Epoetin alfa Hexal

Medicinal product

(Invented) name

Epoetin alfa Hexal

Active substance (s)

Epoetinas alfa

Strength

1000 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	1000 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
25420	28028	1028028	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/07/411/001	Netiekiama	-	-	No	-	-
25421	28029	1028029	užpildytas švirkštas	0,5 ml N6		Receptinis	EU/1/07/411/002	Netiekiama	-	-	No	-	-
45967	59771	1059771	užpildytas švirkštas	0,5 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/027	Netiekiama	-	-	No	-	-
45968	59772	1059772	užpildytas švirkštas	0,5 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/027	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas