Enviage
Withdrawn
This medicine's authorisation has been withdrawn
aliskiren
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 22 August 2007 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Enviage (aliskiren). Enviage is approved for the treatment of essential hypertension. The marketing authorisation holder (MAH) responsible for Enviage was Novartis Europharm Ltd. The European Commission was notified by letter dated 4 May 2010 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Enviage for commercial reasons.
As of 4 May 2010, Enviage has not been marketed anywhere in the European Union and there is no intention to market Enviage in the future. Enviage was an additional application to Rasilez, intended for co-marketing purposes. The MAH will maintain the Marketing Authorisations for the three other medicinal products containing aliskiren, i.e. Rasilez, Riprazo and Sprimeo.
On 27 September 2010 the European Commission issued a decision to withdraw the marketing authorisation for Enviage.
Pursuant to this decision the European Public Assessment Report for Enviage is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
II/0034
22/04/2009
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
- Enviage
- Active substance
- aliskiren
- International non-proprietary name (INN) or common name
- aliskiren
- Therapeutic area (MeSH)
- Hypertension
- Anatomical therapeutic chemical (ATC) code
- C09XA02
Pharmacotherapeutic group
Agents acting on the renin-angiotensin systemTherapeutic indication
Treatment of essential hypertension
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