ORALAIR TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GRASS POLLEN ALLERGEN EXTRACT

Available from:

STALLERGENES CANADA INC

ATC code:

V01AA02

INN (International Name):

GRASS POLLEN

Dosage:

300UNIT

Pharmaceutical form:

TABLET

Composition:

GRASS POLLEN ALLERGEN EXTRACT 300UNIT

Administration route:

SUBLINGUAL

Units in package:

28/30/90

Prescription type:

Prescription

Therapeutic area:

ALLERGENIC EXTRACTS

Product summary:

Active ingredient group (AIG) number: 0153132002; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-04-01

Summary of Product characteristics

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_Page 1 of 39_
PRODUCT MONOGRAPH
PR
ORALAIR
Grass Pollen Allergen Extract
100 IR and 300 IR Sublingual Tablets
Allergenic Substance
Stallergenes Canada Inc.
1215 North Service Road West, Suite B
Oakville, ON
L6M 2W2
Canada
Date of Preparation:
September 6, 2016
APPROVAL DATE:
NOVEMBER 18, 2016
SUBMISSION CONTROL NO: 192653
_ _
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
.................................................................................................19
DOSAGE AND
ADMINISTRATION..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
.....................................