Epoetin alfa Hexal

Medicinal product

(Invented) name

Epoetin alfa Hexal

Active substance (s)

Epoetinas alfa

Strength

20000 TV/0,5 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	0.5 ml
Epoetinas alfa	20000 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
37687	51328	1051328	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/07/411/021	Netiekiama	-	-	No	-	-
37688	51329	1051329	užpildytas švirkštas	0,5 ml N6		Receptinis	EU/1/07/411/022	Netiekiama	-	-	No	-	-
46021	59827	1059827	užpildytas švirkštas	0,5 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/047	Netiekiama	-	-	No	-	-
46022	59828	1059828	užpildytas švirkštas	0,5 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/048	Netiekiama	-	-	No	-	-
59181	73404	1073404	užpildytas švirkštas	0,5 ml N4 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/053	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas