EMEA-001812-PIP01-15-M02 - paediatric investigation plan

Indacaterol (acetate)
Mometasone (furoate)
Glycopyrronium bromide
PIPHuman

Key facts

Invented name
  • Enerzair Breezhaler
  • Zimbus Breezhaler
Active Substance
  • Indacaterol (acetate)
  • Mometasone (furoate)
  • Glycopyrronium bromide
Therapeutic area
Pneumology-allergology
Decision number
P/0493/2023
PIP number
EMEA-001812-PIP01-15-M02
Pharmaceutical form(s)
  • Inhalation powder
  • Capsule, hard
Condition(s) / indication(s)
Treatment of asthma
Route(s) of administration
Inhalation use
Contact for public enquiries

Novartis Europharm Ltd.

Tel. +41 613241111
E-mail: paediatric.enquiries@novartis.com
 

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

Decision

P/0493/2023 : EMA decision of 1 Dec 2023 on the acceptance of a modification of an agreed PIP for indacaterol (acetate) / glycopyrronium (bromide) / mometasone (furoate), (Enerzair Breezhaler, Zimbus Breezhaler), (EMEA-001812-PIP01-15-M02)

Reference Number: EMA/530330/2023

English (EN) (311.77 KB - PDF)

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