Instanyl (fentanyl)
- Region
- 🇪🇺 EU
- Active substance
- fentanyl
- Company
- Istituto Gentili S.r.l.
- Status
- Authorised
- Therapeutic area
- Pain; Cancer
- EU approval
- Mon 20 Jul 2009
- Application
- EMEA/H/C/000959
- ATC
- N02AB03
- Official record
- www.ema.europa.eu
Indication
Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 PecFent Authorised · Gruenenthal GmbH
- 🇪🇺 Effentora Authorised · Phoenix Labs Unlimited Company
- 🇪🇺 Ionsys Withdrawn · Incline Therapeutics Europe Ltd
- 🇪🇺 Ionsys Withdrawn · Janssen-Cilag International NV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.