EMEA-000300-PIP01-08-M04
Key facts
| Invented name |
Alipza and associated names
|
| Active substance |
Pitavastatin (calcium)
|
| Therapeutic area |
Endocrinology-Gynaecology-Fertility-Metabolism
|
| Decision number |
P/0096/2016
|
| PIP number |
EMEA-000300-PIP01-08-M04
|
| Pharmaceutical form(s) |
Film-coated tablet
|
| Condition(s) / indication(s) |
Treatment of disorders of lipoprotein metabolism and other lipidaemias
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Kowa Pharmaceutical Europe Company Ltd
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000300-PIP01-08-M04
|
| Compliance opinion date |
19/08/2016
|
| Compliance outcome |
positive
|