EMEA-000548-PIP01-09-M08

Adopted

First published: 28/11/2018
EMA/324470/2018

Invented name	Foster and associated names Kantos and associated names Kantos Master and associated names Inuvair and associated names
Active substance	Beclometasone dipropionate formoterol fumarate dihydrate
Therapeutic area	Pneumology-allergology
Decision number	P/0159/2018
PIP number	EMEA-000548-PIP01-09-M08
Pharmaceutical form(s)	Inhalation powder Pressurised inhalation, solution
Condition(s) / indication(s)	Treatment of asthma
Route(s) of administration	Inhalation use
Contact for public enquiries	Chiesi Farmaceutici S.p.A. Tel. +39 0521 2791 E-mail: info@chiesi.com
Decision type	PM: decision on the application for modification of an agreed PIP
Compliance procedure number	EMEA-C-000548-PIP01-09-M08
Compliance opinion date	26/04/2019
Compliance outcome	positive