EMEA-002147-PIP02-17-M01
Key facts
| Active substance |
Sodium thiosulfate
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0368/2019
|
| PIP number |
EMEA-002147-PIP02-17-M01
|
| Pharmaceutical form(s) |
Solution for infusion
|
| Condition(s) / indication(s) |
Prevention of platinum-induced ototoxic hearing loss
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Fennec Pharmaceuticals, Inc.
E-mail: info@s-cubed.co.uk |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-002147-PIP02-17-M01
|
| Compliance opinion date |
11/12/2019
|
| Compliance outcome |
positive
|