Binocrit

Medicinal product

(Invented) name

Binocrit

Active substance (s)

Epoetinas alfa

Strength

8000 TV/0,8 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	0.8 ml
Epoetinas alfa	8000 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
25137	27759	1027759	užpildytas švirkštas	N1		Receptinis	EU/1/07/410/013	Netiekiama	-	-	No	-	-
25138	27760	1027760	užpildytas švirkštas	N6		Receptinis	EU/1/07/410/014	Netiekiama	-	-	No	-	-
46056	59862	1059862	užpildytas švirkštas	N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/041	Netiekiama	-	-	No	-	-
46057	59863	1059863	užpildytas švirkštas	N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/410/042	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas