Ionsys
Withdrawn
This medicine's authorisation has been withdrawn
fentanyl
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 24 January 2006 the European Commission granted a marketing authorisation for the whole European Union to Janssen-Cilag International N.V. for Ionsys (fentanyl), a iontophoretic transdermal system to deliver fentanyl transdermally, to be used for the management of acute moderate to severe post-operative pain for use in a hospital setting only. In January 2009 the European Commission issued a decision for suspension of the marketing authorization of Ionsys for quality related issues.
Ionsys has not been marketed in Europe since October 2008. The Marketing Authorisation Holder did not apply to renew the marketing authorisation. Consequently, the five-year marketing authorization for Ionsys expired on 24 January 2011.
Pursuant to this decision the European Public Assessment Report for Ionsys is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
A20-0013
24/01/2011
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
- Ionsys
- Active substance
- fentanyl hydrochloride
- International non-proprietary name (INN) or common name
- fentanyl
- Therapeutic area (MeSH)
- Pain, Postoperative
- Anatomical therapeutic chemical (ATC) code
- N02AB03
Pharmacotherapeutic group
AnalgesicsTherapeutic indication
Management of acute moderate to severe post-operative pain for use in a hospital setting only
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