EMEA-002248-PIP01-17 - paediatric investigation plan

Candesartan cilexetil

amlodipine besilate

Key facts

• Active substance:
  • Candesartan cilexetil
  • amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0093/2018
• PIP number:
  EMEA-002248-PIP01-17
• 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:
  16/03/2018
• Compliance check done:
  No

Decision

P/0093/2018: EMA decision of 16 March 2018 on the granting of a product specific waiver for candesartan (cilexetil) / amlodipine (besylate) (EMEA-002248-PIP01-17)

Adopted Reference Number: EMA/100992/2018