EMEA-001391-PIP01-12
Key facts
| Active substance |
glucarpidase
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0176/2013
|
| PIP number |
EMEA-001391-PIP01-12
|
| Pharmaceutical form(s) |
Powder for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of methotrexate toxicity
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
BTG International Ltd
|
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
| Compliance procedure number |
EMEA-C-001391-PIP01-12
|
| Compliance opinion date |
24/07/2020
|
| Compliance outcome |
positive
|