PRODUCT DETAIL

HyQvia 100 mg/ml infúzny roztok na subkutánne použitie

Code

5730A

MA number

EU/1/13/840/001

Product Form:

sol inf 1x25 ml (10 % IG)+1x1,25 ml (rHuPH20) (liek.inj.skl.)

MA Status:

E - Valid centralised marketing authorisation

Type of procedure:

MAH, country:

Baxalta Innovations GmbH, Austria

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 - new active substance
MA issued:	16.05.2013
SmPC + PL:	European Medicines Agency's database
Dokument:	Hyqvia_Denník pacienta.pdf
Dokument:	HyQvia_Sprievodca krok za krokom pre pacientov_Podanie infúznou pumpou.pdf
Dokument:	Hyqvia_Sprievodca krok za krokom pre pacientov_Podanie peristaltickou infúznou pumpou.pdf
Dokument:	Hyqvia_Sprievodca krok za krokom pre zdravotníckych pracovníkov_Podanie infúznou pumpou.pdf
Dokument:	Hyqvia_Sprievodca krok za krokom pre zdravotníckych pracovníkov_Podanie peristaltickou infúznou pumpou.pdf
Safety feature	Yes
Data update:	14.02.2022