Silapo

Medicinal product

(Invented) name

Silapo

Active substance (s)

Epoetinas zeta

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

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	0.8 ml
Epoetinas zeta	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
28242	30772	1030772	užpildytas švirkštas	0,8 ml N1		Receptinis	EU/1/07/432/013	Netiekiama	-	-	No	-	-
28243	30773	1030773	užpildytas švirkštas	0,8 ml N6		Receptinis	EU/1/07/432/014	Netiekiama	-	-	No	-	-
103442	89544	1089544	užpildytas švirkštas	0,8 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/432/035	Netiekiama	-	-	No	-	-
103443	89545	1089545	užpildytas švirkštas	0,8 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/432/036	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas