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) |
|
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 |
Mylan IRE Healthcare Limited
E-mail: info.uk@viatris.com |
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
|