|
Code
|
65619
|
|
MA number
|
16/0111/09-S
|
|
Product Form:
|
plv iio 1x500 IU+1x10 ml solv. (liek.inj.skl.+liek.inj.skl.)
|
|
MA Status:
|
D - Marketing Authorisation valid for an unlimited period
|
|
Type of procedure:
|
Mutual recognition procedure
|
|
MAH, country:
|
CSL Behring GmbH, Germany
|
|
Therapeutic Class:
|
16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
|
|
ATC:
|
| B |
BLOOD AND BLOOD FORMING ORGANS |
| B06 |
OTHER HEMATOLOGICAL AGENTS |
| B06A |
OTHER HEMATOLOGICAL AGENTS |
| B06AC |
Drugs used in hereditary angioedema |
| B06AC01 |
C1-inhibitor, plasma derived |
|
|
Shelf life:
|
36 |
|
Container:
|
glass vial
|
|
Route of admin.:
|
Intravenous use
|
SPC Berinert_500 IU_1500 IU_12.2021.pdf
