ADVIL MIGRAINE EXTRA STRENGTH TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)

Saatavilla:

PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC

ATC-koodi:

M01AE01

INN (Kansainvälinen yleisnimi):

IBUPROFEN

Annos:

400MG

Lääkemuoto:

TABLET

Koostumus:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 400MG

Antoreitti:

ORAL

Kpl paketissa:

12/20/30/60/67/77/180

Prescription tyyppi:

OTC

Terapeuttinen alue:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0108883002; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2018-08-02

Valmisteyhteenveto

_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 1 of 67 _
PRODUCT MONOGRAPH
ADVIL
®
MIGRAINE CAPLETS
200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
MIGRAINE TABLETS
200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
MIGRAINE EXTRA STRENGTH
400 mg Ibuprofen Caplets (provided as 512 mg Ibuprofen Sodium
Dihydrate)
Analgesic/Antipyretic
Pfizer Consumer Healthcare, a division of Pfizer Canada Inc.
450 – 55 Standish Court
Mississauga, Ontario
Canada L5R 4B2
Submission Control No.: 206595
Date of Preparation:
May 12, 2015
Date of Revision :
August 11, 2017
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................20
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND STABILITY
..........................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.............................................