MEN'S ROGAINE FOAM 5% AEROSOL, FOAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MINOXIDIL

Available from:

JOHNSON & JOHNSON INC

ATC code:

D11AX01

INN (International Name):

MINOXIDIL, TOPICAL

Dosage:

5%

Pharmaceutical form:

AEROSOL, FOAM

Composition:

MINOXIDIL 5%

Administration route:

TOPICAL

Units in package:

60G

Prescription type:

OTC

Therapeutic area:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Product summary:

Active ingredient group (AIG) number: 0114429004; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-05-01

Summary of Product characteristics

_Product Monograph Master Template _
_ _
_Men’s ROGAINE® Minoxidil Topical Solution _
_Men’s ROGAINE® Foam 5% Minoxidil Foam _
_Women’s ROGAINE® Foam 5% Minoxidil Foam _
_ _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MEN’S ROGAINE®
Minoxidil Topical Solution
20 mg/mL (2% w/v)
Men’s ROGAINE® FOAM 5%
Minoxidil Foam 50 mg/g (5% w/w)
Women’s ROGAINE® FOAM 5%
Minoxidil Foam 50 mg/g (5%w/w)
Hair Regrowth Treatment
Johnson & Johnson Inc.
88 McNabb Street
Markham, ON
L3R 5L2
Date of Initial Authorization:
OCT 17, 2003
Date of Revision:
JAN 20, 2022
Submission Control Number: 251296
_Product Monograph Master Template _
_ _
_Men’s ROGAINE® Minoxidil Topical Solution _
_Men’s ROGAINE® Foam 5% Minoxidil Foam _
_Women’s ROGAINE® Foam 5% Minoxidil Foam _
_ _
_Page 2 of 66_
TABLE OF CONTENTS
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration.....................................................................................................6
4.5
Misse