MAVENCLAD TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CLADRIBINE

Disponível em:

EMD SERONO, A DIVISION OF EMD INC., CANADA

Código ATC:

L04AA40*

DCI (Denominação Comum Internacional):

CLADRIBINE

Dosagem:

10MG

Forma farmacêutica:

TABLET

Composição:

CLADRIBINE 10MG

Via de administração:

ORAL

Unidades em pacote:

1/4/5/6/7/8

Tipo de prescrição:

Prescription

Área terapêutica:

IMMUNOSUPPRESSIVE AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0124270002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2017-11-30

Características técnicas

_MAVENCLAD_
_®_
_ (cladribine) Product Monograph _
_Page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAVENCLAD®
Cladribine
10 mg Tablet, oral
Selective Immunosuppressant
TREATMENT WITH MAVENCLAD SHOULD BE INITIATED AND SUPERVISED BY
NEUROLOGISTS EXPERIENCED IN THE
TREATMENT OF PATIENTS WITH MS AND WHO HAVE FULLY FAMILIARIZED
THEMSELVES WITH THE EFFICACY AND
SAFETY PROFILE OF MAVENCLAD.
EMD Serono, a Division of EMD Inc., Canada
2695 North Sheridan Way, Suite 200
Mississauga, Ontario L5K 2N6
www.emdserono.ca
EMD Serono is a business of Merck KGaA, Darmstadt, Germany
Date of Initial Authorization:
November 29, 2017
Date of Revision:
October 7, 2021
Submission Control Number: 249245
MAVENCLAD is a trademark of Merck KGaA, Darmstadt, Germany or its
affiliates.
_MAVENCLAD_
_®_
_ (cladribine) Product Monograph _
_Page 2 of 39 _
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
10/2021
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic
10/2021
7 Warnings and Precautions, Immune, Hypersensitivity
10/2021
2 Contraindications
11/2020
4.1 Dosing Considerations
11/2020
7 Warnings and Precautions, General, Carcinogenesis and
Mutagenesis, Sexual Function/Reproduction
11/2020
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
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (< 18 years of
age)..............................................................................
4
1.2
Geriatrics (> 65 years of age)
..............................................................................