EMEA-000035-PIP01-07-M05
Key facts
| Invented name |
Spiriva Respimat and associated names
|
| Active substance |
Tiotropium bromide (monohydrate)
|
| Therapeutic area |
Pneumology-allergology
|
| Decision number |
P/0105/2012
|
| PIP number |
EMEA-000035-PIP01-07-M05
|
| Pharmaceutical form(s) |
Solution for inhalation via the Respimat inhaler
|
| Condition(s) / indication(s) |
Treatment of cystic fibrosis
|
| Route(s) of administration |
Inhalation use
|
| Contact for public enquiries |
Boehringer Ingelheim International GmbH
Tel. +49 6132 778271 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
|
| Compliance opinion date |
21/08/2012
|
| Compliance outcome |
positive
|