Zalviso
Withdrawn
This medicine's authorisation has been withdrawn
sufentanil
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 5 August 2022, the European Commission withdrew the marketing authorisation for Zalviso (sufentanil) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, FGK Representative Service GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Zalviso was granted marketing authorisation in the EU on 18 September 2015 for the management of acute moderate to severe post-operative pain. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2020.
The European Public Assessment Report (EPAR) for Zalviso is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:T/0017
05/08/2022
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
- Zalviso
- Active substance
- sufentanil
- International non-proprietary name (INN) or common name
- sufentanil
- Therapeutic area (MeSH)
- Pain, Postoperative
- Anatomical therapeutic chemical (ATC) code
- N01AH03
Pharmacotherapeutic group
AnestheticsTherapeutic indication
Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.
News on Zalviso
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