EMEA-000884-PIP01-10 - paediatric investigation plan

Tafamidis meglumine

Key facts

• Active Substance:
  Tafamidis meglumine
• Therapeutic area:
  Neurology
• Decision number:
  P/147/2010
• PIP number:
  EMEA-000884-PIP01-10
• Pharmaceutical form(s):
  Capsule (soft)
• Condition(s) / indication(s):
  Neuropathic heredofamilial amyloidosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  FoldRx Pharmaceuticals

  E-mail: [e-mail]; United States; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/07/2010

Decision

P/147/2010: European Medicines Agency decision of 30 July 2010 on the granting of a product specific waiver for tafamidis meglumine (EMEA-000884-PIP01-10) in accordance with Regulation (EC) No 1901/2006 of the European ...

AdoptedReference Number: EMA/425477/2010