EMEA-003479-PIP01-23 - paediatric investigation plan

glyceryl trinitrate

Key facts

• Active substance:
  glyceryl trinitrate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0486/2023
• PIP number:
  EMEA-003479-PIP01-23
• Pharmaceutical form(s):
  Sublingual spray
• Condition(s) / indication(s):
  • Prevention of cardiac and vascular procedural complications
  • Treatment of heart failure
  • Treatment of ischaemic coronary artery disorders
• Route(s) of administration:
  Sublingual use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/11/2023
• Compliance check done:
  No

Decision

P/0486/2023: EMA decision of 30 November 2023 on the granting of a product specific waiver for glyceryl trinitrate (Nitromint), (EMEA-003479-PIP01- 23)

Adopted Reference Number: EMA/494466/2023