Binocrit

Medicinal product

(Invented) name

Binocrit

Active substance (s)

Epoetinas alfa

Strength

30000 TV/0,75 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	0.75 ml
Epoetinas alfa	30000 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
37683	51324	1051324	užpildytas švirkštas	N1		Receptinis	EU/1/07/410/023	Netiekiama	-	-	No	-	-
37684	51325	1051325	užpildytas švirkštas	N6		Receptinis	EU/1/07/410/024	Netiekiama	-	-	No	-	-
46064	59870	1059870	užpildytas švirkštas	N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/049	Netiekiama	-	-	No	-	-
46065	59871	1059871	užpildytas švirkštas	N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/050	Netiekiama	-	-	No	-	-
60538	74817	1074817	užpildytas švirkštas	N4 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/054	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas