Byooviz

Medicinal product

(Invented) name

Byooviz

Active substance (s)

Ranibizumabas

Strength

10 mg/ml

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

1 ml injekcinio tirpalo yra:	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
119893	105999	1105999	užpildytas švirkštas	0,165 ml N1		Receptinis	EU/1/21/1572/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-18	Registruotas