Insulin Human Winthrop
Withdrawn
This medicine's authorisation has been withdrawn
insulin human
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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Report (EPAR) for Insulin Human Winthrop is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
N/0081
28/04/2016
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 diabetesTherapeutic 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.
This page was last updated on