Silapo

Medicinal product

(Invented) name

Silapo

Active substance (s)

Epoetinas zeta

Strength

3000 TV/0,9 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 syringe	0.9 ml
Epoetinas zeta	3000 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
28212	30744	1030744	užpildytas švirkštas	0,9 ml N1		Receptinis	EU/1/07/432/005	Netiekiama	-	-	No	-	-
28213	30745	1030745	užpildytas švirkštas	0,9 ml N6		Receptinis	EU/1/07/432/006	Netiekiama	-	-	No	-	-
103433	89535	1089535	užpildytas švirkštas	0,9 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/432/027	Netiekiama	-	-	No	-	-
103434	89536	1089536	užpildytas švirkštas	0,9 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/432/028	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas