SANDOZ CINACALCET TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CINACALCET (CINACALCET HYDROCHLORIDE)

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

H05BX01

INN (nume internaţional):

CINACALCET

Dozare:

90MG

Forma farmaceutică:

TABLET

Compoziție:

CINACALCET (CINACALCET HYDROCHLORIDE) 90MG

Calea de administrare:

ORAL

Unități în pachet:

30

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

CANCELLED PRE MARKET

Data de autorizare:

2021-04-21

Caracteristicilor produsului

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