PREVIFEM (21DAY) TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
24-12-2008
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Aktívna zložka:
NORGESTIMATE; ETHINYL ESTRADIOL
Dostupné z:
NOVOPHARM LIMITED
ATC kód:
G03AA11
INN (Medzinárodný Name):
NORGESTIMATE AND ESTROGEN
Dávkovanie:
0.25MG; 0.035MG
Forma lieku:
TABLET
Zloženie:
NORGESTIMATE 0.25MG; ETHINYL ESTRADIOL 0.035MG
Spôsob podávania:
ORAL
Počet v balení:
21
Typ predpisu:
Prescription
Terapeutické oblasti:
CONTRACEPTIVES
Prehľad produktov:
Active ingredient group (AIG) number: 0213627001; AHFS:
Stav Autorizácia:
CANCELLED PRE MARKET
Dátum Autorizácia:
2018-07-24
Súhrn charakteristických
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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