EMEA-000872-PIP01-10-M03 - paediatric investigation plan

Human normal immunoglobulin

Key facts

• Invented name:
  • HyQvia
  • HyQvia
• Active Substance:
  Human normal immunoglobulin
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0186/2015
• PIP number:
  EMEA-000872-PIP01-10-M03
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of primary immunodeficiency (PID) as model for replacement therapy
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Baxalta Innovations GmbH

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/08/2015
• Compliance procedure number:
  EMEA-C-000872-PIP01-10-M03
• Compliance opinion date:
  30/10/2015
• Compliance outcome:
  Positive

Decision

P/0186/2015: EMA decision of 27 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (HyQvia) (EMEA-000872-PIP01-10-M03)

AdoptedReference Number: EMA/556402/2015