REDDY-EVEROLIMUS TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

EVEROLIMUS

Dostępny od:

DR REDDY'S LABORATORIES LTD

Kod ATC:

L01EG02

INN (International Nazwa):

EVEROLIMUS

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

EVEROLIMUS 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2022-11-01

Charakterystyka produktu

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