MYLAN-ATOMOXETINE CAPSULE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
12-01-2016

Viambatanisho vya kazi:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Inapatikana kutoka:

MYLAN PHARMACEUTICALS ULC

ATC kanuni:

N06BA09

INN (Jina la Kimataifa):

ATOMOXETINE

Kipimo:

60MG

Dawa fomu:

CAPSULE

Tungo:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 60MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30/100

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0150434005; AHFS:

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2018-07-12

Tabia za bidhaa

                                MYLAN-ATOMOXETINE Product Monograph
Page 1
PRODUCT MONOGRAPH
PR
MYLAN-ATOMOXETINE
(ATOMOXETINE CAPSULES, USP)
18 MG, 25 MG, 40 MG, 60 MG, 80 MG AND 100 MG ATOMOXETINE (AS
ATOMOXETINE HYDROCHLORIDE)
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
MYLAN PHARMACEUTICALS ULC
Date of Revision:
85 Advance Rd.
January 7, 2016
Etobicoke, On, M8Z 2S6
Canada
SUBMISSION CONTROL NO: 190331
MYLAN-ATOMOXETINE Product Monograph
Page 2
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
................................................................... 28
STORAGE AND STABILITY
........................................
                                
                                Soma hati kamili
                                
                            

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