EMEA-002672-PIP01-19 - paediatric investigation plan

Ethanol

Key facts

• Active substance:
  Ethanol
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0016/2020
• PIP number:
  EMEA-002672-PIP01-19
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of uncontrolled primary hypertension
• Route(s) of administration:
  Intraarterial use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  06/01/2020
• Compliance check done:
  No

Decision

P/0016/2020: EMA decision of 6 January 2020 on the granting of a product specific waiver for ethanol (EMEA-002672-PIP01-19)

Adopted Reference Number: EMA/659448/2019