EMEA-000012-PIP01-07-M01
Key facts
| Invented name |
Singulair
|
| Active substance |
Montelukast sodium
|
| Therapeutic area |
Pneumology-allergology
|
| Decision number |
P/200/2009
|
| PIP number |
EMEA-000012-PIP01-07-M01
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Asthma
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Merck Sharp & Dohme Ltd.
E-mail: regaffairseurope@organon.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000012-PIP01-07-M01
|
| Compliance opinion date |
15/01/2010
|
| Compliance outcome |
positive
|