MYLAN-ROSUVASTATIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
30-05-2017
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
ROSUVASTATIN (ROSUVASTATIN CALCIUM)
Inapatikana kutoka:
MYLAN PHARMACEUTICALS ULC
ATC kanuni:
C10AA07
INN (Jina la Kimataifa):
ROSUVASTATIN
Kipimo:
20MG
Dawa fomu:
TABLET
Tungo:
ROSUVASTATIN (ROSUVASTATIN CALCIUM) 20MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30/100/500
Dawa ya aina:
Prescription
Eneo la matibabu:
HMG-COA REDUCTASE INHIBITORS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0148963002; AHFS:
Idhini hali ya:
CANCELLED POST MARKET
Idhini ya tarehe:
2018-07-12
Tabia za bidhaa
_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
Soma hati kamili
