REDDY-EVEROLIMUS TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

EVEROLIMUS

Disponível em:

DR REDDY'S LABORATORIES LTD

Código ATC:

L01EG02

DCI (Denominação Comum Internacional):

EVEROLIMUS

Dosagem:

5MG

Forma farmacêutica:

TABLET

Composição:

EVEROLIMUS 5MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Resumo do produto:

Active ingredient group (AIG) number: 0152682001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2022-11-01

Características técnicas

_Reddy-Everolimus Product Monograph _
_Page 1 of 87 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
REDDY-EVEROLIMUS
Everolimus Tablets
2.5 mg, 5 mg, 7.5 mg and 10 mg, Oral
Protein Kinase Inhibitors
ATC Code: L01XE10
Manufactured By:
DR. REDDY’S LABORATORIES LTD.,
Bachupally – 500 090 India
Imported and Distributed By:
DR. REDDY'S LABORATORIES CANADA INC.
Mississauga ON L4W 4Y1 Canada
Date of Initial Authorization:
October 27, 2022
Submission Control Number: 250101
_Reddy-Everolimus Product Monograph _
_Page 2 of 87 _
RECENT MAJOR LABEL CHANGES
None at time of authorization.
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.......................................................................................................................................5
1.2
GERIATRICS
.......................................................................................................................................5
2
CONTRAINDICATIONS
.....................................................................................................................6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................................6
4
DOSAGE AND ADMINISTRATION
....................................................................................................7
4.1
DOSING
CONSIDERATIONS.......................................................................