Insulin Human Winthrop


insulin human

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Ablavar has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 30/04/2018

Authorisation details

Product details
Insulin Human Winthrop
Agency product number
Active substance
insulin human
International non-proprietary name (INN) or common name
insulin human
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
sanofi-aventis Deutschland GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Industriepark Höchst
D-65926 Frankfurt am Main

Product information

28/04/2016 Insulin Human Winthrop - EMEA/H/C/000761 - N/0081


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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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.

Assessment history

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