NTP-ROSUVASTATIN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ROSUVASTATIN (ROSUVASTATIN CALCIUM)

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

C10AA07

INN (Kansainvälinen yleisnimi):

ROSUVASTATIN

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

ROSUVASTATIN (ROSUVASTATIN CALCIUM) 10MG

Antoreitti:

ORAL

Kpl paketissa:

16/30/100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

HMG-COA REDUCTASE INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2017-06-13

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
NTP-ROSUVASTATIN
ROSUVASTATIN CALCIUM TABLETS
HOUSE STANDARD
5 MG, 10 MG, 20 MG AND 40 MG ROSUVASTATIN (ROSUVASTATIN CALCIUM)
LIPID METABOLISM REGULATOR
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
July 23, 2013
Submission Control No.: 166141
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NTP-ROSUVASTATIN Page 2 of 40
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
.......................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................
14
DOSAGE AND ADMINISTRATION
.................................................................................
17
OVERDOSAGE
....................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 20
STORAGE AND STABILITY
.............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.............................................................................
23
CLINICAL TRIALS
...............