🇪🇺 Regranex in European Union

EMA authorised Regranex on 29 March 1999

Marketing authorisations

EMA — authorised 29 March 1999

  • Application: EMEA/H/C/000212
  • Marketing authorisation holder: Janssen-Cilag International NV
  • Local brand name: Regranex
  • 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.
  • Status: withdrawn

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EMA — authorised 20 November 2009

  • Application: EMEA/H/C/000997
  • Marketing authorisation holder: BioMimetic Therapeutics Ltd
  • Local brand name: Gemesis
  • Status: rejected

Read official source →

Regranex in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in European Union

Frequently asked questions

Is Regranex approved in European Union?

Yes. EMA authorised it on 29 March 1999; EMA authorised it on 20 November 2009.

Who is the marketing authorisation holder for Regranex in European Union?

Janssen-Cilag International NV holds the EU marketing authorisation.