EMEA-000045-PIP01-07 - paediatric investigation plan

telmisartan

ramipril

Key facts

• Active substance:
  • telmisartan
  • ramipril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/3/2008
• PIP number:
  EMEA-000045-PIP01-07
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Risk of myocardial infarction, stroke, death from cardiovascular causes, or hospitalization forcongestive heart failure in patients at high risk of developing major cardiovascular events
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/02/2008
• Compliance check done:
  No

Decision

P/3/2008: European medicines agency decision of 1 February 2008 on the application for product specific waiver for Telmisartan/ramipril (fixed combination) EMEA-000045-PIP01-07 in accordance with Regulation (EC) No 1901/...

Adopted Reference Number: EMEA/43360/2008