MINORGA Cutaneous solution Ref.[51130] Active ingredients: Minoxidil

Source: Medicines Authority (MT)  Revision Year: 2023  Publisher: Laboratoires Bailleul S.A., 10-12 Avenue Pasteur, L-2310 Luxembourg – Luxembourg

Product name and form

Minorga 2%, cutaneous solution.

Pharmaceutical Form

Cutaneous solution.

Clear and colorless or slightly yellow solution with an alcohol odor.

Qualitative and quantitative composition

Minoxidil 20 mg/ml (2% w/v).

One spray of Minorga 2% cutaneous solution contains 2.8 mg of minoxidil. Seven sprays are required to apply approximately 1 ml of solution containing 20 mg of minoxidil.

Excipient with known effect: propylene glycol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Minoxidil

Topical administration of minoxidil stimulates hair growth in men and women with androgenic alopecia. The mechanism of stimulating hair growth from minoxidil is not fully understood, but some actions of minoxidil include increasing hair diameter, stimulating new growth and prolonging the developmental phase, and stimulating hair follicle transition from resting phase (telogen) in the growth phase (regenerative).

List of Excipients

Propylene glycol
Ethanol 96%
Purified water

Pack sizes and marketing

HDPE Bottle with spray pump/applicators containing 60 ml of solution.

Pack sizes:

1 × 60 ml with 1 removable actuator with nozzle and 1 removable actuator with rod.
3 × 60 ml with 3 removable actuators with nozzle and 2 removable actuators with rod.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoires Bailleul S.A., 10-12 Avenue Pasteur, L-2310 Luxembourg – Luxembourg

Marketing authorization dates and numbers

MA1106/00201

Date of first authorisation: 30th September, 2014
Date of latest renewal: 20th August, 2019

Drugs

Drug Countries
MINORGA Malta, Poland, Romania

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.