Effentora (fentanyl)
- Region
- 🇪🇺 EU
- Active substance
- fentanyl
- Company
- Phoenix Labs Unlimited Company
- Status
- Authorised
- Therapeutic area
- Pain; Cancer
- EU approval
- Fri 04 Apr 2008
- Application
- EMEA/H/C/000833
- ATC
- N02AB03
- Official record
- www.ema.europa.eu
Indication
Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP 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 of 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
- 🇪🇺 Instanyl Authorised · Istituto Gentili S.r.l.
- 🇪🇺 PecFent Authorised · Gruenenthal GmbH
- 🇪🇺 Ionsys Withdrawn · Incline Therapeutics Europe Ltd
- 🇪🇺 Ionsys Withdrawn · Janssen-Cilag International NV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.