Binocrit

Medicinal product

(Invented) name

Binocrit

Active substance (s)

Epoetinas alfa

Strength

40000 TV/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	1 ml
Epoetinas alfa	40000 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
37685	51326	1051326	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/07/410/025	Netiekiama	-	-	No	-	-
37686	51327	1051327	užpildytas švirkštas	1 ml N6		Receptinis	EU/1/07/410/026	Netiekiama	-	-	No	-	-
46066	59872	1059872	užpildytas švirkštas	1 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/051	Netiekiama	-	-	No	-	-
46067	59873	1059873	užpildytas švirkštas	1 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/052	Netiekiama	-	-	No	-	-
60539	74818	1074818	užpildytas švirkštas	1 ml N4 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/055	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas