TRI-PREVIFEM (21 DAY) TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL; NORGESTIMATE; ETHINYL ESTRADIOL

Dostępny od:

NOVOPHARM LIMITED

Kod ATC:

G03AB

INN (International Nazwa):

PROGESTOGENS AND ESTROGENS, SEQUENTIAL PREPARATIONS

Dawkowanie:

0.180MG; 0.035MG; 0.215MG; 0.035MG; 0.250MG; 0.035MG

Forma farmaceutyczna:

TABLET

Skład:

NORGESTIMATE 0.180MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.215MG; ETHINYL ESTRADIOL 0.035MG; NORGESTIMATE 0.250MG; ETHINYL ESTRADIOL 0.035MG

Droga podania:

ORAL

Sztuk w opakowaniu:

21

Typ recepty:

Prescription

Dziedzina terapeutyczna:

CONTRACEPTIVES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0636783002; AHFS:

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2018-07-24

Charakterystyka produktu

_Page 1_
PRODUCT MONOGRAPH
PR
TRI-PREVIFEM
0.180 mg norgestimate and 0.035 mg ethinyl estradiol
0.215 mg norgestimate and 0.035 mg ethinyl estradiol
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: 116255
Date of Preparation:
January 31, 2005
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
.................................................................................................
11
DOSAGE AND
ADMINISTRATION.............................................................................
17
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND
STABILITY.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.............................................................