REDDY-EVEROLIMUS TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

EVEROLIMUS

Tersedia dari:

DR REDDY'S LABORATORIES LTD

Kode ATC:

L01EG02

INN (Nama Internasional):

EVEROLIMUS

Dosis:

7.5MG

Bentuk farmasi:

TABLET

Komposisi:

EVEROLIMUS 7.5MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0152682009; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-11-01

Karakteristik produk

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