EMEA-001435-PIP02-16-M02 - paediatric investigation plan

anifrolumab
PIPHuman

Key facts

Invented name
Saphnelo
Active Substance
anifrolumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0149/2023
PIP number
EMEA-001435-PIP02-16-M02
Pharmaceutical form(s)
  • Solution for injection
  • Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of Systemic Lupus Erythematosus (SLE)
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries

AstraZeneca AB

Email: paediatrics@astrazeneca.com 
Tel. +46 855324400 
 

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

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