Regranex

RSS
Withdrawn

This medicine's authorisation has been withdrawn

becaplermin
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Regranex has been withdrawn at the request of the marketing-authorisation holder.

Regranex : EPAR - Summary for the public

English (EN) (291.69 KB - PDF)

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български (BG) (447.48 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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español (ES) (354.04 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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čeština (CS) (414.18 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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dansk (DA) (356.19 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Deutsch (DE) (357.22 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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eesti keel (ET) (349.88 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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ελληνικά (EL) (454.3 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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français (FR) (357.92 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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italiano (IT) (357.49 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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latviešu valoda (LV) (406.12 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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lietuvių kalba (LT) (384.62 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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magyar (HU) (407.98 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Malti (MT) (412.32 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Nederlands (NL) (354.56 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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polski (PL) (414.94 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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português (PT) (356.79 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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română (RO) (382.94 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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slovenčina (SK) (412.74 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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slovenščina (SL) (407.06 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Suomi (FI) (356.51 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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svenska (SV) (349.38 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Product information

Regranex : EPAR - Product Information

English (EN) (775.75 KB - PDF)

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български (BG) (854.61 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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español (ES) (429.44 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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čeština (CS) (646.87 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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dansk (DA) (429.78 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Deutsch (DE) (437.03 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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eesti keel (ET) (707.14 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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ελληνικά (EL) (886.04 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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français (FR) (497.39 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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íslenska (IS) (708.77 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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italiano (IT) (435.31 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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latviešu valoda (LV) (1.14 MB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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lietuvių kalba (LT) (751.74 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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magyar (HU) (640.61 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Malti (MT) (1.18 MB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Nederlands (NL) (703.73 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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norsk (NO) (713.55 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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polski (PL) (1.16 MB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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português (PT) (706.88 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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română (RO) (775.15 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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slovenčina (SK) (1.09 MB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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slovenščina (SL) (1.1 MB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Suomi (FI) (427.23 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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svenska (SV) (419.11 KB - PDF)

First published: 17/08/2009Last updated: 15/08/2012
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Latest procedure affecting product information: IB/0037/G
11/10/2010
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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

English (EN) (270.07 KB - PDF)

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български (BG) (326.45 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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español (ES) (268.13 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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čeština (CS) (264.2 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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dansk (DA) (280.29 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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Deutsch (DE) (272.38 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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eesti keel (ET) (227.33 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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ελληνικά (EL) (301.85 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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français (FR) (269.77 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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italiano (IT) (224.88 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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latviešu valoda (LV) (315.18 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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lietuvių kalba (LT) (291.46 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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magyar (HU) (297.51 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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Malti (MT) (310.49 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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Nederlands (NL) (268.8 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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polski (PL) (311.87 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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português (PT) (268.12 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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română (RO) (289.17 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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slovenčina (SK) (264.71 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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slovenščina (SL) (266.54 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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Suomi (FI) (268.3 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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svenska (SV) (269.98 KB - PDF)

First published: 21/10/2005Last updated: 15/08/2012
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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

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

English (EN) (362.13 KB - PDF)

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

AdoptedReference Number: EMA/585612/2010

English (EN) (544.97 KB - PDF)

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

English (EN) (315.98 KB - PDF)

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Regranex : EPAR - Procedural steps taken before authorisation

English (EN) (242.93 KB - PDF)

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Regranex : EPAR - Scientific Discussion

English (EN) (440.59 KB - PDF)

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More information on Regranex

Public statement on Regranex: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/495525/2012

English (EN) (77.16 KB - PDF)

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Questions and answers on the cessation of supply of Regranex (becaplermin)

Reference Number: EMA/CHMP/386043/2011

English (EN) (57.57 KB - PDF)

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Questions and answers on the review of Regranex (becaplermin)

Reference Number: EMA/312452/2009

English (EN) (62.54 KB - PDF)

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Regranex - Product information as approved by the CHMP on 18 February 2010, pending endorsement by the European Commission

English (EN) (249.27 KB - PDF)

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