HyQvia

Medicinal product

(Invented) name

HyQvia

Active substance (s)

Žmogaus normalusis imunoglobulinas (poodinis)

Strength

100 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BA01, Immunoglobulins, normal human, for extravascular adm.

Marketing authorisation holder

Baxalta Innovations GmbH, Austrija

Date of authorisation

2013-05-16

Date of renewal

Documents

HyQvia mokomoji medziaga sveikatos prieziuros specialistams.pdf

HyQvia infuziju zurnalas.pdf

HyQvia mokomoji medziaga pacientams.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for infusion	1 ml
Žmogaus normalusis imunoglobulinas (poodinis)	100 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
56261	70357	1070357	flakonas	N1 (25 ml) + N1 (1,25 ml)		Receptinis	EU/1/13/840/001	Netiekiama	-	-	No	-	-
56262	70358	1070358	flakonas	N1 (50 ml) + N1 (2.5 ml)		Receptinis	EU/1/13/840/002	Tiekiama	2025-02-03	-	No	-	-
56263	70359	1070359	flakonas	N1 (100 ml) + N1 (5 ml)		Receptinis	EU/1/13/840/003	Tiekiama	-	-	No	-	-
56264	70360	1070360	flakonas	N1 (200 ml) + N1 (10 ml)		Receptinis	EU/1/13/840/004	Tiekiama	-	-	No	-	-
56265	70361	1070361	flakonas	N1 (300 ml) + N1 (15 ml)		Receptinis	EU/1/13/840/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-05-16	Registruotas