RATIO-ATOMOXETINE CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

متاح من:

TEVA CANADA LIMITED

ATC رمز:

N06BA09

INN (الاسم الدولي):

ATOMOXETINE

جرعة:

25MG

الشكل الصيدلاني:

CAPSULE

تركيب:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 25MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

ملخص المنتج:

Active ingredient group (AIG) number: 0150434003; AHFS:

الوضع إذن:

CANCELLED PRE MARKET

تاريخ الترخيص:

2015-10-16

خصائص المنتج

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PRODUCT MONOGRAPH
PR
RATIO-ATOMOXETINE
Atomoxetine Hydrochloride Capsules
10mg, 18mg, 25mg, 40mg and 60mg atomoxetine (as atomoxetine
hydrochloride)
Selective Norepinephrine Reuptake Inhibitor for
Attention-Deficit/Hyperactivity
Disorder (ADHD)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision :
May 31, 2012
SUBMISSION CONTROL NO.: 153586
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................. 3
INDICATIONS AND CLINICAL USE
.................................................................... 3
Special Diagnostic Considerations
............................................................................
3
Need for Comprehensive Treatment Program
........................................................... 4
CONTRAINDICATIONS
.........................................................................................
4
WARNINGS AND PRECAUTIONS
........................................................................
5
ADVERSE REACTIONS
........................................................................................
12
DRUG ABUSE AND DEPENDENCE
................................................................... 21
DRUG INTERACTIONS
........................................................................................
22
DOSAGE AND ADMINISTRATION
....................................................................
24
OVERDOSAGE
......................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
.................................................. 27
STORAGE AND STABILITY
................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 32