MYLAN-ROSUVASTATIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

C10AA07

INN (Nama Antarabangsa):

ROSUVASTATIN

Dos:

5MG

Borang farmaseutikal:

TABLET

Komposisi:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0148963004; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2018-07-12

Ciri produk

_Page 1 of 46 _
PRODUCT MONOGRAPH
PR
MYLAN-ROSUVASTATIN
Rosuvastatin Calcium Tablets
5 mg, 10 mg, 20 mg and 40 mg
LIPID METABOLISM REGULATOR
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 205317
Date of Revision: May 11, 2017
_Page 2 of 46_
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
..................................................................................
10
DRUG INTERACTIONS
...................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................. 22
OVERDOSAGE
..................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................... 24
STORAGE AND STABILITY
..........................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING ........................... 27
PART II: SCIENTIFIC INFORMATION
............................................................... 28
PHARMACEUTICAL INFORMATION
........................................................ 28
CLINICAL TRIALS
..........................................................................................
29
DETAILED PHARMACOLOGY
.....................................................................
33
TOXICOLOGY
..................................................................................................
34
REFERENCES
...................................................................................................
40
P