VOLTAREN EMULGEL

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

DICLOFENAC DIETHYLAMINE

可用日期:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC代码:

M02AA15

INN（国际名称）:

DICLOFENAC

剂量:

1.16%

药物剂型:

GEL

组成:

DICLOFENAC DIETHYLAMINE 1.16%

给药途径:

TOPICAL

每包单位数:

20/50/75/100/150G 75/100ML

处方类型:

OTC

治疗领域:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

產品總結:

Active ingredient group (AIG) number: 0152187001; AHFS:

授权状态:

APPROVED

授权日期:

2008-04-09

产品特点

_VOLTAREN EMULGEL Back & Muscle Pain / Joint Pain Regular Strength _
_ _
_Diclofenac diethylamine gel 11.6 mg/g (1.16% w/w) Mfr. Std. _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
VOLTAREN EMULGEL
Diclofenac Diethylamine Gel, 11.6 mg/g (1.16% w/w)
Mfr. Std.
VOLTAREN EMULGEL BACK & MUSCLE PAIN
Diclofenac Diethylamine Gel, 11.6 mg/g (1.16% w/w)
Mfr. Std.
VOLTAREN EMULGEL JOINT PAIN REGULAR STRENGTH
Diclofenac Diethylamine Gel, 11.6 mg/g (1.16% w/w)
Mfr. Std.
ATC Code: M02A A15 Anti-inflammatory preparations, non-steroids for
topical use
Separate Product Monograph available for VOLTAREN EMULGEL Extra
Strength and
VOLTAREN EMULGEL Joint Pain Extra Strength (Diclofenac diethylamine
gel, 23.2 mg/g (2.32%
w/w) Mfr. Std.)
GlaxoSmithKline Consumer Healthcare ULC
7333 Mississauga Rd.
Mississauga, Ontario
Canada
L5N 6L4
Date of Initial Authorization:
April 9, 2008
Date of Revision: December
6, 2021
Submission Control Number: 252844
_ _
_VOLTAREN EMULGEL Back & Muscle Pain / Joint Pain Regular Strength _
_ _
_Diclofenac diethylamine gel 11.6 mg/g (1.16% w/w) Mfr. Std. _
_Page 2 of 49_
RECENT MAJOR LABEL CHANGES
2 Contraindications
03/2020
7 Warning and Precautions, 7.1.2 Breast feeding
03/2020
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
...................................................................