MIFEGYMISO KIT

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

MIFEPRISTONE; MISOPROSTOL

Pieejams no:

LINEPHARMA INTERNATIONAL LIMITED

ATĶ kods:

G03XB51

SNN (starptautisko nepatentēto nosaukumu):

MIFEPRISTONE, COMBINATIONS

Deva:

200MG; 200MCG

Zāļu forma:

KIT

Kompozīcija:

MIFEPRISTONE 200MG; MISOPROSTOL 200MCG

Ievadīšanas:

BUCCAL

Vienības iepakojumā:

1 MIFEPRISTONE AND 4 MISOPROSTOL PER PACK

Receptes veids:

Prescription

Ārstniecības joma:

OXYTOCICS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2015-07-29

Produkta apraksts

_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
.....................