EMEA-003216-PIP01-22 - paediatric investigation plan

Magnesium lactate dihydrate Tramadol (hydrochloride)

Key facts

• Active substance:
  Magnesium lactate dihydrate Tramadol (hydrochloride)
• Therapeutic area:
  Other
• Decision number:
  P/0273/2022
• PIP number:
  EMEA-003216-PIP01-22
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  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:
  10/08/2022
• Compliance check done:
  No

Decision

P/0273/2022: EMA decision on the granting of a product specific waiver for tramadol (hydrochloride) / magnesium lactate dihydrate (EMEA-003216-PIP01-22)

Adopted Reference Number: EMA/659404/2022