EMEA-000887-PIP01-10 - paediatric investigation plan

amlodipine

ramipril

Key facts

• Active substance:
  • amlodipine
  • ramipril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/136/2010
• PIP number:
  EMEA-000887-PIP01-10
• 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:
  28/07/2010
• Compliance check done:
  No

Decision

P/136/2010: European Medicines Agency decision of 28 July 2010 on the granting of a product specific waiver for amlodipine/ramipril (EMEA-000887-PIP01-10) in accordance with Regulation (EC) No 1901/2006 of the European ...

Adopted Reference Number: EMA/464681/2010