Jivi

Medicinal product

(Invented) name

Jivi

Active substance (s)

Žmogaus VIII (rDNR) koaguliacijos faktorius

Strength

500 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BD02, Coagulation factor VIII

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2018-11-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	2.5 ml
Žmogaus VIII (rDNR) koaguliacijos faktorius	500 TV

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
100632	86742	1086742	flakonas	milteliai, injekcinio vandens užpildytas švirkštas (2,5 ml), flakono adapteris ir venepunkcijos rinkinys N1		Receptinis	EU/1/18/1324/002	Netiekiama	-	-	No	-	-
103306	89408	1089408	flakonas	milteliai, injekcinio vandens užpildytas švirkštas (2,5 ml), flakono adapteris ir venepunkcijos rinkinys N30		Receptinis	EU/1/18/1324/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-22	Registruotas