Bortezomib STADA

Medicinal product

(Invented) name

Bortezomib STADA

Active substance (s)

Bortezomibas

Strength

2,5 mg/ml

Pharmaceutical form

injekcinis tirpalas

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2022-04-22

Date of renewal

2023-06-08

Documents

4947_pakuotes lapelis_2023-06-08.docx

4947 Bortezomib STADA PCS 2024 12 24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/3938/001/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	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
108525	94629	1094629	flakonas	1,4 ml N1		Receptinis	LT/1/22/4947/001	Netiekiama	-	-	No	-	-
108705	94811	1094811	flakonas	2,8 ml N1		Receptinis	LT/1/22/4947/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-06-08	Perregistruotas
2022-04-22	Registruotas