PRODUCT DETAIL

Prothromplex Total NF 500 IU

Code

3601E

MA number

75/0118/23-S

Product Form:

plv iol 1x500 IU+1x17 ml solv. (liek.inj.skl.+liek.inj.skl.+liek.inj. na rekonštitúciu)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Decentralised

Therapeutic Class:

75 - SUBSTITUTIO SANGUINIS (A KRVNÉ DERIVÁTY)

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:

Container:

vial

Route of admin.:

Intravenous use

Prescription Status:	Medicinal product subject to restricted medical prescription.
Legal basis:	Article 8(3) application - known active substance
MA issued:	26.05.2023
Validity:	26.05.2028
Pediatric warnings:	Yes
SPC:	SPC_Prothromplex Total NF 500 IU_05 2023.pdf
PIL:	PIL_Prothromplex Total NF 500 IU_05 2023.pdf
Safety feature	Yes
Data update:	15.06.2023