Silapo

Medicinal product

(Invented) name

Silapo

Active substance (s)

Epoetinas zeta

Strength

30000 TV/0,75 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	0.75 ml
Epoetinas zeta	30000 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
28247	30777	1030777	užpildytas švirkštas	0,75 ml N1		Receptinis	EU/1/07/432/018	Netiekiama	-	-	No	-	-
42341	56108	1056108	užpildytas švirkštas	0,75 ml N4		Receptinis	EU/1/07/432/021	Netiekiama	-	-	No	-	-
103448	89550	1089550	užpildytas švirkštas	0,75 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/432/041	Netiekiama	-	-	No	-	-
103449	89551	1089551	užpildytas švirkštas	0,75 ml N4 (su adatos apsauga)		Receptinis	EU/1/07/432/042	Netiekiama	-	-	No	-	-
105393	91493	1091493	užpildytas švirkštas	0,75 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/432/046	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas