SANDOZ CINACALCET TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CINACALCET (CINACALCET HYDROCHLORIDE)

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

H05BX01

INN (שם בינלאומי):

CINACALCET

כמות:

90MG

טופס פרצבטיות:

TABLET

הרכב:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30

סוג מרשם:

Prescription

איזור תרפויטי:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0150282003; AHFS:

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2021-04-21

מאפייני מוצר

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_Sandoz Cinacalcet _
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PRODUCT MONOGRAPH
PR
SANDOZ CINACALCET
Cinacalcet Tablets
30 mg, 60 mg and 90 mg cinacalcet (as cinacalcet hydrochloride)
Calcimimetic agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of revision:
December 9, 2019
Submission Control No: 234104
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_Sandoz Cinacalcet _
_Page 2 of 26 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
...............................................................................................
8
DRUG INTERACTIONS
.............................................................................................
11
DOSAGE AND ADMINISTRATION
..........................................................................
12
OVERDOSAGE
...........................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 14
STORAGE AND STABILITY
.....................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 15
PART II: SCIENTIFIC INFORMATION
...........................................................................
16
PHARMACEUTICAL INFORMATION
......................................................................
16
CLINICAL TRIALS
.....................................................................................................
17
DETAILED PHARMACOLOGY
...........................................