VENCLEXTA TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

VENETOCLAX

Disponible des:

ABBVIE CORPORATION

Codi ATC:

L01XX52

Designació comuna internacional (DCI):

VENETOCLAX

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

VENETOCLAX 10MG

Vía de administración:

ORAL

Unidades en paquete:

2/14

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0158490001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2016-09-30

Fitxa tècnica

_VENCLEXTA (venetoclax) _
_Date of Revision: APR 05, 2022 _
_Submission Control No.: 253017 _
_Page 1 of 85 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VENCLEXTA®
venetoclax tablets
Tablets, 10 mg, 50 mg and 100 mg, oral
Other Antineoplastic Agent (ATC Code: L01XX52)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Qc H4S 1Z1
Date of Initial Authorization:
SEP 27, 2016
Date of Revision:
APR 05, 2022
Submission Control Number: 253017
_VENCLEXTA (venetoclax) _
_Date of Revision: APR 05, 2022 _
_Submission Control No.: 253017 _
_Page 2 of 85 _
RECENT MAJOR LABEL CHANGES
1 Indications
12/2020
1 Indications, 1.2 Geriatrics
04/2020
3 Serious Warnings and Precautions Box
12/2020
4 Dosage and Administration, 4.1 Dosing Considerations
12/2020
4 Dosage and Administration, 4.2 Recommended Dose and Dose
Adjustment
12/2020
7 Warnings and Precautions, Carcinogenesis and Mutagenesis
01/2020
7 Warnings and Precautions, Endocrine and Metabolism
12/2020
7 Warnings and Precautions, Hematologic
12/2020
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic
01/2020
7 Warnings and Precautions, Immune
12/2020
7 Warnings and Precautions, Renal
01/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 5
1
INDICATIONS
.............................................................................................................
5
1.1
Pediatrics
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICAT