🇪🇺 Human thrombin in European Union

EMA authorised Human thrombin on 23 October 2015

Marketing authorisations

EMA — authorised 23 October 2015

  • Application: EMEA/H/C/003914
  • Marketing authorisation holder: Instituto Grifols, S.A.
  • Local brand name: Veraseal
  • Indication: Supportive treatment for improvement of haemostasis and as a suture support in vascular surgery
  • Status: withdrawn

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EMA — authorised 10 November 2017

  • Application: EMEA/H/C/004446
  • Marketing authorisation holder: Instituto Grifols, S.A.
  • Local brand name: VeraSeal
  • Indication: Supportive treatment in adults where standard surgical techniques are insufficient: for improvement of haemostasis as suture support in vascular surgery
  • Status: approved

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Human thrombin in other countries

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

Frequently asked questions

Is Human thrombin approved in European Union?

Yes. EMA authorised it on 23 October 2015; EMA authorised it on 10 November 2017.

Who is the marketing authorisation holder for Human thrombin in European Union?

Instituto Grifols, S.A. holds the EU marketing authorisation.