MIFEGYMISO KIT

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

MIFEPRISTONE; MISOPROSTOL

Доступно од:

LINEPHARMA INTERNATIONAL LIMITED

АТЦ код:

G03XB51

INN (Међународно име):

MIFEPRISTONE, COMBINATIONS

Дозирање:

200MG; 200MCG

Фармацеутски облик:

KIT

Састав:

MIFEPRISTONE 200MG; MISOPROSTOL 200MCG

Пут администрације:

BUCCAL

Јединице у пакету:

1 MIFEPRISTONE AND 4 MISOPROSTOL PER PACK

Тип рецептора:

Prescription

Терапеутска област:

OXYTOCICS

Резиме производа:

Active ingredient group (AIG) number: 0257170001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2015-07-29

Карактеристике производа

_Mifegymiso (mifepristone tablets and misoprostol tablets kit) _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MIFEGYMISO
Mifepristone tablet
Tablet, mifepristone 200 mg, oral administration
Progesterone receptor modulator
and
Misoprostol tablets
Tablets (4), misoprostol 200 mcg (each),
buccal administration
Prostaglandin
Medical Termination of Pregnancy
Sponsor:
LINEPHARMA INTERNATIONAL LIMITED
16, Upper Woburn Place,
London, WC1H 0BS
United Kingdom
Date of Initial Authorization:
JUL. 29, 2015
Date of Revision:
MAY. 02, 2023
Importer and distributor in Canada:
LINEPHARMA INTERNATIONAL INC.
402-21 St Clair Ave E
Toronto, Ontario
M4T 1L9
Submission Control No: 270410
_Mifegymiso (mifepristone tablets and misoprostol tablets kit) _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
05/2023
7 WARNINGS AND PRECAUTIONS, Skin
06/2022
7 WARNINGS AND PRECAUTIONS, Skin
12/2022
TABLE OF CONTENTS
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
.....................