Biphozyl

Medicinal product

(Invented) name

Biphozyl

Active substance (s)

Magnio chloridas heksahidratas+Natrio chloridas/Natrio-vandenilio karbonatas/Kalio chloridas/Dinatrio fosfatas dihidratas

Strength

3,05 g/l + 7,01 g/2,12 g/0,314 g/0,187 g/l

Pharmaceutical form

hemodializės ar hemofiltracijos tirpalas

Route (s) of administration

leisti į veną, hemodializei

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B05ZB, Hemofiltrates

Marketing authorisation holder

Vantive Belgium SRL, Belgija

Date of authorisation

2015-04-22

Date of renewal

2019-07-02

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

NL/H/3002/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Mažojo skyriaus A (250 ml) 1 l tirpalo yra	250 ml
Magnio chloridas heksahidratas	3,05 g
Didžiojo skyriaus B (4750 ml) 1 l tirpalo yra	4750 ml
Natrio chloridas	7,01 g
Natrio-vandenilio karbonatas	2,12 g
Kalio chloridas	0,314 g
Dinatrio fosfatas dihidratas	0,187 g

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
57083	71196	1071196	maišelis	5000 ml (250 ml + 4750 ml) N2		Receptinis	LT/1/15/3706/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-07-02	Perregistruotas
2015-04-22	Registruotas