EMEA-000885-PIP01-10 - paediatric investigation plan

telmisartan

hydrochlorothiazide

Key facts

• Invented name:
  • MicardisPlus
  • MicardisPlus
• Active substance:
  • telmisartan
  • hydrochlorothiazide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/159/2010
• PIP number:
  EMEA-000885-PIP01-10
• Pharmaceutical form(s):
  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:
  27/08/2010
• Compliance check done:
  Ne

Decision

P/159/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a product specific waiver for telmisartan / hydrochlorothiazide (MicardisPlus) (EMEA-000885-PIP01-10)

Adopted Reference Number: EMA/477373/2010