SANDOZ CINACALCET TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CINACALCET (CINACALCET HYDROCHLORIDE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

H05BX01

INN (International Name):

CINACALCET

Dosage:

90MG

Pharmaceutical form:

TABLET

Composition:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2021-04-21

Summary of Product characteristics

_ _
_Sandoz Cinacalcet _
_Page 1 of 26 _
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
_ _
_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
...........................................