REDDY-EVEROLIMUS TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

EVEROLIMUS

Dostopno od:

DR REDDY'S LABORATORIES LTD

Koda artikla:

L01EG02

INN (mednarodno ime):

EVEROLIMUS

Odmerek:

5MG

Farmacevtska oblika:

TABLET

Sestava:

EVEROLIMUS 5MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2022-11-01

Lastnosti izdelka

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