VOLTAREN EMULGEL

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DICLOFENAC DIETHYLAMINE

Διαθέσιμο από:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Φαρμακολογική κατηγορία (ATC):

M02AA15

INN (Διεθνής Όνομα):

DICLOFENAC

Δοσολογία:

1.16%

Φαρμακοτεχνική μορφή:

GEL

Σύνθεση:

DICLOFENAC DIETHYLAMINE 1.16%

Οδός χορήγησης:

TOPICAL

Μονάδες σε πακέτο:

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

Τρόπος διάθεσης:

OTC

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2008-04-09

Αρχείο Π.Χ.Π.

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