Silapo

Medicinal product

(Invented) name

Silapo

Active substance (s)

Epoetinas zeta

Strength

5000 ml/0,5 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	0.5 ml
Epoetinas zeta	5000 ml

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
28236	30766	1030766	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/07/432/009	Netiekiama	-	-	No	-	-
28237	30767	1030767	užpildytas švirkštas	0,5 ml N6		Receptinis	EU/1/07/432/010	Netiekiama	-	-	No	-	-
103438	89540	1089540	užpildytas švirkštas	0,5 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/432/031	Netiekiama	-	-	No	-	-
103439	89541	1089541	užpildytas švirkštas	0,5 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/432/032	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas