EMEA-000694-PIP01-09-M08
Key facts
| Invented name |
Forxiga
|
| Active substance |
dapagliflozin
|
| Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
| Decision number |
P/0086/2020
|
| PIP number |
EMEA-000694-PIP01-09-M08
|
| Pharmaceutical form(s) |
Film-coated tablet
|
| Condition(s) / indication(s) |
Treatment of type II diabetes mellitus
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
AstraZeneca AB (Sweden)
E-mail: paediatrics@astrazeneca.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000694-PIP01-09-M08
|
| Compliance opinion date |
11/12/2020
|
| Compliance outcome |
positive
|