EMEA-001207-PIP03-20 - paediatric investigation plan

Obinutuzumab

Key facts

• Invented name:
  Gazyvaro
• Active substance:
  Obinutuzumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0512/2020
• PIP number:
  EMEA-001207-PIP03-20
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of glomerulonephritis and nephrotic syndrome
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/12/2020
• Compliance check done:
  No

Decision

P/0512/2020 : EMA decision of 22 December 2020 on the refusal of a product specific waiver for obinutuzumab (Gazyvaro) (EMEA-001207-PIP03-20)

Adopted Reference Number: EMA/636283/2020