Mirvaso

Основна информация

  • Търговско наименование:
  • Mirvaso
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Mirvaso
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Other dermatological preparations
  • Терапевтична област:
  • Skin Diseases
  • Терапевтични показания:
  • Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.,
  • Каталог на резюме:
  • Revision: 10

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002642
  • Дата Оторизация:
  • 20-02-2014
  • EMEA код:
  • EMEA/H/C/002642
  • Последна актуализация:
  • 11-05-2020

Доклад обществена оценка

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An agency of the European Union

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www.ema.europa.eu

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

EMA/401/2014

EMEA/H/C/002642

EPAR summary for the public

Mirvaso

brimonidine

This is a summary of the European public assessment report (EPAR) for Mirvaso. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Mirvaso.

For practical information about using Mirvaso, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Mirvaso and what is it used for?

Mirvaso is a medicine that contains the active substance brimonidine tartrate. It is used to treat the

facial erythema (redness of the skin of the face) in adults with rosacea, a long-term skin condition that

often causes flushing and redness.

How is Mirvaso used?

Mirvaso is available as a gel (3 mg/g) and can only be obtained with a prescription. Mirvaso should

only be applied to the skin of the face. Small amounts of gel (about pea size) are applied to the skin of

the forehead, chin, nose and cheeks once a day as a thin layer. The areas should be left to dry out

before applying other creams or cosmetics. For further information, see the package leaflet.

How does Mirvaso work?

Rosacea is a skin condition affecting mainly the face. Symptoms include episodes of redness that have

been linked to the widening of small blood vessels in the skin of the face, which increases the blood

flow to the area.

The active substance in Mirvaso, brimonidine tartrate, works by attaching to receptors called alpha

adrenergic receptors on the cells of blood vessels of the skin and activating them. This causes these

blood vessels to narrow, which reduces the blood flow to the face, thus decreasing the redness.

Mirvaso

EMA/401/2014

Page 2/3

What benefits of Mirvaso have been shown in studies?

Mirvaso has been evaluated in two main studies involving a total of 553 patients with moderate or

severe facial redness caused by rosacea. Both studies compared Mirvaso with placebo (a dummy gel)

over four weeks of treatment. The main measure of effectiveness was the percentage of patients who

achieved a marked reduction of facial redness at different time points (3, 6, 9 and 12 hours) on days

1, 15 and 29 after the start of the treatment.

Both studies showed that Mirvaso applied once a day was more effective than placebo at reducing the

facial redness in these patients.

In the first study, on day 1 the percentage or patients who had reduction of facial redness 3 hours

after application was 16.3% (21 out of 129) for Mirvaso compared with 3.1% (4 out of 131) for

placebo. Effects were maintained for 12 hours after application although the effects started to wear

off after 6 hours. On day 29, 31.5% (40 out of 127) patients had reduction of facial redness 3

hours after application with Mirvaso compared with a response of 10.9% (14 out of 128) for

placebo.

In the second study, on day 1 the percentage or patients who had reduction of facial redness 3

hours after application was 19.6% (29 out of 148 patients) for Mirvaso compared with 0 % (none

out of 145 patients) for placebo. Effects were also maintained for 12 hours after application and

started to wear off after 6 hours. On day 29, 25.4% (36 out of 142) of patients had reduction of

facial redness 3 hours after application with Mirvaso compared with a response of 9.2 % (13 out of

142) for placebo.

What are the risks associated with Mirvaso?

The most common side effects with Mirvaso (which may affect more than 1 in 100 people), which are

usually mild to moderate in severity, are erythema (redness), pruritus (itching), flushing and a burning

sensation of the skin. For the full list of side effects reported with Mirvaso, see the package leaflet.

Mirvaso must not be used in children below 2 years of age or in patients receiving other medicines

such as monoamine oxidase (MAO) inhibitors or certain antidepressants. Mirvaso should not be used in

children or adolescents aged from 2 to 18 years. For the full list of restrictions, see the package leaflet.

Why is Mirvaso approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Mirvaso’s benefits

are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded

that Mirvaso improves the facial redness in patients with rosacea. Regarding safety, the CHMP

acknowledged that the safety profile is acceptable since most of the adverse events reported occur

locally (on the skin) and are similar to those commonly observed with other rosacea medicines applied

to the skin.

What measures are being taken to ensure the safe and effective use of

Mirvaso?

A risk management plan has been developed to ensure that Mirvaso is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

Mirvaso

EMA/401/2014

Page 3/3

the package leaflet for Mirvaso, including the appropriate precautions to be followed by healthcare

professionals and patients.

Further information can be found in the summary of the risk management plan

Other information about Mirvaso

The European Commission granted a marketing authorisation valid throughout the European Union for

Mirvaso on 21 February 2014.

The full EPAR and risk management plan summary for Mirvaso can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more

information about treatment with Mirvaso, read the package leaflet (also part of the EPAR) or contact

your doctor or pharmacist.

This summary was last updated in 02-2014.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Mirvaso 3 mg/g gel

brimonidine

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor. This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet

What Mirvaso is and what it is used for

What you need to know before you use Mirvaso

How to use Mirvaso

Possible side effects

How to store Mirvaso

Contents of the pack and other information

1.

What Mirvaso is and what it is used for

Mirvaso contains the active substance brimonidine which belongs to a group of medicines commonly

referred to as “alpha agonists”.

It is applied to the skin of the face to treat redness due to rosacea in adult patients.

Redness of the face due to rosacea is caused by high levels of blood flow in the facial skin, which is

the result of enlargement (dilation) of the small blood vessels of the skin.

When applied, Mirvaso acts to narrow these blood vessels again which reduces the excess blood flow

and redness.

2.

What you need to know before you use Mirvaso

Do not use Mirvaso:

if you are allergic to brimonidine or any of the other ingredients of this medicine (listed in

section 6).

in children below 2 years of age, as they may be at greater risk of side effects from any of the

medicine absorbed through the skin.

if you are taking certain medicines used for depression or Parkinson’s disease including

so-called monoamine oxidase (MAO) inhibitors (for example selegiline or moclobemide)

or tricyclic antidepressants (such as imipramine) or tetracyclic antidepressants (such as

maprotiline, mianserin or mirtazapin). Use of Mirvaso when taking these medicines may result

in a fall in blood pressure.

Warnings and precautions

Talk to your doctor or pharmacist, before using Mirvaso especially if:

the skin of your face is irritated or has open wounds.

you have problems with your heart or your blood circulation.

you have depression, decreased blood flow to the brain or the heart, fall in blood pressure on

standing up, decreased blood flow to the hands, feet or skin, or Sjögren’s syndrome (a chronic

disease in which the body’s natural defence - the immune system - attacks the

moisture-producing glands).

you have kidney or liver problems or have had them in the past.

you have had, or plan to have any laser procedure on the skin of your face.

It is important to start treatment with a small amount of gel, increase the dose gradually but do not

exceed the maximum dose of 1 gram (approximately 5 pea sized amounts). See also instructions ‘How

to use Mirvaso’.

Do not apply Mirvaso more than once a day and do not exceed the maximum daily dose of 1gram

(approximately 5 pea sized amounts). See also instructions ‘How to use Mirvaso’.

Worsening of skin redness, flushing or burning feeling of the skin

Up to 1 in 6 patients experience the return of their redness worse than it was initially. Such worsening

of redness usually develops within the first 2 weeks of treatment with Mirvaso. Generally, it resolves

spontaneously after treatment is stopped. The effect should gradually disappear within a few days in

most cases. Before you restart the treatment with Mirvaso, test it on a small area of the face on a day

when you can stay at home. If you do not experience worsening of redness or burning, continue with

the usual treatment (see section 3).

In case of worsening or unexpected redness, discontinue the treatment and contact your doctor.

If any of the above applies to you, talk to your doctor since this medicine may not be suitable for you.

Children and adolescents

Do not give this medicine to children and adolescents

under the age of 18 years because the

safety and

efficacy has not been established for this age group. This is particularly important in children under

the age of 2 years (see ‘Do not use Mirvaso’).

Other medicines and Mirvaso

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines, because these medicines could affect your treatment with Mirvaso or Mirvaso could affect

your treatment with these medicines.

Do not take Mirvaso with selegiline, moclobemide, imipramine, mianserin, or maprotiline, which are

medicines that can be used for depression or Parkinson’s disease, as this could lead to a change in the

effectiveness of Mirvaso or could increase the chances for side effects such as a fall in blood pressure

(see under ‘Do not use Mirvaso’).

Also, tell your doctor if you are taking any of the following medicines:

medicines used for the treatment of pain, sleep disorders, or anxiety disorders

medicines used for the treatment of psychiatric disorders (chlorpromazine) or used for

hyperactivity (methylphenidate) or used for high blood pressure (reserpine).

medicines which act on the same body mechanism as Mirvaso (other alpha agonists, e.g.

clonidine; so-called alpha blockers or alpha antagonists, e.g. prazosin, isoprenaline which are

most often used for treatment of high blood pressure, slow heart rate or asthma).

cardiac glycosides (e.g. digoxin), used to treat heart problems.

blood pressure lowering medicine such as beta-blockers or calcium channel blockers (e.g.

propranolol, amlodipine).

If any of the above applies to you, or if you are unsure, talk to your doctor.

Mirvaso with alcohol

Tell your doctor if you consume alcohol regularly as this could affect your treatment with this

medicine.

Pregnancy and breast-feeding

The use of Mirvaso is not recommended during pregnancy. This is because its effects on your unborn

baby are unknown. You should not use this medicine during breast-feeding, as it is unknown whether

this medicine passes into the breast milk.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before using this medicine.

Driving and using machines

Mirvaso has no significant influence on the ability to drive and use machines.

Mirvaso contains:

Methylparahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).

Propylene glycol (E1520) which may cause skin irritation.

3.

How to use Mirvaso

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

Important: Mirvaso is intended for adults and only for use on the skin of the face. Do not use this

medicine on other parts of your body, especially moist body surfaces, e.g. your eyes, mouth, nose or

vagina.

Do not swallow.

Keep Mirvaso gel away from children.

How to use Mirvaso

Mirvaso is recommended to be applied to the face once a day only.

During the first week, start the treatment with a small amount of gel (a pea-sized amount) as explained

by your doctor or nurse.

If your symptoms remain the same or improve only slightly, you may then gradually increase the

amount of gel. Spread it smoothly and evenly as a very thin layer as directed by your doctor or nurse.

It is important not to exceed the maximum daily dose of 1gram (5 pea sized amounts applied to the

whole face).

You should wash your hands immediately after applying this medicine.

If your symptoms worsen during treatment with Mirvaso (increased redness, or burning), stop

treatment and make an appointment to see your doctor – see also section 2 under `Warnings and

precautions’.

You must avoid the eyes, eyelids, lips, mouth, and the inside of the nose. Should any gel get onto these

areas, wash them immediately with plenty of water. If you experience worsening of redness or burning

you should stop using Mirvaso and contact your doctor if needed.

Do not apply any other skin medicines or cosmetics immediately before the daily application of

Mirvaso. You should use these products only after the applied Mirvaso has dried.

Pay attention when opening the tube / pump for the first time, not to spill a larger quantity of gel than

what is needed. If this occurs, you should discard the excess gel so as not to apply more than the

recommended dose. See paragraph “How to use Mirvaso” above.

[EU/1/13/904/004-006]

How to open the tube with a child-resistant cap

To avoid spilling, do not squeeze the tube while opening or closing.

Push down on the cap and turn counterclockwise (turn to the left). Then pull the cap off.

How to close the tube with a child-resistant cap

Push down and turn clockwise (turn to the right).

[EU/1/13/904/007]

How to open the pump with a child-resistant cap

Push down on the cap and turn counterclockwise (turn to the left) until the cap can be removed.

Note: when the cap is removed, the pump is not child-resistant.

Before the first use, prime the pump by pressing down several times until the medicine is idispensed

onto your fingertip.

To apply Mirvaso gel to your face, dispense a pea-sized amount of Mirvaso from the pump onto your

fingertip. Continue to press down the pump to get the number of pea sizes you need according to your

doctor’s prescription (but no more than 5 pea sizes in total).

To close the pump, place the cap back on the pump. Push down and turn the cap to the right

(clockwise) until it stops. The pump is child-resistant again.

If you use more Mirvaso than you should

If you use more than the maximum daily dose of 1 gram within a 24 hour period, it could lead to skin

irritation or other side effects at the application site. Repeated doses within the same 24 hour period

could result in side effects, such as low blood pressure, drowsiness or sleepiness.

Please contact your doctor, who will advise you on what action to take.

If anyone, especially a child, accidentally swallows Mirvaso, they may have serious side effects

and need to be treated in a hospital.

Contact your doctor immediately or go to a hospital emergency department right away if you, a child,

or anyone else swallows this medicine and has any of these symptoms: feeling dizzy from low blood

pressure, vomiting, tiredness or drowsiness, decreased or irregular heartbeats, small pupils (constricted

pupils), difficult or slow breathing, floppiness, low body temperature and convulsions (fits). Take the

medicine pack with you, so the doctor knows what was swallowed.

If you forget to use Mirvaso

Mirvaso works on a daily basis, starting with the first day of treatment. If you miss a daily dose, your

redness will not be reduced for that day. Do not use a double dose to make up for a forgotten dose and

continue your treatment as prescribed.

If you stop using Mirvaso

A potential consequence of stopping the treatment before finishing the course of treatment is the

disease to come back to its initial state. Please contact your doctor before stopping your treatment, so

that he could advice a replacement treatment as appropriate.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you develop uncommon side effects of severe skin irritation or inflammation, skin rash, skin pain or

discomfort, dry skin, warm skin sensation, tingling or sensation of pins and needles or swelling of the

face or common side effects like worsening of rosacea, discontinue the treatment and talk to your

doctor since this medicine may not be suitable for you. In some cases, symptoms may extend beyond

the treatment area. See also section 2 under ‘Warnings and precautions’.

If you develop contact allergy (e.g. allergic reaction, rash) or rare angioedema (a serious allergic

reaction see rarely usually with swelling of the face, mouth or tongue), stop using Mirvaso and seek

prompt medical advice.

Mirvaso may also cause the following other side effects:

Common side effects (may affect up to 1 in 10 people):

flushing

excessive whitening (pallor) where the gel is applied

skin redness, burning feeling of the skin or itching

Uncommon side effects (may affect up to 1 in 100 people):

acne

dry mouth

feeling cold in hands and feet

feeling hot

headache

nasal congestion

swelling of the eyelid

urticaria

dizziness

Rare side effects (may affect up to 1 in 1000 people):

hypotension (blood pressure decreased)

heart rate decrease (slow heart rate, known as bradycardia).

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.

How to store Mirvaso

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, tube and pump after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage condition.

Do not freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how

to throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Mirvaso contains

The active substance is brimonidine. One gram of gel contains 3.3 mg of brimonidine,

equivalent to 5 mg of brimonidine tartrate.

The other ingredients are carbomer, methylparahydroxybenzoate (E218), phenoxyethanol,

glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water. See

end of section 2 for information on methylparahydroxybenzoate and propylene glycol.

What Mirvaso looks like and contents of the pack

Mirvaso is a white to light yellow, opaque gel. It is supplied in tubes containing 2, 10 or 30 grams of gel

or in airless pump system containing 30 g of gel.

Pack size of 1 tube or 1 pump.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Galderma International

Tour Europlaza, 20 avenue André Prothin – La Défense 4

La Défense Cedex 92927

France

Manufacturer

Laboratoires Galderma

Z.I. Montdésir

74540 Alby-sur-Chéran

France

Galderma Laboratorium GmbH

Toulouser Allee 19a-23a

D-40211 Düsseldorf

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

Österreich

Galderma Austria GmbH

Tel: 0043 732 715 993

e-mail: austria@galderma.com

Italia

Galderma Italia S.p.A.

Tel: + 39 039 63 4691

België/Belgique/Belgien

Luxembourg/Luxemburg

Galderma Benelux BV

Tél/Tel: +31 183691919

e-mail:

info.be@galderma.com

Latvija

H. Abbe Pharma GmbH

Tel: +371/67/103205

e-mail: birojs@habbe.lv

България

Елана Фарм ООД

София, ул.“Плачковица“9, ет.3

Тел.: + 359 2 962 15 26

e-mail: office@elanapharm.com

Lietuva

H. Abbe Pharma GmbH atstovybė

Tel: +370/52/711710

e-mail: info@abbepharma.lt

Česká republika

Slovenská republika

Galenoderm s.r.o.

Tel: +421 2 49 10 90 10

e-mail: info@galenoderm.com

Magyarország

Ewopharma Hungary Kft.

Tel.: +36 1 200 4650

e-mail: info@ewopharma.hu

Danmark

Norge

Ísland

Suomi/Finland

Sverige

Galderma Nordic AB

Tlf/Sími/Puh/Tel: + 46 18 444 0330

e-mail: nordic@galderma.com

Malta

Prohealth Limited

Tel. +356 21461851, +356 21460164

e-mail:info@prohealth.com.mt

Deutschland

Galderma Laboratorium GmbH

Tel: + 49 (0) 800 – 5888850

e-mail: patientenservice@galderma.com

Nederland

Galderma Benelux BV

Tel: + 31 183691919

e-mail: info.nl@galderma.com

Eesti

H. Abbe Pharma GmbH

Tel: + 372/6/460980

e-mail: info@habbepharma.ee

Polska

Galderma Polska Sp. z o.o.

Tel.: + 48 22 331 21 80

e-mail: info.poland@galderma.com

Ελλάδα

Κύπρος

Pharmassist Ltd

Τηλ: + 30 210 6560700

e-mail: safety@pharmassist.gr

Portugal

Laboratorios Galderma, SA – Sucursal em

Portugal

Tel: + 351 21 315 19 40

e-mail: galderma.portugal@galderma.com

España

Laboratorios Galderma SA

Tel: + 34 902 02 75 95

e-mail: RegulatorySpain@galderma.com

România

Neola pharma SRL

Tel: + 40 21 233 17 81

e-mail: office.neola@neolapharma.ro

France

Ireland

Galderma International

Tél: +33 (0)8 20 20 45 46

e-mail: pharmacovigilance.france@galderma.com

Slovenija

Medical Intertrade d.o.o.

T: +386 1 2529 113

F: +386 1 2529 114

e-mail: info@medical-intertrade.si

Hrvatska

Medical Intertrade d.o.o.

T: +385 1 333 6036

e-mail: registracije@medical-intertrade.hr

United Kingdom

Galderma (UK) Ltd.

Tel: + 44 (0) 1923 208950

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency

web site: http://www.ema.europa.eu.