Obizur

Medicinal product

(Invented) name

Obizur

Active substance (s)

Antihemofilinis VIII faktorius (rDNR), kiaulės sekos

Strength

500 V

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)

B02BD14, Susoctocog alfa

Marketing authorisation holder

Baxalta Innovations GmbH, Austrija

Date of authorisation

2015-11-11

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	1 vnt.
Antihemofilinis VIII faktorius (rDNR), kiaulės sekos	500 V

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
64210	78670	1078670	flakonas	milteliai, užpildytas švirkštas ir flakono adapteris N1		Receptinis	EU/1/15/1035/001	Netiekiama	-	-	No	-	-
64211	78671	1078671	flakonas	milteliai, užpildytas švirkštas ir flakono adapteris N5		Receptinis	EU/1/15/1035/002	Netiekiama	-	-	No	-	-
64212	78672	1078672	flakonas	milteliai, užpildytas švirkštas ir flakono adapteris N10		Receptinis	EU/1/15/1035/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-11	Registruotas