Yesafili

Medicinal product

(Invented) name

Yesafili

Active substance (s)

Afliberceptas

Strength

40 mg/ml

Pharmaceutical form

injekcinis tirpalas flakone

Route (s) of administration

vartoti į stiklakūnį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01LA05, Aflibercept

Marketing authorisation holder

Biosimilar Collaborations Ireland Limited, Airija

Date of authorisation

2023-09-15

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 a vial	1 ml
Afliberceptas	40 mg

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
111689	97802	1097802	flakonas	0,1 ml, 5 µm filtro adata (18 G×1½) N1		Receptinis	EU/1/23/1751/001	Netiekiama	-	-	No	-	-
111690	97803	1097803	flakonas	0,1 ml, 5 µm filtro adata (18 G × 1½), Luer-lock švirkštas (1 ml) ir injekcinė adata (30 G × ½) N1		Receptinis	EU/1/23/1751/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas