EMEA-000377-PIP01-08 - paediatric investigation plan

Telmisartan

Amlodipine besilate

Key facts

• Active Substance:
  • Telmisartan
  • Amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/13/2009
• PIP number:
  EMEA-000377-PIP01-08
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Arterial hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Boehringer Ingelheim International GmbH

  Tel. [phone]; Email: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/01/2009

Decision

P/13/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product specific waiver for telmisartan and amlodipine besylate (EMEA-000377-PIP01-08) in accordance with Regulation (EC) No 1901/2006...

AdoptedReference Number: EMEA/26624/2009