JAMP ATOMOXETINE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

N06BA09

INN (Nama Internasional):

ATOMOXETINE

Dosis:

60MG

Bentuk farmasi:

CAPSULE

Komposisi:

ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 60MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-10-20

Karakteristik produk

JAMP ATOMOXETINE
Product Monograph
Page 1
PRODUCT MONOGRAPH
PR
JAMP ATOMOXETINE
Atomoxetine Capsules
10, 18, 25, 40, 60, 80 and 100 mg atomoxetine (as atomoxetine
hydrochloride)
House standard
SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR
FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Québec
J4B 5H3
Date of Approval:
October 19, 2020
Submission Control No 235031
JAMP ATOMOXETINE
Product Monograph
Page 2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................
5
ADVERSE REACTIONS
.............................................................................................
12
DRUG ABUSE AND DEPENDENCE
.........................................................................
22
DRUG INTERACTIONS
..............................................................................................
23
DOSAGE AND ADMINISTRATION
..........................................................................
24
OVERDOSAGE
............................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 28
STORAGE AND STABILITY
.....................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 33
PART II: SCIENTIFIC INFORMATION
.........................................................................
34
PHARMACEUTICAL INFORMATION
........................................................