EMEA-002877-PIP01-20 - paediatric investigation plan

nefopam (hydrochloride)

paracetamol

Key facts

• Invented name:
  METAPAIN
• Active Substance:
  • nefopam (hydrochloride)
  • paracetamol
• Therapeutic area:
  Pain
• Decision number:
  P/0055/2021
• PIP number:
  EMEA-002877-PIP01-20
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of acute pain
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Aptys Pharmaceuticals

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/01/2021

Decision

P/0055/2021 : EMA decision of 27 January 2021 on the granting of a product specific waiver for nefopam (hydrochloride) / paracetamol (EMEA-002877- PIP01-20)

AdoptedReference Number: EMA/18941/2021