UpdatedPublic Assessment Report Scientific discussion Minoxidil Pfleger 20/50 mg/ml cutaneous spray, solution Minoxidil - AT/H/0451/001-002/DC
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UpdatedPublic Assessment Report
Scientific discussion
Minoxidil Pfleger 20/50 mg/ml cutaneous spray, solution
Minoxidil
AT/H/0451/001-002/DC
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1/7This module reflects the scientific discussion for the approval of Minoxidil Pfleger 20/50 mg cutaneous spray, solution. The procedure was
finalised on 04.03.2013. For information on changes after this date please refer to the module ‘Update’.
I. INTRODUCTION
This decentralised marketing authorisation concerns a hybrid version of Minoxidil, Minoxidil Pfleger 20mg/ml cutaneous spray, solution and Minoxidil
Pfleger 50mg/ml cutaneous spray, solution.
Minoxidil is a vasodilator which when used systemically causes a distinct drop in blood pressure. Topical application of minoxidil leads to stimulation
of hair growth in patients with androgenetic alopecia. Obvious hair growth can be expected at the earliest after 4 months, excessive hair loss can be
stopped after a few weeks following regular application.
A cosmetically satisfying regrowth of terminal hairs has been observed in up to 40 % of patients treated with Minoxidil 20mg/ml following a year of
treatment. With Minoxidil 50mg/ml the success rate was increased to approximately 50 %.
The onset of action and the degree of thickening of the scalp hair varies between patients. Advanced, pre-existing androgenetic alopecia which has been
present for more than 10 years is less responsive to minoxidil. This is probably connected to the absence of hair roots, whose presence is necessary for
the effect.
Growth of new hairs ceases when treatment is discontinued, and within 3 – 4 months, the situation is the same as before beginning treatment.
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2/7The mechanism by which it promotes hair growth is not fully understood. Minoxidil is a potassium channel opener, causing hyperpolarization of cell
membranes and it is also a vasodilator.
Minoxidil is assumed to stimulate the growth of keratinocytes.
II. QUALITY ASPECTS
II.1 Introduction
Minoxidil Pfleger 20/50 mg cutaneous spray, solution is a cutaneous spray, solution which is presented in a polyethylene bottle.
II.2 Drug Substance
The active substance in Minoxidil Pfleger 20/50 mg cutaneous spray, solution is minoxidil. The specification of the active substance meets the current
scientific requirements. The adequate quality of the active substance has been shown by submitting the appropriate control data. The stability of the
active substance has been tested under ICH conditions. The results of the stability studies support the established retest-period.
II.3 Medicinal Product
Minoxidil Pfleger 20/50 mg cutaneous spray, solution contains the following excipients:
Ethanol 96 % (v/v), propylene glycol and purified water.
The manufacturer responsible for batch release is Laboratoires Chemineau, Fance.
The development of the product has been sufficiently made and deemed appropriate. The usage of all the excipients has been described.
The release specification includes the check of all parameters relevant to this pharmaceutical form. Appropriate data concerning the control of the
finished product support the compliance with the release specifications.
The packaging of the medicinal product complies with the current legal requirements.
Stability studies under ICH conditions have been performed and data presented support the shelf life claimed in the SmPC, with a shelf life of 36
months when stored below 25°C.
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3/7The pharmaceutical quality of Minoxidil Pfleger 20/50 mg cutaneous spray, solution has been adequately shown.
II.4 Discussion on chemical, pharmaceutical and biological aspects
Information on development, manufacture and control of active substance and medicinal product has been presented in a satisfactory manner. The
results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics.
III. NON-CLINICAL ASPECTS
Pharmacokinetic and toxicological properties of Minoxidil are well known. Pharmacodynamic properties concerning topical administration are not fully
understood.
The reference medical product is Alostil 2/5% cutaneous solution (Pharmacia SAS, France now Mc Neil). Alostil 2% received approval in December
1986 in France, Alostil 5% received approval in November 1955 in France.
As Minoxidil is a widely used and long-standing, well-known active substance, the applicant has not provided additional studies and further studies do
not seem to be required.
IV. CLINICAL ASPECTS
Pharmacokinetic properties of Minoxidil are well known. Pharmacodynamic properties concerning topical administration are not fully understood. The
reference medical product is Alostil 2/5% cutaneous solution (Pharmacia SAS, France now Mc Neil). Alostil 2% received approval in December 1986
in France, Alostil 5% received approval in November 1955 in France.
As Minoxidil is a widely used and long-standing, well-known active substance, the applicant has not provided additional studies and further studies do
not seem to be required.
The aim of the pharmaceutical development was to design a preparation with an identical qualitative and quantitative composition than the reference
product and showing the same physico-chemical characteristics.
B undesamt f ür Sicherheit im G esundheitswesen
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4/7V. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION
Based on the review of the data on safety and efficacy, the risk-benefit ratio for this application is considered positive and marketing authorisation can
be recommended.
The pharmaceutical quality of Minoxidil Pfleger 20/50 mg cutaneous spray, solution has been adequately shown.
User consultation
1) The package leaflet has been evaluated via a user consultation study in accordance with the requirements of Articles 59(3) and 61(1) of Directive
2001/83/EC. The language used for the purpose of user testing the PIL was French.
The results show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of
medicinal products for human use.
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5/7This module reflects the procedural steps and scientific information after the finalisation of the initial procedure.
Procedure Scope Product Information Date of end of Approval/ Summary/
number* affected procedure non Justification for
approval refuse
AT/H/0451/001- The changes concern the information given with y 15.02.2018 Approval ---
002/II/009 regard to the treatment of patients over 65 years of
age.
These changes are based on the results of the
MAH’s research into the literature and based on
the information given in the reference medicinal
products product information.
*Only procedure qualifier, chronological number and grouping qualifier (when applicable)
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Traisengasse 5, A-1200 Wien, www.basg.at, www.ages.at
DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW
6/7B undesamt f ür Sicherheit im G esundheitswesen
Traisengasse 5, A-1200 Wien, www.basg.at, www.ages.at
DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW
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