Basic Information
Effentora
Regulatory Information
EMEA/H/C/000833
April 4, 2008
31
October 8, 2024
Company Information
the netherlands
Swensweg 5 2031GA Haarlem
Teva Pharma B.V.
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Effentora. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Effentora.