EMEA-001084-PIP02-11 - paediatric investigation plan

rivastigmine

Key facts

• Invented name:
  • Exelon
  • • Exelon
    • Prometax
• Active Substance:
  rivastigmine
• Therapeutic area:
  Neurology
• Decision number:
  P/113/2011
• PIP number:
  EMEA-001084-PIP02-11
• Pharmaceutical form(s):
  • Capsule, hard
  • Oral solution
  • Transdermal patch
• Condition(s) / indication(s):
  Treatment of dementia
• Route(s) of administration:
  • Oral use
  • Transdermal use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/04/2011

Decision

P/113/2011: EMA decision of 27 April 2011 on the granting of a product specific waiver for rivastigmine (Exelon and Prometax) (EMEA-001084- PIP02-11)

AdoptedReference Number: EMA/320397/2011