Regranex

Withdrawn

This medicine's authorisation has been withdrawn

becaplermin

Overview

The marketing authorisation for Regranex has been withdrawn at the request of the marketing-authorisation holder.

Regranex : EPAR - Summary for the public

Product information

Regranex : EPAR - 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).

Regranex : EPAR - All Authorised presentations

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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000212
• Marketing authorisation holder:
  Janssen-Cilag International NV

  Turnhoutseweg, 30; B-2340 Beerse; Belgium

• Marketing authorisation issued:
  29/03/1999
• Revision:
  18

Assessment history

Changes since initial authorisation of medicine

Regranex : EPAR - Procedural steps taken and scientific information after authorisation

Regranex-H-C-212-A20-33 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/585612/2010

Regranex : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Regranex : EPAR - Procedural steps taken before authorisation

Regranex : EPAR - Scientific Discussion