EMEA-001942-PIP01-16 - paediatric investigation plan

ramipril

amlodipine

hydrochlorothiazide

Key facts

• Active substance:
  • ramipril
  • amlodipine
  • hydrochlorothiazide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0226/2016
• PIP number:
  EMEA-001942-PIP01-16
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  12/08/2016
• Compliance check done:
  No

Decision

P/0226/2016: EMA decision of 12 August 2016 on the granting of a product specific waiver for ramipril / amlodipine / hydrochlorothiazide (EMEA- 001942-PIP01-16)

Adopted Reference Number: EMA/472133/2016