SANDOZ ENTECAVIR TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ENTECAVIR

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

J05AF10

INN (Kansainvälinen yleisnimi):

ENTECAVIR

Annos:

0.5MG

Lääkemuoto:

TABLET

Koostumus:

ENTECAVIR 0.5MG

Antoreitti:

ORAL

Kpl paketissa:

30/1000

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NUCLEOSIDES AND NUCLEOTIDES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0151648001; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2021-04-21

Valmisteyhteenveto

_Sandoz Entecavir _
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
SANDOZ ENTECAVIR
Entecavir Tablets
0.5 mg
Antiviral
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Revision:
October 24, 2018
Submission Control No: 220844
_Sandoz Entecavir _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
CLINICAL TRIALS
.........................................................................................................
20
DETAILED PHARMACOLOGY
................................................................................