Bortezomib Accord

Medicinal product

(Invented) name

Bortezomib Accord

Active substance (s)

Bortezomibas

Strength

2,5 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XG01, bortezomib

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2015-07-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Bortezomibas	2,5 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
107028	93131	1093131	flakonas	1 ml N1		Receptinis	EU/1/15/1019/003	Netiekiama	-	-	No	-	-
107029	93132	1093132	flakonas	1 ml N4		Receptinis	EU/1/15/1019/004	Netiekiama	-	-	No	-	-
107030	93133	1093133	flakonas	1,4 ml N1		Receptinis	EU/1/15/1019/005	Netiekiama	2025-01-01	2025-09-30	Yes	2025-01-01	2025-12-31
107031	93134	1093134	flakonas	1,4 ml N4		Receptinis	EU/1/15/1019/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-07-20	Registruotas