EMEA-002212-PIP01-17 - paediatric investigation plan

Meldonium dihydrate

Key facts

• Active substance:
  Meldonium dihydrate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0304/2017
• PIP number:
  EMEA-002212-PIP01-17
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of angina pectoris
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/10/2017
• Compliance check done:
  No

Decision

P/0304/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for meldonium (dihydrate) (EMEA-002212-PIP01-17)

Adopted Reference Number: EMA/666635/2017