EMEA-001607-PIP01-13 - paediatric investigation plan

Amlodipine besilate

Ramipril

Key facts

• Active Substance:
  • Amlodipine besilate
  • Ramipril
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0154/2014
• PIP number:
  EMEA-001607-PIP01-13
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pharmaceutical Works Polpharma SA

  Poland; E-mail: [e-mail]; Tel. [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/06/2014

Decision

P/0154/2014: EMA decision of 13 June 2014 on the granting of a product specific waiver for amlodipine besilate / ramipril (EMEA-001607-PIP01-13)

AdoptedReference Number: EMA/268742/2014