Opuviz

Medicinal product

(Invented) name

Opuviz

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

Samsung Bioepis NL B.V., Nyderlandai

Date of authorisation

2024-11-13

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

1 ml tirpalo yra:	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
115874	101979	1101979	flakonas	0,1 ml N1		Receptinis	EU/1/24/1865/001	Nepradėtas tiekti	-	-	No	-	-
115875	101980	1101980	flakonas	0,1 ml ir 18G filtro adata N1		Receptinis	EU/1/24/1865/002	Nepradėtas tiekti	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-13	Registruotas