MYLAN-ATORVASTATIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ATORVASTATIN (ATORVASTATIN CALCIUM)

Dostopno od:

MYLAN PHARMACEUTICALS ULC

Koda artikla:

C10AA05

INN (mednarodno ime):

ATORVASTATIN

Odmerek:

10MG

Farmacevtska oblika:

TABLET

Sestava:

ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG

Pot uporabe:

ORAL

Enote v paketu:

90/500

Tip zastaranja:

Prescription

Terapevtsko območje:

HMG-COA REDUCTASE INHIBITORS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2016-05-20

Lastnosti izdelka

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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
.......................................