PRODUCT DETAIL

Immunate 500 IU FVIII/375 IU VWF

Code

89028

MA number

16/0141/06-S

Product Form:

plv iol 1x500 IU+1x5 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
B02BD06	Von Willebrand factor and coagulation factor VIII in combination

Shelf life:

Container:

glass vial

Route of admin.:

Intravenous use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 8(3) application - known active substance
MA issued:	27.03.2006
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric warnings:	Yes
SPC:	SPC_Immunate 500 IU FVIII_375 IU VWF_12.2021.pdf
PIL:	PIL_Immunate 500 IU FVIII_375 IU VWF_02.2022.pdf
Safety feature	Yes
Data update:	05.06.2018