NASONEX SPRAY, METERED DOSE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-03-2022
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Active ingredient:
MOMETASONE FUROATE
Available from:
ORGANON CANADA INC.
ATC code:
R01AD09
INN (International Name):
MOMETASONE
Dosage:
50MCG
Pharmaceutical form:
SPRAY, METERED DOSE
Composition:
MOMETASONE FUROATE 50MCG
Administration route:
NASAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
CORTICOSTEROIDS
Product summary:
Active ingredient group (AIG) number: 0121732002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-05-12
Summary of Product characteristics
_ _
_NASONEX_
®
_ (mometasone furoate monohydrate aqueous _
_nasal spray) _
_Page 1 of 28 _
PRODUCT MONOGRAPH
NASONEX
®
mometasone furoate monohydrate aqueous nasal spray
50 mcg/metered spray (as mometasone furoate)
Organon standard
CORTICOSTEROID
ORGANON CANADA INC.
Date of Initial Authorization:
16766 route Transcanadienne
September 15, 1998
Kirkland, QC Canada
H9H 4M7
www.Organon.ca
Date of Revision:
March 21, 2022
Submission
Control No. 256864
_ _
_NASONEX_
®
_ (mometasone furoate monohydrate aqueous _
_nasal spray) _
_Page 2 of 28 _
RECENT MAJOR LABEL CHANGES
INDICATIONS
03/2022
DOSAGE AND ADMINISTRATION
03/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS.............................................................................................................3
CONTRAINDICATIONS
.............................................................................................4
WARNINGS AND PRECAUTIONS
.............................................................................4
ADVERSE
REACTIONS..............................................................................................6
DRUG INTERACTIONS
..............................................................................................8
DOSAGE AND ADMINISTRATION
...........................................................................8
OVERDOSAGE
.........................................................................................................
10
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
10
STORAGE AND STABILITY
....................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 12
PART II: SCIENTIFIC I
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