EMEA-000184-PIP02-14

Key facts

Invented name
Tobi
Active substance
Tobramycin
Therapeutic area
Pneumology-allergology
Decision number
P/0184/2014
PIP number
EMEA-000184-PIP02-14
Pharmaceutical form(s)
Nebuliser solution
Condition(s) / indication(s)
Treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
Route(s) of administration
Inhalation use
Contact for public enquiries
Novartis Europharm Ltd
United Kingdom 
E-mail: clinicaltrial.enquiries@novartis.com 
Tel. +41 613241111
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-000184-PIP02-14
Compliance opinion date
29/04/2016
Compliance outcome
positive

Decision

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