EMEA-002192-PIP02-17 - paediatric investigation plan

amlodipine

irbesartan

Key facts

• Active substance:
  • amlodipine
  • irbesartan
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0145/2018
• PIP number:
  EMEA-002192-PIP02-17
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/05/2018
• Compliance check done:
  No

Decision

P/0145/2018: EMA decision of 7 May 2018 on the granting of a product specific waiver for amlodipine / irbesartan (EMEA-002192-PIP02-17)

Adopted Reference Number: EMA/258460/2018