Retacrit

Medicinal product

(Invented) name

Retacrit

Active substance (s)

Epoetinas zeta

Strength

5000 TV/0,5 ml

Pharmaceutical form

injekcinis tirpalas

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

Pfizer Europe MA EEIG, Belgija

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	0.5 ml
Epoetinas zeta	5000 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
28144	30680	1030680	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/07/431/009	Netiekiama	-	-	No	-	-
28145	30681	1030681	užpildytas švirkštas	0,5 ml N6		Receptinis	EU/1/07/431/010	Tiekiama	-	-	No	-	-
66732	81269	1081269	užpildytas švirkštas	0,5 ml N1 (su adatos apsauga)		Receptinis	EU/1/07/431/034	Netiekiama	-	-	No	-	-
66733	81270	1081270	užpildytas švirkštas	0,5 ml N6 (su adatos apsauga)		Receptinis	EU/1/07/431/035	Netiekiama	-	-	No	-	-
68691	83274	1083274	užpildytas švirkštas	0,5 ml N1 (su adatos gaubteliu)		Receptinis	EU/1/07/431/062	Netiekiama	-	-	No	-	-
68692	83275	1083275	užpildytas švirkštas	0,5 ml N6 (su adatos gaubteliu)		Receptinis	EU/1/07/431/063	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-12-18	Registruotas