Binocrit

Medicinal product

(Invented) name

Binocrit

Active substance (s)

Epoetinas alfa

Strength

9000 TV/0,9 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	0.9 ml
Epoetinas alfa	9000 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
30990	33440	1033440	užpildytas švirkštas	N1		Receptinis	EU/1/07/410/019	Netiekiama	-	-	No	-	-
30991	33441	1033441	užpildytas švirkštas	N6		Receptinis	EU/1/07/410/020	Netiekiama	-	-	No	-	-
46058	59864	1059864	užpildytas švirkštas	N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/043	Netiekiama	-	-	No	-	-
46059	59865	1059865	užpildytas švirkštas	N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/044	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas