🇪🇺 INSULIN HUMAN in European Union

EMA authorised INSULIN HUMAN on 21 February 1997

Marketing authorisations

EMA — authorised 21 February 1997

  • Application: EMEA/H/C/000201
  • Marketing authorisation holder: Sanofi-aventis Deutschland GmbH
  • Local brand name: Insuman
  • Indication: Diabetes mellitus where treatment with insulin is required. Insuman Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.
  • Status: approved

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EMA — authorised 7 October 2002

  • Application: EMEA/H/C/000423
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Velosulin
  • Indication: Treatment of diabetes mellitus.
  • Status: withdrawn

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EMA — authorised 7 October 2002

  • Application: EMEA/H/C/000427
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Actraphane
  • Indication: Treatment of diabetes mellitus.
  • Status: approved

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EMA — authorised 7 October 2002

  • Application: EMEA/H/C/000439
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Ultratard
  • Indication: Treatment of diabetes mellitus.
  • Status: withdrawn

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EMA — authorised 7 October 2002

  • Application: EMEA/H/C/000440
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Monotard
  • Indication: Treatment of diabetes mellitus.
  • Status: withdrawn

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EMA — authorised 17 January 2007

  • Application: EMEA/H/C/000761
  • Marketing authorisation holder: sanofi-aventis Deutschland GmbH
  • Local brand name: Insulin Human Winthrop
  • Indication: Diabetes mellitus where treatment with insulin is required. Insulin Human Winthrop Rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.
  • Status: withdrawn

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EMA — authorised 31 December 2009

  • Application: EMEA/H/C/000847
  • Marketing authorisation holder: Marvel LifeSciences Ltd.
  • Local brand name: Insulin Human 30/70 Mix Marvel
  • Status: withdrawn

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EMA — authorised 31 December 2009

  • Application: EMEA/H/C/000845
  • Marketing authorisation holder: Marvel LifeSciences Ltd.
  • Local brand name: Insulin Human Rapid Marvel
  • Status: withdrawn

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EMA — authorised 31 December 2009

  • Application: EMEA/H/C/000846
  • Marketing authorisation holder: Marvel LifeSciences Ltd.
  • Local brand name: Insulin Human Long Marvel
  • Status: withdrawn

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EMA — authorised 14 December 2012

  • Application: EMEA/H/C/002609
  • Marketing authorisation holder: Marvel Life Sciences Ltd.
  • Local brand name: Combimarv
  • Indication: Treatment of diabetes mellitus
  • Status: withdrawn

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EMA — authorised 14 December 2012

  • Application: EMEA/H/C/002610
  • Marketing authorisation holder: Marvel Life Sciences Ltd.
  • Local brand name: Isomarv medium
  • Indication: treatment of diabetes mellitus
  • Status: withdrawn

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EMA — authorised 14 December 2012

  • Application: EMEA/H/C/002506
  • Marketing authorisation holder: Marvel Life Sciences Ltd.
  • Local brand name: Solumarv
  • Indication: treatment of diabetes mellitus
  • Status: withdrawn

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EMA — authorised 11 February 2016

  • Application: EMEA/H/C/003858
  • Marketing authorisation holder: Marvel Lifesciences Ltd
  • Local brand name: Solumarv
  • Indication: Treatment of diabetes
  • Pathway: biosimilar
  • Status: rejected

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EMA

  • Application: EMEA/H/C/006011
  • Marketing authorisation holder: Rechon Life Science AB
  • Local brand name: Insulin Human Rechon
  • Indication: Treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis
  • Pathway: biosimilar
  • Status: withdrawn

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INSULIN HUMAN 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 INSULIN HUMAN approved in European Union?

Yes. EMA authorised it on 21 February 1997; EMA authorised it on 7 October 2002; EMA authorised it on 7 October 2002.

Who is the marketing authorisation holder for INSULIN HUMAN in European Union?

Sanofi-aventis Deutschland GmbH holds the EU marketing authorisation.