EMEA-001231-PIP02-13-M08
Key facts
| Invented name |
Samsca and associated names
|
| Active substance |
Tolvaptan
|
| Therapeutic area |
Endocrinology, -gynacology-fertility-metabolism
|
| Decision number |
P/0383/2021
|
| PIP number |
EMEA-001231-PIP02-13-M08
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Otsuka Pharmaceutical Netherlands B.V.
E-mail: paediatric-info@otsuka-europe.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|