MYLAN-ROSUVASTATIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Disponible depuis:

MYLAN PHARMACEUTICALS ULC

Code ATC:

C10AA07

DCI (Dénomination commune internationale):

ROSUVASTATIN

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

Mode d'administration:

ORAL

Unités en paquet:

30/100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HMG-COA REDUCTASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0148963001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2018-04-10

Résumé des caractéristiques du produit

_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