NATAZIA TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST; ESTRADIOL VALERATE; DIENOGEST; ESTRADIOL VALERATE

Dostupno od:

BAYER INC

ATC koda:

G03AB08

INN (International ime):

DIENOGEST AND ESTROGEN

Doziranje:

3MG; 2MG; 2MG; 2MG; 3MG; 1MG

Farmaceutski oblik:

TABLET

Sastav:

ESTRADIOL VALERATE 3MG; ESTRADIOL VALERATE 2MG; DIENOGEST 2MG; ESTRADIOL VALERATE 2MG; DIENOGEST 3MG; ESTRADIOL VALERATE 1MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

CONTRACEPTIVES

Proizvod sažetak:

Active ingredient group (AIG) number: 0653087001; AHFS:

Status autorizacije:

CANCELLED PRE MARKET

Datum autorizacije:

2023-07-10

Svojstava lijeka

_ _
_NATAZIA Product Monograph_
_Page 1 of 58 _
PRODUCT MONOGRAPH
PR
NATAZIA
®
estradiol valerate tablets, and estradiol valerate and dienogest
tablets
3.0 mg estradiol valerate tablets
2.0 mg estradiol valerate and 2.0 mg dienogest tablets
2.0 mg estradiol valerate and 3.0 mg dienogest tablets
1.0 mg estradiol valerate tablets
Oral Contraceptive
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Revision:
August 19, 2019
Submission Control No: 228479
© 2019 Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_NATAZIA Product Monograph_
_Page 2 of 58 _
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
.................................................................................................
14
DRUG
INTERACTIONS..................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 27
STORAGE AND STABILITY
.........................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 31
PART II: SCI