Abseamed

Medicinal product

(Invented) name

Abseamed

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

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	0.8 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
23885	26566	1026566	užpildytas švirkštas	0,8 ml, N1		Receptinis	EU/1/07/412/013	Netiekiama	-	-	No	-	-
23886	26567	1026567	užpildytas švirkštas	0,8 ml, N6		Receptinis	EU/1/07/412/014	Netiekiama	-	-	No	-	-
45793	59595	1059595	užpildytas švirkštas	0,8 ml N1 (su apsaugine adatos priemone)		Receptinis	EU/1/07/412/041	Netiekiama	-	-	No	-	-
45794	59596	1059596	užpildytas švirkštas	0,8 ml N6 (su apsaugine adatos priemone)		Receptinis	EU/1/07/412/042	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-28	Registruotas