SANDOZ CINACALCET TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CINACALCET (CINACALCET HYDROCHLORIDE)

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

H05BX01

INN (International Name):

CINACALCET

Dosering:

90MG

Lægemiddelform:

TABLET

Sammensætning:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30

Recept type:

Prescription

Terapeutisk område:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produkt oversigt:

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

Autorisation status:

CANCELLED PRE MARKET

Autorisation dato:

2021-04-21

Produktets egenskaber

_ _
_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
...........................................