EMEA-001852-PIP01-15 - paediatric investigation plan

olmesartan medoxomil

amlodipine besilate

Key facts

• Active substance:
  • olmesartan medoxomil
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0293/2015
• PIP number:
  EMEA-001852-PIP01-15
• Pharmaceutical form(s):
  Film-coated 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:
  27/11/2015
• Compliance check done:
  Nej

Decision

P/0293/2015: EMA decision of 27 November 2015 on the granting of a product specific waiver for olmesartan medoxomil / amlodipine (besilate) (EMEA-001852-PIP01-15)

Adopted Reference Number: EMA/689489/2015