Epoetin alfa Hexal

Medicinal product

(Invented) name

Epoetin alfa Hexal

Active substance (s)

Epoetinas alfa

Strength

2000 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	2000 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
25422	28030	1028030	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/07/411/003	Netiekiama	-	-	No	-	-
25423	28031	1028031	užpildytas švirkštas	1 ml N6		Receptinis	EU/1/07/411/004	Netiekiama	-	-	No	-	-
45969	59773	1059773	užpildytas švirkštas	1 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/029	Netiekiama	-	-	No	-	-
45970	59774	1059774	užpildytas švirkštas	1 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/030	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas