Key facts

Invented name
Fasenra
Active Substance
Benralizumab
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0388/2021
PIP number
EMEA-001214-PIP05-19
Pharmaceutical form(s)
  • Solution for injection
  • Solution for injection/infusion
  • Age-appropriate dosage form for parenteral use
Condition(s) / indication(s)
Treatment of eosinophilic esophagitis
Route(s) of administration
  • Subcutaneous use
  • Intravenous use
Contact for public enquiries

AstraZeneca AB

E-mail: paediatrics@astrazeneca.com
Tel.  +46 855326000
 

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

Decision

P/0388/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benralizumab (Fasenra) (EMEA-001214-PIP05-19)

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