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