Insulin Human Winthrop

Withdrawn

This medicine's authorisation has been withdrawn

insulin human

Overview

On 11 January 2018 the European Commission withdrew the marketing authorisation for Insulin Human Winthrop (insulin human) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanofi-Aventis Deutschland GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Insulin Human Winthrop was granted marketing authorisation in the EU on 17 January 2007 for treatment of diabetes mellitus. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2011. Insulin Human Winthrop is an identical product to Insuman, which is authorised in the EU to treat diabetes mellitus. 

Insulin Human Winthrop was a duplicate application to Insuman, which is marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for Insuman. 

The European Public Assessment Report (EPAR) for Insulin Human Winthrop is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Insulin Human Winthrop : EPAR - Summary for the public

Product information

Insulin Human Winthrop : EPAR - Product Information

Insulin Human Winthrop : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Insulin Human Winthrop
• Active substance:
  insulin human
• International non-proprietary name (INN) or common name:
  insulin human
• Therapeutic area (MeSH):
  Diabetes Mellitus
• Anatomical therapeutic chemical (ATC) code:
  A10AB01

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000761
• Marketing authorisation holder:
  sanofi-aventis Deutschland GmbH

  Industriepark Höchst; D-65926 Frankfurt am Main; Germany

• Marketing authorisation issued:
  17/01/2007
• Withdrawal of marketing authorisation:
  11/01/2018
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Insulin Human Winthrop : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Insulin Human Winthrop : EPAR - Scientific Discussion

Insulin Human Winthrop : EPAR - Procedural steps taken before authorisation