EMEA-001211-PIP01-11-M01

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Overview

Product details for
Invented name
Active substance

Levofloxacin (hemihydrate)

Decision numberP/0187/2013
PIP numberEMEA-001211-PIP01-11-M01
Pharmaceutical form(s)Nebuliser solution
Condition(s)/indication(s)

Treatment of cystic fibrosis

Route(s) of administrationInhalation use
PIP applicant

Aptalis Pharma SAS
Tel. +39 0521 2791
E-mail: s.donadoni@chiesi.com

Decision typePM: decision on the application for modification of an agreed PIP

Decision