Silapo

Medicinal product

(Invented) name

Silapo

Active substance (s)

Epoetinas zeta

Strength

20000 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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2007-12-18

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 pre-filled pen	0.5 ml
Epoetinas zeta	20000 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
28246	30776	1030776	užpildytas švirkštas	0.5 ml N1		Receptinis	EU/1/07/432/017	Netiekiama	-	-	No	-	-
42340	56107	1056107	užpildytas švirkštas	0.5 ml N4		Receptinis	EU/1/07/432/020	Netiekiama	-	-	No	-	-
103446	89548	1089548	užpildytas švirkštas	0,5 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/432/039	Netiekiama	-	-	No	-	-
103447	89549	1089549	užpildytas švirkštas	0,5 ml N4 (su adatos apsauga)		Receptinis	EU/1/07/432/040	Netiekiama	-	-	No	-	-
105392	91492	1091492	užpildytas švirkštas	0,5 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/432/045	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas