VOLTAREN EMULGEL EXTRA STRENGTH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DICLOFENAC DIETHYLAMINE

Available from:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

ATC code:

M02AA15

INN (International Name):

DICLOFENAC

Dosage:

2.32%

Pharmaceutical form:

GEL

Composition:

DICLOFENAC DIETHYLAMINE 2.32%

Administration route:

TOPICAL

Units in package:

30/50/60/100G

Prescription type:

OTC

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0152187002; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-01-18

Summary of Product characteristics

_VOLTAREN EM ULGEL Extra Strength / Joint Pain Extra Strength _
_ _
_Diclofenac diethylamine gel 23.2 mg/g (2.32% w/w) Mfr. Std. _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
VOLTAREN EMULGEL EXTRA STRENGTH
Diclofenac Diethylamine Gel, 23.2 mg/g (2.32% w/w)
Mfr. Std.
VOLTAREN EMULGEL JOINT PAIN EXTRA STRENGTH
Diclofenac Diethylamine Gel, 23.2 mg/g (2.32% w/w)
Mfr. Std.
ATC Code: M02A A15 Anti-inflammatory preparations, non-steroids for
topical use
Separate Product Monograph available for VOLTAREN EMULGEL, VOLTAREN
EMULGEL Back &
Muscle Pain and VOLTAREN EMULGEL Joint Pain Regular Strength
(Diclofenac diethylamine
gel, 11.6 mg/g (1.16% w/w) Mfr. Std.)
GlaxoSmithKline Consumer Healthcare ULC
7333 Mississauga Rd.
Mississauga, Ontario
Canada
L5N 6L4
Date of Initial Authorization:
Aug 21, 2014
Date of Revision: January 10,
2022
Submission Control Number: 255275
_ _
_VOLTAREN EM ULGEL Extra Strength / Joint Pain Extra Strength _
_ _
_Diclofenac diethylamine gel 23.2 mg/g (2.32% w/w) Mfr. Std. _
_Page 2 of 45_
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.............................................................................................................4
2
CONTRAINDICATIONS
...........