Epoetin alfa Hexal

Medicinal product

(Invented) name

Epoetin alfa Hexal

Active substance (s)

Epoetinas alfa

Strength

30000 TV/0,75 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	0.75 ml
Epoetinas alfa	30000 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
37689	51330	1051330	užpildytas švirkštas	0,75 ml N1		Receptinis	EU/1/07/411/023	Netiekiama	-	-	No	-	-
37690	51331	1051331	užpildytas švirkštas	0,75 ml N6		Receptinis	EU/1/07/411/024	Netiekiama	-	-	No	-	-
46023	59829	1059829	užpildytas švirkštas	0,75 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/049	Netiekiama	-	-	No	-	-
46024	59830	1059830	užpildytas švirkštas	0,75 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/050	Netiekiama	-	-	No	-	-
59182	73405	1073405	užpildytas švirkštas	0,75 ml N4 (su apsaugine adatos priemone)		Receptinis	EU/1/07/411/054	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas