EMEA-002462-PIP01-18 - paediatric investigation plan

telmisartan

Indapamide

Key facts

• Active substance:
  • telmisartan
  • Indapamide
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0024/2019
• PIP number:
  EMEA-002462-PIP01-18
• 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:
  11/01/2019
• Compliance check done:
  No

Decision

P/0024/2019: EMA decision of 11 January 2019 on the granting of a product specific waiver for telmisartan / indapamide (EMEA-002462-PIP01-18)

Reference Number: EMA/895013/2018