Binocrit

Medicinal product

(Invented) name

Binocrit

Active substance (s)

Epoetinas alfa

Strength

20000 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	20000 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
37681	51322	1051322	užpildytas švirkštas	N1		Receptinis	EU/1/07/410/021	Netiekiama	-	-	No	-	-
37682	51323	1051323	užpildytas švirkštas	N6		Receptinis	EU/1/07/410/022	Netiekiama	-	-	No	-	-
46062	59868	1059868	užpildytas švirkštas	N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/047	Netiekiama	-	-	No	-	-
46063	59869	1059869	užpildytas švirkštas	N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/048	Netiekiama	-	-	No	-	-
60537	74816	1074816	užpildytas švirkštas	N4 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/053	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas