Ionsys
Withdrawn
This medicine's authorisation has been withdrawn
fentanyl
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 27 September 2018 the European Commission withdrew the marketing authorisation for Ionsys (fentanyl) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Incline Therapeutics Europe Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Ionsys was granted marketing authorisation in the EU on 19 November 2015 for treatment of acute moderate to severe post-operative pain.
The European Public Assessment Report (EPAR) for Ionsys is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:--
26/10/2018
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
Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Assessment history
News on Ionsys
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