REDDY-EVEROLIMUS TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

EVEROLIMUS

Disponibil de la:

DR REDDY'S LABORATORIES LTD

Codul ATC:

L01EG02

INN (nume internaţional):

EVEROLIMUS

Dozare:

2.5MG

Forma farmaceutică:

TABLET

Compoziție:

EVEROLIMUS 2.5MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Rezumat produs:

Active ingredient group (AIG) number: 0152682003; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-11-01

Caracteristicilor produsului

_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.......................................................................