APO-DIPYRIDAMOLE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DIPYRIDAMOLE

Tersedia dari:

APOTEX INC

Kode ATC:

B01AC07

INN (Nama Internasional):

DIPYRIDAMOLE

Dosis:

25MG

Bentuk farmasi:

TABLET

Komposisi:

DIPYRIDAMOLE 25MG

Rute administrasi :

ORAL

Unit dalam paket:

250ML

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS VASODILATATING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0106621001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-08-12

Karakteristik produk

Page 1 of 18
PRODUCT MONOGRAPH
PR
APO-DIPYRIDAMOLE
DIPYRIDAMOLE TABLETS USP
25, 50, 75 AND 100 MG
PR
APO-DIPYRIDAMOLE-SC
DIPYRIDAMOLE SUGAR-COATED TABLETS USP
25, 50 AND 75 MG
CORONARY VASODILATOR
INHIBITOR OF PLATELET ADHESION AND AGGREGATION
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9
AUGUST 10, 2021
CONTROL NUMBER: 246833
Page 2 of 18
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT
INFORMATION......................................................................................
3
INDICATIONS AND CLINICAL USES
.........................................................................................
3
CONTRAINDICATIONS
.............................................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................................
3
ADVERSE
REACTIONS.............................................................................................................
4
DRUG INTERACTIONS
.............................................................................................................
5
DOSAGE AND ADMINISTRATION
.............................................................................................
6
OVERDOSAGE..........................................................................................................................
6
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................
6
STORAGE AND STABILITY
.......................................................................................................
7
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................................. 7
PART II: SCIENTIFIC INFORMATION
...........................................................................................
9
PHARMACEUTICAL INFORMATION
.............................................