MYLAN-ATORVASTATIN TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
11-05-2016
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Fáanlegur frá:
MYLAN PHARMACEUTICALS ULC
ATC númer:
C10AA05
INN (Alþjóðlegt nafn):
ATORVASTATIN
Skammtar:
80MG
Lyfjaform:
TABLET
Samsetning:
ATORVASTATIN (ATORVASTATIN CALCIUM) 80MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
90
Gerð lyfseðils:
Prescription
Lækningarsvæði:
HMG-COA REDUCTASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0133055004; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2016-05-20
Vara einkenni
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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
.......................................
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