Silapo

Medicinal product

(Invented) name

Silapo

Active substance (s)

Epoetinas zeta

Strength

4000 TV/0,4 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	0.4 ml
Epoetinas zeta	4000 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
28238	30768	1030768	užpildytas švirkštas	0.4 ml N1		Receptinis	EU/1/07/432/007	Netiekiama	-	-	No	-	-
28239	30769	1030769	užpildytas švirkštas	0.4 ml N6		Receptinis	EU/1/07/432/008	Netiekiama	-	-	No	-	-
103436	89538	1089538	užpildytas švirkštas	0,4 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/432/029	Netiekiama	-	-	No	-	-
103437	89539	1089539	užpildytas švirkštas	0,4 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/432/030	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas