Epoetin alfa Hexal

Medicinal product

(Invented) name

Epoetin alfa Hexal

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

Hexal AG, Vokietija

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
37691	51332	1051332	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/07/411/025	Netiekiama	-	-	No	-	-
37692	51333	1051333	užpildytas švirkštas	1 ml N6		Receptinis	EU/1/07/411/026	Netiekiama	-	-	No	-	-
46025	59831	1059831	užpildytas švirkštas	1 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/051	Netiekiama	-	-	No	-	-
46026	59832	1059832	užpildytas švirkštas	1 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/052	Netiekiama	-	-	No	-	-
59183	73406	1073406	užpildytas švirkštas	1 ml N4 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/055	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas