EMEA-002352-PIP01-18 - paediatric investigation plan

irbesartan

amlodipine

Key facts

• Active Substance:
  • irbesartan
  • amlodipine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0245/2018
• PIP number:
  EMEA-002352-PIP01-18
• 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:
  15/08/2018

Decision

P/0245/2018: EMA decision of 15 August 2018 on the granting of a product specific waiver for irbesartan / amlodipine (EMEA-002352-PIP01-18)

Reference Number: EMA/469735/2018