EMEA-000184-PIP01-08-M02

Key facts

Invented name
Tobi Podhaler
Active substance
Tobramycin
Therapeutic area
Infectious diseases
Decision number
P/0177/2014
PIP number
EMEA-000184-PIP01-08-M02
Pharmaceutical form(s)
  • Inhalation powder
  • Capsule, hard
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 61 324 1111
Fax +41 61 8001
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000184-PIP01-08-M02
Compliance opinion date
12/09/2014
Compliance outcome
positive

Decision

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