Țară: Canada
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Sursă: Health Canada
NICOTINE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
N07BA01
NICOTINE
25MG
PATCH
NICOTINE 25MG
TRANSDERMAL
7 X 22.5 SQUARE CM
Prescription
MISCELLANEOUS AUTONOMIC DRUGS
Active ingredient group (AIG) number: 0111483017; AHFS:
CANCELLED PRE MARKET
2016-01-22
PRODUCT MONOGRAPH Pr NICORETTE ® INVISIPATCH™ Nicotine Transdermal System 25 mg nicotine/ 16 hours Mfr. Std. Stop Smoking Aid McNeil Consumer Healthcare, division of Johnson & Johnson Inc. 88 McNabb Street Markham, ON L3R 5L2 DATE OF PREPARATION: FEBRUARY 1, 2011 SUBMISSION CONTROL NO: 127621 2 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....................................................................................................7 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION..............................................................................14 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY..........................................................................................20 SPECIAL HANDLING INSTRUCTIONS .......................................................................20 DOSAGE FORM, COMPOSITION AND PACKAGING ...............................................20 PART II: SCIENTIFIC INFORMATION ...............................................................................22 PHARMACEUTICAL INFORMATION..........................................................................22 DETAILED PHARMACOLOGY.....................................................................................25 REFERENCES ................................................................................................................ Citiți documentul complet