BICALUTAMIDE TABLETS

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BICALUTAMIDE

متاح من:

FRESENIUS KABI CANADA LTD

ATC رمز:

L02BB03

INN (الاسم الدولي):

BICALUTAMIDE

جرعة:

50MG

الشكل الصيدلاني:

TABLET

تركيب:

BICALUTAMIDE 50MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

10/30

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANTINEOPLASTIC AGENTS

ملخص المنتج:

Active ingredient group (AIG) number: 0127996001; AHFS:

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2023-03-10

خصائص المنتج

PRODUCT MONOGRAPH PR
BICALUTAMIDE TABLETS
bicalutamide
50 mg
USP
Non-Steroidal Antiandrogen
FRESENIUS KABI CANADA LTD. DATE OF REVISION:
165 Galaxy Blvd, Suite 100 October 17, 2017
Toronto, ON, M9W 0C8
SUBMISSION CONTROL NO. 209416
Bicalutamide Tablets – Product Monograph
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
................................................................................................
8
DRUG INTERACTIONS
..............................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................
13
OVERDOSAGE
............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 14
STORAGE AND STABILITY
......................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 15
PART II: SCIENTIFIC INFORMATION
............................................................................
16
PHARMACEUTICAL INFORMATION
......................................................................
16
CLINICAL TRIALS
......................................................................................................
16
DETAILED PHARMACOLOGY
.................................................................................
19
TOXICOLOGY
....