ANGELIQ TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DROSPIRENONE; ESTRADIOL

Tersedia dari:

BAYER INC

Kode ATC:

G03FA17

INN (Nama Internasional):

DROSPIRENONE AND ESTROGEN

Dosis:

1.0MG; 1.0MG

Bentuk farmasi:

TABLET

Komposisi:

DROSPIRENONE 1.0MG; ESTRADIOL 1.0MG

Rute administrasi :

ORAL

Unit dalam paket:

28

Jenis Resep:

Prescription

Area terapi:

PROGESTINS

Ringkasan produk:

Active ingredient group (AIG) number: 0251181001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2005-07-08

Karakteristik produk

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_Page 1 of 47 _
PRODUCT MONOGRAPH
PR
ANGELIQ
®
Drospirenone and Estradiol-17β tablet
1/1 mg
Progestin – Estrogen
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Revision:
February 17, 2016
Submission Control No: 189314
© 2016, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_Page 2 of 47 _
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
................................................................................28
PHARMACEUTICAL INFORMATION
..........................................................................28
CLINICAL TRIALS
..........................................................................................................30
DETAILED PHARMACOLOGY
..........