Silapo

Medicinal product

(Invented) name

Silapo

Active substance (s)

Epoetinas zeta

Strength

10000 TV/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	1 ml
Epoetinas zeta	10000 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
28244	30774	1030774	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/07/432/015	Netiekiama	-	-	No	-	-
28245	30775	1030775	užpildytas švirkštas	1 ml N6		Receptinis	EU/1/07/432/016	Netiekiama	-	-	No	-	-
103444	89546	1089546	užpildytas švirkštas	1 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/432/037	Netiekiama	-	-	No	-	-
103445	89547	1089547	užpildytas švirkštas	1 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/432/038	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas