MYLAN-ATORVASTATIN TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Beschikbaar vanaf:

MYLAN PHARMACEUTICALS ULC

ATC-code:

C10AA05

INN (Algemene Internationale Benaming):

ATORVASTATIN

Dosering:

10MG

farmaceutische vorm:

TABLET

Samenstelling:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Toedieningsweg:

ORAL

Eenheden in pakket:

90/500

Prescription-type:

Prescription

Therapeutisch gebied:

HMG-COA REDUCTASE INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0133055001; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2016-05-20

Productkenmerken

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_Page 1_
I
PRODUCT MONOGRAPH
PR
MYLAN-ATORVASTATIN
ATORVASTATIN CALCIUM TABLETS
10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN
LIPID METABOLISM REGULATOR
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
DATE OF REVISION : MAY 3, 2016
SUBMISSION CONTROL NO.: 194039
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_Page 2 _
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
............................................................................................................
11
DRUG INTERACTIONS
............................................................................................................
14
DOSAGE AND ADMINISTRATION
........................................................................................
22
OVERDOSAGE
..........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
24
STORAGE AND STABILITY
....................................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 27
PART II: SCIENTIFIC INFORMATION
..................................................................................
28
PHARMACEUTICAL INFORMATION
.......................................