TEVA-EVEROLIMUS TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

EVEROLIMUS

متاح من:

TEVA CANADA LIMITED

ATC رمز:

L01EG02

INN (الاسم الدولي):

EVEROLIMUS

جرعة:

7.5MG

الشكل الصيدلاني:

TABLET

تركيب:

EVEROLIMUS 7.5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANTINEOPLASTIC AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2019-12-06

خصائص المنتج

_TEVA-EVEROLIMUS_
_ _
Page 1 of 102
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-EVEROLIMUS
Everolimus Tablets
Tablets, 2.5 mg, 5 mg, 7.5 mg and 10 mg, Oral
Protein Kinase Inhibitor
ATC Code: L01XE10
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
December 06, 2019
Date of Revision:
March 07, 2022
Submission Control Number: 257223
_TEVA-EVEROLIMUS_
_ _
Page 2 of 102
RECENT MAJOR LABEL CHANGES
7 Warning and Precautions, Radiation Sensitization and Radiation
Recall
03/2022
1 Indications, 1.1 Pediatrics
03/2022
3 Serious Warnings and Precautions Box
03/2022
4 Dosage and Administration, 4.1 Dosing Considerations
03/2022
4 Dosage and Administration, 4.4 Administration
03/2022
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
......................................................................................................................
6
2 CONTRAINDICATIONS
....................................................................................................
6
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 6
4 DOSAGE AND ADMINISTRATION
....................................................................................
7
4.1 Dosing Considerations
.............................................