Bortezomib PharmaSwiss

Medicinal product

(Invented) name

Bortezomib PharmaSwiss

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

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2017-02-27

Date of renewal

Documents

4051_1-2 Bortezomib_PharmaSwiss_DC.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/1274/001/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
59098	73319	1073319	flakonas	N1		Receptinis	LT/1/17/4051/001	Netiekiama	-	-	No	-	-
67796	82353	1082353	flakonas	N1x10		Receptinis	LT/1/17/4051/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-05	Išregistruotas
2017-02-27	Registruotas