TEVA-NABUMETONE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

NABUMETONE

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

M01AX01

INN (Nama Internasional):

NABUMETONE

Dosis:

500MG

Bentuk farmasi:

TABLET

Komposisi:

NABUMETONE 500MG

Rute administrasi :

ORAL

Unit dalam paket:

60/100/500/1000

Jenis Resep:

Prescription

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0122821001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-04-30

Karakteristik produk

PRODUCT MONOGRAPH
PR
TEVA-NABUMETONE
nabumetone
500 mg and 750 mg Film Coated Tablets
BP Standard
Nonsteroidal Anti-Inflammatory Agent
Teva Canada Limited
DATE OF PREPARATION:
30 Novopharm Court
July 8, 2015
Toronto, Ontario
M1B 2K9
www.tevacanada.com
SUBMISSION CONTROL NO: 185040
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
...............................................................................................
9
DRUG INTERACTIONS
.............................................................................................
12
DOSAGE AND ADMINISTRATION
.........................................................................
13
OVERDOSAGE
...........................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 13
STORAGE AND STABILITY
.....................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 15
PART II: SCIENTIFIC INFORMATION
................................................................... 17
PHARMACEUTICAL INFORMATION
.....................................................................
17
CLINICAL TRIALS
.....................................................................................................
18
DETAILED PHARMACOLOGY
................................................................................
18
TOXICOLOGY
.....................................................