SAPHRIS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ASENAPINE (ASENAPINE MALEATE)

Available from:

ORGANON CANADA INC.

ATC code:

N05AH05

INN (International Name):

ASENAPINE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

ASENAPINE (ASENAPINE MALEATE) 5MG

Administration route:

SUBLINGUAL

Units in package:

20/60

Prescription type:

Prescription

Therapeutic area:

ATYPICAL ANTIPSYCHOTICS

Product summary:

Active ingredient group (AIG) number: 0153020001; AHFS:

Authorization status:

APPROVED

Authorization date:

2011-10-07

Summary of Product characteristics

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_SAPHRIS_
_®_
_ (asenapine sublingual tablets) _
_Page 1 of 49_
PRODUCT MONOGRAPH
SAPHRIS
®
(asenapine sublingual tablets)
5 mg and 10 mg asenapine, as asenapine maleate
Antipsychotic
Manufactured by:
Organon Canada Inc.
16766 route Transcanadienne
Kirkland, Quebec
H9H 4M7
Date of Revision:
April 27, 2021
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SUBMISSION CONTROL NO.: 250558
_ _
_SAPHRIS_
_®_
_ (asenapine sublingual tablets) _
_Page 2 of 49_
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................25
DOSAGE AND ADMINISTRATION
..............................................................................27
OVERDOSAGE
................................................................................................................28
ACTION AND CLINICAL PHARMACOLOGY
............................................................29
STORAGE AND STABILITY
..........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
................................................................................32
PHARMACEUTICAL INFORMATION
..........................................................................32
CLINICAL TRIALS
.................................................................