Binila

Medicinal product

(Invented) name

Binila

Active substance (s)

Bortezomibas

Strength

3,5 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XG01, bortezomib

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2018-02-26

Date of renewal

2020-06-11

Documents

4198 Pakuotės lapelis 2021_02_26.docx

4198 Binila milt inj tirp PCS PL 2021_02_26.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3176/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Bortezomibas	3,5 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
98996	85100	1085100	flakonas	N1		Receptinis	LT/1/18/4198/002	Netiekiama	-	-	No	-	-
98997	85101	1085101	flakonas	N3		Receptinis	LT/1/18/4198/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-29	Išregistruotas
2020-06-11	Perregistruotas
2018-02-26	Registruotas