ALPRAZOLAM TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ALPRAZOLAM

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

N05BA12

INN (Nama Internasional):

ALPRAZOLAM

Dosis:

0.25MG

Bentuk farmasi:

TABLET

Komposisi:

ALPRAZOLAM 0.25MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500/1000

Jenis Resep:

Targeted (CDSA IV)

Area terapi:

BENZODIAZEPINES

Ringkasan produk:

Active ingredient group (AIG) number: 0115008001; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2022-09-30

Karakteristik produk

Page 1 of 39
PRODUCT MONOGRAPH JAMP ALPRAZOLAM
0.25 MG, 0.5 MG, 1 MG AND 2 MG
ALPRAZOLAM TABLETS, USP
ANXIOLYTIC – ANTIPANIC
JAMP Pharma Corporation Date of Preparation: September 9, 2020
1310 rue Nobel
Boucherville, Quebec
J4B 5H3
SUBMISSION CONTROL NO.: 238480
Page 2 of 39
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................... 3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
5
WARNINGS AND PRECAUTIONS
............................................................................................
5
ADVERSE REACTIONS
............................................................................................................
12
DRUG INTERACTIONS
............................................................................................................
16
DOSAGE AND ADMINISTRATION
........................................................................................
19
OVERDOSAGE
...........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
21
STORAGE AND STABILITY
....................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 22
PART II: SCIENTIFIC INFORMATION
......................................................................
24
PHARMACEUTICAL INFORMATION
....................................................................................
24
CLINICAL TRIALS
..........................................................................................