EMEA-000719-PIP02-10 - paediatric investigation plan

atorvastatin (L-lysine salt)

Amlodipine besilate

Key facts

• Active Substance:
  • atorvastatin (L-lysine salt)
  • Amlodipine besilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/45/2011
• PIP number:
  EMEA-000719-PIP02-10
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of atherosclerotic heart disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gedeon Richter Plc.

  [e-mail]; Hungary; [phone]; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/03/2011

Decision

P/45/2011: EMA decision of the 3 March 2011 on the granting of a product specific waiver for atorvastatin (L-lysine salt) / amlodipine (besilate) (EMEA-000719-PIP02-10) in accordance with Regulation (EC) No 1901/2006 of ...

AdoptedReference Number: EMA/115356/201