EMEA-002825-PIP01-20 - paediatric investigation plan

Cluster of differentiation 40 (CD40) ligand antagonist comprising two identical Tn3 modules fused to human serum albumin, with each Tn3 module being an engineered form of the third fibronectin type III protein domain of human Tenascin C (VIB4920)

Key facts

• Active substance:
  Cluster of differentiation 40 (CD40) ligand antagonist comprising two identical Tn3 modules fused to human serum albumin, with each Tn3 module being an engineered form of the third fibronectin type III protein domain of human Tenascin C (VIB4920)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0352/2020
• PIP number:
  EMEA-002825-PIP01-20
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Sjögren's 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:
  09/09/2020
• Compliance check done:
  No

Decision

P/0352/2020 : EMA decision of 9 September 2020 on the granting of a product specific waiver for cluster of differentiation 40 (CD40) ligand antagonist comprising two identical Tn3 modules fused to human serum albumin....(EMEA-002825-PIP01-20)

Adopted Reference Number: EMA/419207/2020