MAVENCLAD TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CLADRIBINE

Disponibil de la:

EMD SERONO, A DIVISION OF EMD INC., CANADA

Codul ATC:

L04AA40*

INN (nume internaţional):

CLADRIBINE

Dozare:

10MG

Forma farmaceutică:

TABLET

Compoziție:

CLADRIBINE 10MG

Calea de administrare:

ORAL

Unități în pachet:

1/4/5/6/7/8

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

IMMUNOSUPPRESSIVE AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-11-30

Caracteristicilor produsului

_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)
..............................................................................