EMEA-001762-PIP01-15 - paediatric investigation plan

hydromorphone (hydrochloride)

naloxone (hydrochloride)

Key facts

• Active substance:
  • hydromorphone (hydrochloride)
  • naloxone (hydrochloride)
• Therapeutic area:
  Pain
• Decision number:
  P/0223/2015
• PIP number:
  EMEA-001762-PIP01-15
• Pharmaceutical form(s):
  • Prolonged-release capsule
  • Capsule, hard
• Condition(s) / indication(s):
  • Treatment of opioid-induced constipation
  • Treatment of pain
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/10/2015
• Compliance check done:
  No

Decision

P/0223/2015: EMA decision of 2 October 2015 on the granting of a product specific waiver for hydromorphone (hydrochloride) / naloxone (hydrochloride) (EMEA-001762-PIP01-15)

Adopted Reference Number: EMA/603271/2015