|
Code
|
75634
|
|
MA number
|
16/0392/14-S
|
|
Product Form:
|
plv iol 1x600 IU+1x20 ml solv. (liek.inj.skl.+liek.inj.skl.)
|
|
MA Status:
|
D - Marketing Authorisation valid for an unlimited period
|
|
Type of procedure:
|
Mutual recognition procedure
|
|
Therapeutic Class:
|
16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
|
|
ATC:
|
| B |
BLOOD AND BLOOD FORMING ORGANS |
| B02 |
ANTIHEMORRHAGICS |
| B02B |
LOCAL HEMOSTATICS, COMBINATIONS |
| B02BD |
Blood coagulation factors |
| B02BD01 |
Coagulation factor IX, II, VII and X in combinatio |
|
|
Shelf life:
|
36 |
|
Container:
|
glass vial (type II), with chlorobutyl rubber stopper, sealed with an aluminium flip-off cap)
|
|
Route of admin.:
|
Intravenous use
|
SPC_PROTHROMPLEX NF 600 IU_02.2022.pdf
