P/5/2010 - 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/5/2010
• PIP number:
  P/5/2010
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Hypertension with dyslipidemia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gedeon Richter Plc.

  E-mail: [e-mail]; Country: Hungary; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  25/01/2010

Decision

P/5/2010: European Medicines Agency decision of 25 January 2010 on the granting of a product specific waiver for atorvastatin (L-lysine salt) / amlodipine besilate (EMEA-000719-PIP01-09) in accordance with Regulation (E...

AdoptedReference Number: EMEA/35952/2010