EMEA-001962-PIP01-16 - paediatric investigation plan

Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody

Key facts

• Active Substance:
  Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0244/2016
• PIP number:
  EMEA-001962-PIP01-16
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of systemic light chain amyloidosis
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Prothena Therapeutics Limited

  Ireland; Tel. [phone]; Fax [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  09/09/2016

Decision

P/0244/2016: EMA decision of 9 September 2016 on the granting of a product specific waiver for humanized IgG1, kappa anti-serum amyloid A and anti- AL amyloid antibody (EMEA-001962-PIP01-16)

AdoptedReference Number: EMA/513695/2016