EMEA-001948-PIP01-16 - paediatric investigation plan

Indapamide

Perindopril erbumine

Amlodipine besilate

Key facts

• Active Substance:
  • Indapamide
  • Perindopril erbumine
  • Amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0245/2016
• PIP number:
  EMEA-001948-PIP01-16
• 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:
  09/09/2016

Decision

P/0245/2016: EMA decision of 12 September 2016 on the granting of a product specific waiver for amlodipine (besylate) / perindopril (erbumine) / indapamide (EMEA-001948-PIP01-16)

AdoptedReference Number: EMA/513669/2016