Riprazo
Withdrawn
This medicine's authorisation has been withdrawn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 Riprazo, (aliskiren), which had been approved for treatment of essential hypertension. The marketing authorisation holder (MAH) responsible for Riprazo was Novartis Europharm Ltd.
On 24 January 2013, the European Commission issued a decision to withdraw the marketing authorisation for Riprazo, following its receipt of a letter dated 18 December 2012 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. Riprazo was marketed in the following European countries: Spain (until 31 December 2012) and was not marketed in any other European country.
Pursuant to this decision, the European public assessment report for Riprazo is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IG/0209/G
17/08/2012
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
- Riprazo
- 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.
News on Riprazo
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