PecFent (fentanyl)
- Region
- 🇪🇺 EU
- Active substance
- fentanyl
- Company
- Gruenenthal GmbH
- Status
- Authorised
- Therapeutic area
- Pain; Cancer
- EU approval
- Tue 31 Aug 2010
- Application
- EMEA/H/C/001164
- ATC
- N02AB03
- Official record
- www.ema.europa.eu
Indication
PecFent is indicated for the management of breakthrough pain in adults who are 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 of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic 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.
- 🇪🇺 Effentora Authorised · Phoenix Labs Unlimited Company
- 🇪🇺 Ionsys Withdrawn · Incline Therapeutics Europe Ltd
- 🇪🇺 Ionsys Withdrawn · Janssen-Cilag International NV
Follow PecFent
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.