PRODUCT DETAIL

Xembify 200 mg/ml roztok na subkutánnu injekciu

Code

9511D

MA number

59/0018/22-S

Product Form:

sol icu 1x10 ml/2 g (liek.inj.skl.)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Decentralised

MAH, country:

Instituto Grifols, S.A., Spain

Therapeutic Class:

59 - IMMUNOPRAEPARATA

ATC:

J	ANTIINFECTIVES FOR SYSTEMIC USE
J06	IMMUNE SERA AND IMMUNOGLOBULINS
J06B	IMMUNOGLOBULINS
J06BA	Immunoglobulins, normal human
J06BA01	Immunoglobulins, normal human, for extravascular application

Shelf life:

Container:

glass vial

Route of admin.:

Subcutaneous use

Prescription Status:	Medicinal product subject to restricted medical prescription.
Legal basis:	Article 8(3) application - known active substance
MA issued:	27.04.2022
Validity:	27.04.2027
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric warnings:	Yes
SPC:	SPC_Xembify 200 mg_ml roztok na subkutánnu injekciu_12.2024.pdf
PIL:	PIL_Xembify 200 mg_ml roztok na subkutánnu injekciu_12. 2024.pdf
Safety feature	Yes
Data update:	28.04.2022