EMEA-001435-PIP02-16

Key facts

Invented name
Vandaag
Active substance
Anifrolumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0075/2018
PIP number
EMEA-001435-PIP02-16
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of Systemic Lupus Erythematosus (SLE)
Route(s) of administration
  • Intravenous use
  • Subcutaneous use
Contact for public enquiries
AstraZeneca AB (Sweden)

Tel. +46 8 55327591
E-mail: paediatrics@astrazeneca.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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