Ionsys (fentanyl)
- Region
- 🇪🇺 EU
- Active substance
- fentanyl
- Company
- Incline Therapeutics Europe Ltd
- Status
- Withdrawn
- Therapeutic area
- Pain, Postoperative
- CHMP opinion
- Wed 23 Sep 2015
- EU approval
- Wed 18 Nov 2015
- Application
- EMEA/H/C/002715
- ATC
- N02AB03
- Official record
- www.ema.europa.eu
Indication
Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Instanyl Authorised · Istituto Gentili S.r.l.
- 🇪🇺 PecFent Authorised · Gruenenthal GmbH
- 🇪🇺 Effentora Authorised · Phoenix Labs Unlimited Company
- 🇪🇺 Ionsys Withdrawn · Janssen-Cilag International NV
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.