Zefylti

Medicinal product

(Invented) name

Zefylti

Active substance (s)

Filgrastimas

Strength

48 MV/0,5 ml

Pharmaceutical form

injekcinis ar infuzinis 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)

L03AA02, Filgrastim

Marketing authorisation holder

CuraTeQ Biologics s.r.o, Čekija

Date of authorisation

2025-02-12

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

Užpildytame švirkšte (0,5 ml) tirpalo yra:	0.5 ml
Filgrastimas	48 MV

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
116647	102746	1102746	užpildytas švirkštas	N1 (su adatos apsauga)		Receptinis	EU/1/24/1899/005	Netiekiama	-	-	No	-	-
116648	102747	1102747	užpildytas švirkštas	N5 (su adatos apsauga)		Receptinis	EU/1/24/1899/006	Netiekiama	-	-	No	-	-
116649	102748	1102748	užpildytas švirkštas	N1 (be adatos apsaugos)		Receptinis	EU/1/24/1899/007	Netiekiama	-	-	No	-	-
116650	102749	1102749	užpildytas švirkštas	N5 (be adatos apsaugos)		Receptinis	EU/1/24/1899/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-12	Registruotas