Cladribine - paediatric investigation plan

cladribine

Key facts

• Active substance:
  cladribine
• Therapeutic area:
  Neurology
• Decision number:
  P/101/2009
• PIP number:
  Cladribine
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Multiple Sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/05/2009
• Compliance check done:
  No

Decision

P/101/2009: European Medicines Agency decision of 19 May 2009 on the granting of a product specific waiver for cladribine (EMEA-000383-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliament ...

Adopted Reference Number: EMEA/290924/2009