/G

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Preparations for treatment of wounds and ulcers

Therapeutic 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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