Vortemyel

Medicinal product

(Invented) name

Vortemyel

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)

L01XX32, Bortezomib

Marketing authorisation holder

Alvogen IPCo S.a.r.l., Liuksemburgas

Date of authorisation

2015-07-02

Date of renewal

Documents

3761_1 Pakuotės lapelis 190319.docx

3761_1 Vortemyel milt inj PCS PL 190319.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3175/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename 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
59054	73275	1073275	flakonas	N1		Receptinis	LT/1/15/3761/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-11	Išregistruotas
2015-07-02	Registruotas