Insulin Human Winthrop

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insulin human

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Ablavar has been withdrawn at the request of the marketing authorisation holder.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
Name
Insulin Human Winthrop
Agency product number
EMEA/H/C/000761
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
Publication details
Marketing-authorisation holder
sanofi-aventis Deutschland GmbH
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
17/01/2007
Contact address
Industriepark Höchst
D-65926 Frankfurt am Main
Germany

Product information

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

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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