HAIR REGROWTH TREATMENT SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

MINOXIDIL

Tilgjengelig fra:

APOTEX INC

ATC-kode:

D11AX01

INN (International Name):

MINOXIDIL, TOPICAL

Dosering :

2%

Legemiddelform:

SOLUTION

Sammensetning:

MINOXIDIL 2%

Administreringsrute:

TOPICAL

Enheter i pakken:

60ML

Resept typen:

OTC

Terapeutisk område:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0114429001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2016-12-23

Preparatomtale

Page 1 of 36
PRODUCT MONOGRAPH
HAIR REGROWTH TREATMENT
MINOXIDIL TOPICAL SOLUTION USP
20 MG/ML (2% W/V)
HAIR REGROWTH TREATMENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
April 06, 2020
TORONTO ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 235865
Page 2 of 36
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
..........................................................................................................
5
DRUG
INTERACTIONS...........................................................................................................
8
OVERVIEW
...............................................................................................................................
8
DOSAGE AND ADMINISTRATION
......................................................................................
9
OVERDOSAGE
.......................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 13
DOSAGE FORM, COMPOSITION AND PACKAGING
...................................................... 15
PART II: SCIENTIFIC INFORMATION
..................................................................................
16
PHARMACEUTICAL INFORMATION
................................................................................
16
CLINICAL TRIALS
................................................................................................................