ADDYI TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLIBANSERIN

Available from:

SEARCHLIGHT PHARMA INC

ATC code:

G02CX02

INN (International Name):

FLIBANSERIN

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

FLIBANSERIN 100MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Product summary:

Active ingredient group (AIG) number: 0160010001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-10-02

Summary of Product characteristics

_Product Monograph _
_ _
_ADDYI_
_TM_
_ Flibanserin _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ADDYI
TM
Flibanserin
Tablets, 100 mg, Oral
Central Nervous System Agent
AHFS code 28:92
ATC code G02CX02
Searchlight Pharma Inc.
1600 Notre-Dame Street W. Suite 312
Montreal, QC
H3J 1M1
Date of Initial Authorization:
FEB 27, 2018
Date of Revision:
JAN 26, 2021
Submission Control Number: 229727
_ _
_Product Monograph _
_ _
_ADDYI (flibanserin) _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
1 Indications, 2 Contraindications, 3 Serious Warnings and
Precautions Box, 4 Dosage and Administration, 7 Warnings and
Precautions, 8 Adverse Reactions, 14 Clinical Trials
01/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
......................................................................................................
2
TABLE OF CONTENTS
........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................................
4
1
INDICATIONS AND CLINICAL USE
..........................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................
5
4
DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.1
Dosing Considerations
.........................................................................................................
5
4.2
Recommended Dose and