EMEA-001567-PIP01-13-M03 - paediatric investigation plan

naloxone (hydrochloride)

Key facts

• Active Substance:
  naloxone (hydrochloride)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0146/2018
• PIP number:
  EMEA-001567-PIP01-13-M03
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Age-appropriate dosage form, other
• Condition(s) / indication(s):
  Treatment of opioid-induced constipation
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Develco Pharma GmbH

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/05/2018

Decision

P/0146/2018: EMA decision of 7 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for naloxone (hydrochloride), (EMEA-001567-PIP01-13-M03)

AdoptedReference Number: EMA/259091/2018