Epoetin alfa Hexal

Medicinal product

(Invented) name

Epoetin alfa Hexal

Active substance (s)

Epoetinas alfa

Strength

10000 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	10000 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
25434	28042	1028042	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/07/411/015	Netiekiama	-	-	No	-	-
25435	28043	1028043	užpildytas švirkštas	1 ml N6		Receptinis	EU/1/07/411/016	Netiekiama	-	-	No	-	-
46019	59825	1059825	užpildytas švirkštas	1 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/045	Netiekiama	-	-	No	-	-
46020	59826	1059826	užpildytas švirkštas	1 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/046	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas