EMEA-002063-PIP01-16

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Overview

Product details for -
Invented name-
Active substance

Budesonide

Decision numberP/0384/2017
PIP numberEMEA-002063-PIP01-16
Pharmaceutical form(s)Pressurised inhalation, suspension
Condition(s)/indication(s)

Treatment of asthma

Route(s) of administrationInhalation use
PIP applicant

Pearl Therapeutics, Inc.
Tel. +44 1625230700
E-mail: paediatrics@astrazeneca.com

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

Decision