Velosulin
Withdrawn
This medicine's authorisation has been withdrawn
insulin human (rDNA)
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 7 October 2002, the European Commission granted a marketing authorisation valid throughout the European Union for the medicinal product Velosulin (insulin human) 10ml (3.5 mg/ml) for subcutaneous or intravenous use, indicated for the treatment of diabetes mellitus.
On 18 December 2008, the marketing authorisation holder (MAH) responsible for Velosulin, Novo Nordisk A/S, notified the European Commission of its decision to voluntarily withdraw its marketing authorisation for commercial reasons.
On 30 January 2009, the European Commission issued a decision to withdraw the marketing authorisation for Velosulin. Pursuant to this decision, the European Public Assessment Report for Velosulin is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:N/0007
16/03/2008
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
- Velosulin
- Active substance
- Insulin human
- International non-proprietary name (INN) or common name
- insulin human (rDNA)
- Therapeutic area (MeSH)
- Diabetes Mellitus
- Anatomical therapeutic chemical (ATC) code
- A10AB01
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Treatment of diabetes mellitus.
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