Silapo

Medicinal product

(Invented) name

Silapo

Active substance (s)

Epoetinas zeta

Strength

40000 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 syringe	1 ml
Epoetinas zeta	40000 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
28248	30778	1030778	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/07/432/019	Netiekiama	-	-	No	-	-
42342	56109	1056109	užpildytas švirkštas	1 ml N4		Receptinis	EU/1/07/432/022	Netiekiama	-	-	No	-	-
103450	89552	1089552	užpildytas švirkštas	1 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/432/043	Netiekiama	-	-	No	-	-
103451	89553	1089553	užpildytas švirkštas	1 ml N4 (su adatos apsauga)		Receptinis	EU/1/07/432/044	Netiekiama	-	-	No	-	-
105394	91494	1091494	užpildytas švirkštas	1 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/432/047	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas