EMEA-002766-PIP01-20
Key facts
| Active substance |
Recombinant human IgGlA monoclonal Fab antibody
|
| Therapeutic area |
Cardiovascular diseases
|
| Decision number |
P/0262/2020
|
| PIP number |
EMEA-002766-PIP01-20
|
| Pharmaceutical form(s) |
Solution for infusion
|
| Condition(s) / indication(s) |
Reversal of antiplatelet effects of ticagrelor in patients with uncontrolled major or life-threatening bleeding or requiring urgent surgery or invasive procedure
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
PhaseBio Pharmaceuticals Inc.
E-mail: lauren.richardson@phasebio.com |
| Decision type |
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
|