Epoetin alfa Hexal

Medicinal product

(Invented) name

Epoetin alfa Hexal

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

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	0.8 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
25432	28040	1028040	užpildytas švirkštas	0,8 ml N1		Receptinis	EU/1/07/411/013	Netiekiama	-	-	No	-	-
25433	28041	1028041	užpildytas švirkštas	0,8 ml N6		Receptinis	EU/1/07/411/014	Netiekiama	-	-	No	-	-
46015	59821	1059821	užpildytas švirkštas	0,8 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/041	Netiekiama	-	-	No	-	-
46016	59822	1059822	užpildytas švirkštas	0,8 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/042	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas