Abseamed

Medicinal product

(Invented) name

Abseamed

Active substance (s)

Epoetinas alfa

Strength

5000 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

Medice Arzneimittel Pütter GmbH & Co KG, 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	5000 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
23881	26562	1026562	užpildytas švirkštas	0,5ml, N1		Receptinis	EU/1/07/412/009	Netiekiama	-	-	No	-	-
23882	26563	1026563	užpildytas švirkštas	0,5 ml, N6		Receptinis	EU/1/07/412/010	Netiekiama	-	-	No	-	-
45787	59589	1059589	užpildytas švirkštas	0,5 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/412/035	Netiekiama	-	-	No	-	-
45788	59590	1059590	užpildytas švirkštas	0,5 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/412/036	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas