LOLO TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL

Dostępny od:

ABBVIE CORPORATION

Kod ATC:

G03AB04

INN (International Nazwa):

NORETHISTERONE AND ESTROGEN

Dawkowanie:

1MG; 10MCG; 10MCG

Forma farmaceutyczna:

TABLET

Skład:

NORETHINDRONE ACETATE 1MG; ETHINYL ESTRADIOL 10MCG; ETHINYL ESTRADIOL 10MCG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

CONTRACEPTIVES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0355090001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2022-09-01

Charakterystyka produktu

_LOLO_
_ _
_(ethinyl estradiol / norethindrone acetate and ethinyl estradiol) _
_Page 1 of 53 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LOLO®
ethinyl estradiol tablets / norethindrone acetate and ethinyl
estradiol tablets
Tablets, 10 mcg ethinyl estradiol / 1 mg norethindrone acetate and 10
mcg ethinyl estradiol, oral
Mfr. Std.
Oral Contraceptive ATC Code: G03AB04
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Date of Initial Authorization:
DEC 12, 2013
Date of Revision:
SEP 14, 2022
Submission Control Number: 263050
_LOLO (ethinyl estradiol / norethindrone acetate and ethinyl
estradiol) _
_Page 2 of 53 _
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
..........................................................................................