Binocrit

Medicinal product

(Invented) name

Binocrit

Active substance (s)

Epoetinas alfa

Strength

5000 TV/0,5 ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B03XA01, Erythropoietin

Marketing authorisation holder

Sandoz GmbH, Austrija

Date of authorisation

2007-08-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in a pre-filled syringe	0.5 ml
Epoetinas alfa	5000 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
25133	27755	1027755	užpildytas švirkštas	N1		Receptinis	EU/1/07/410/009	Netiekiama	-	-	No	-	-
25134	5335	1005335	užpildytas švirkštas	N6		Receptinis	EU/1/07/410/010	Tiekiama	-	-	No	-	-
46050	59856	1059856	užpildytas švirkštas	N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/035	Netiekiama	-	-	No	-	-
46051	59857	1059857	užpildytas švirkštas	N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/036	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas