TEVA-TIAPROFENIC ACID TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TIAPROFENIC ACID

Disponibil de la:

TEVA CANADA LIMITED

Codul ATC:

M01AE11

INN (nume internaţional):

TIAPROFENIC ACID

Dozare:

200MG

Forma farmaceutică:

TABLET

Compoziție:

TIAPROFENIC ACID 200MG

Calea de administrare:

ORAL

Unități în pachet:

100/500/1000

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0115902001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2011-05-06

Caracteristicilor produsului

_TEVA-TIAPROFENIC ACID (Tiaprofenic acid) _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA–TIAPROFENIC ACID
Tiaprofenic Acid Tablets
Tablets, 200 mg and 300 mg, for oral use
Teva Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
December 31, 1996
Toronto, ON
M1B 2K9
Date of Revision:
Canada
August 15, 2022
www.tevacanada.com
Submission Control No.: 261587
_TEVA-TIAPROFENIC ACID (Tiaprofenic acid) _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
08/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests,
_Pregnancy_
08/2022
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions_
08/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
08/2022
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
..........................................................................