Byooviz

Medicinal product

(Invented) name

Byooviz

Active substance (s)

Ranibizumabas

Strength

10 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

vartoti į stiklakūnį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01LA04, Ranibizumab

Marketing authorisation holder

Samsung Bioepis NL B.V., Nyderlandai

Date of authorisation

2021-08-18

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	1 ml
Ranibizumabas	10 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
107176	93280	1093280	flakonas	0,23 ml (2,3 mg), filtro adata, injekcinė adata N1		Receptinis	EU/1/21/1572/001	Netiekiama	-	-	No	-	-
107559	93664	1093664	flakonas	0,23 ml N1		Receptinis	EU/1/21/1572/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-18	Registruotas