MYLAN-ROSUVASTATIN TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
30-05-2017
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:
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
Fáanlegur frá:
MYLAN PHARMACEUTICALS ULC
ATC númer:
C10AA07
INN (Alþjóðlegt nafn):
ROSUVASTATIN
Skammtar:
5MG
Lyfjaform:
TABLET
Samsetning:
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
HMG-COA REDUCTASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0148963004; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2018-07-12
Vara einkenni
_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
Lestu allt skjalið
