EMEA-000176-PIP01-07-M05 - paediatric investigation plan

Colistimethate sodium
PIP Human

Key facts

Invented name
  • Colobreathe
  • Colobreathe
Active substance
Colistimethate sodium
Therapeutic area
Infectious diseases
Decision number
P/0173/2017
PIP number
EMEA-000176-PIP01-07-M05
Pharmaceutical form(s)
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

TEVA B.V.

United Kingdom
Tel. +44 2075407058
E-mail: rina.joshi@tevaeu.com
 

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance check done
No

Decision

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