PREVIFEM (28DAY) TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
24-12-2008
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Aktiva substanser:
NORGESTIMATE; ETHINYL ESTRADIOL
Tillgänglig från:
NOVOPHARM LIMITED
ATC-kod:
G03AA11
INN (International namn):
NORGESTIMATE AND ESTROGEN
Dos:
0.25MG; 0.035MG
Läkemedelsform:
TABLET
Sammansättning:
NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG
Administreringssätt:
ORAL
Enheter i paketet:
28
Receptbelagda typ:
Prescription
Terapiområde:
CONTRACEPTIVES
Produktsammanfattning:
Active ingredient group (AIG) number: 0213627001; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2018-07-24
Produktens egenskaper
PRODUCT MONOGRAPH
PR
PREVIFEM
0.250 mg norgestimate and 0.035 mg ethinyl estradiol
Tablets
Novopharm Standard
Oral Contraceptive
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 116290
Date of Preparation:
August 20, 2007
Date of revision:
December 2, 2008
_Page 2 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS....................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE
REACTIONS....................................................................................................8
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE.................................................................................................................19
ACTION AND CLINICAL
PHARMACOLOGY.............................................................19
STORAGE AND STABILITY
..........................................................................................20
SPECIAL HANDLING
INSTRUCTIONS........................................................................20
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL
INFORMATION..........................................................................22
CLINICAL TRIALS
..................................................................................
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