Mirvaso

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Mirvaso 3 mg/g gel 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate. 
 
Excipient(s) with known effect: 
One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene glycol 
(E1520). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Gel. 
 
White to light yellow opaque aqueous gel. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients. 
 
4.2 Posology and method of administration 
 
Posology 
 
One application per 24 hours, at any time suitable for the patient, for as long as facial erythema is 
present. 
 
The maximum daily recommended dose is 1 g of gel in total weight, which corresponds to 
approximately five pea sized amounts. 
 
Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one 
week. The amount of gel can then be increased gradually based on tolerability and patient response.  
 
Special populations 

 

Elderly patients 

The experience of use of Mirvaso in patients aged above 65 years is limited (see also section 4.8). No 
dose adjustment is necessary. 
 
Hepatic and renal impairment 

Mirvaso has not been studied in patients with hepatic and renal impairment. 
 
 
Paediatric population 

 
The safety and efficacy of Mirvaso in children and adolescents aged less than 18 years have not been 
established. No data are available. 
 



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Mirvaso is contraindicated in children aged less than 2 years because of serious systemic safety risk 
(see section 4.3). Safety concerns related to the systemic absorption of brimonidine have also been 
identified for the age group 2 to 12 years (see section 4.9). Mirvaso should not be used in children or 
adolescents aged 2 to 18 years. 
 
Method of administration 
 
Cutaneous use only. 
 
Mirvaso should be applied smoothly and evenly as a thin layer across the entire face (forehead, chin, 
nose and both cheeks) avoiding the eyes, eyelids, lips, mouth and membrane of the inner nose. 
Mirvaso should be applied only to the face. 
 
Hands should be washed immediately after applying the medicinal product. 
 
Mirvaso can be used in conjunction with other cutaneous medicinal products for the treatment 
of inflammatory lesions of rosacea and with cosmetics. These products should not be applied 
immediately before the daily application of Mirvaso; they may be used only after the applied 
Mirvaso has dried. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Children aged less than 2 years. 
 
Patients receiving monoamine oxidase (MAO) inhibitor therapy (for example selegiline or 
moclobemide) and patients on tricyclic (such as imipramine) or tetracyclic (such as maprotiline, 
mianserin or mirtazapin) antidepressants which affect noradrenergic transmission. 
 
4.4 Special warnings and precautions for use 
 
Mirvaso should not be applied on irritated skin (including following laser therapy) or open wounds.  
In case of severe irritation or contact allergy, the treatment with the medicinal product should be 
discontinued. 
 
Exacerbation of rosacea symptoms is very common in patients treated with Mirvaso. Across all 
clinical studies, 16% of patients receiving Mirvaso experienced an event of symptom exacerbation. 
Treatment should be initiated with a small amount of gel and the dose increased gradually, based on 
tolerability and response to treatment (see section 4.2). 
 
Erythema and flushing 
The effect of Mirvaso topical gel begins to diminish hours after application. In some patients, 
erythema and flushing were reported to return with greater severity than was present at baseline. Most 
of the cases were observed within the first 2 weeks of starting the treatment (see section 4.8). 
 
The onset of flushing relative to application of Mirvaso topical gel varied, ranging from 
approximately 30 minutes to several hours (see section 4.8). 
 
In the majority of these cases, erythema and flushing resolved after discontinuation of 
Mirvaso topical gel. 
 
In case worsening of erythema occurs, Mirvaso topical gel should be discontinued. Symptomatic 
measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms. 
 
Recurrences of aggravated erythema and flushing have been reported after re-administration of 
Mirvaso topical gel. Prior to resuming treatment after temporary discontinuation due to aggravated 



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erythema or flushing, perform a test application on a small area of the face for at least one day before 
full facial application is resumed. 
 
It is important to inform the patient not to exceed the recommended maximum dose (5 pea size 
amounts) and frequency of application (once daily). 
 
Mirvaso should not be applied close to the eyes. 
 
Concomitant use of other systemic alpha adrenergic receptor agonists 
The concomitant use of other systemic alpha adrenergic receptor agonists may potentiate the 
undesirable effects of this class of medicinal products in patients: 
- with severe or unstable or uncontrolled cardiovascular disease; 
- with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic 

hypotension, thrombangiitis obliterans, scleroderma, or Sjögren’s syndrome. 
 
Other 
Any increase in the daily amount applied above 5 pea sized amounts and/or increase in frequency of 
daily application of the medicinal product should be avoided, since the safety of higher daily doses or 
repeated daily application has not been assessed. 
 
The medicinal product contains methylparahydroxybenzoate (E218) which may cause allergic 
reactions (possibly delayed), and propylene glycol (E1520) which may cause skin irritation. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
Mirvaso is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy 
and patients on tricyclic or tetracyclic antidepressants which affect noradrenergic transmission 
(see section 4.3). 
 
The possibility of an additive or potentiating effect with central nervous system depressants 
(alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. 
 
No data on the level of circulating catecholamines after Mirvaso administration are available. Caution, 
however, is advised in patients taking substances which can affect the metabolism and uptake of 
circulating amines e.g. chlorpromazine, methylphenidate, reserpine. 
 
Caution is advised when initiating (or changing the dose of) a concomitant systemic substance 
(irrespective of pharmaceutical form) which may interact with alpha adrenergic receptor agonists or 
interfere with their activity i.e. agonists or antagonists of the adrenergic receptor e.g. (isoprenaline, 
prazosin). 
 
Brimonidine may cause clinically insignificant decreases in blood pressure in some patients. Caution 
is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac 
glycosides concomitantly with brimonidine. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no or limited amount of data from the use of brimonidine in pregnant women. Animal 
studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity 
(see section 5.3). As a precautionary measure, it is preferable to avoid the use of Mirvaso during 
pregnancy. 
 



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Breast-feeding 
It is unknown whether brimonidine/metabolites are excreted in human milk. A risk to the 
newborns/infants cannot be excluded. Mirvaso should not be used during breast-feeding. 
 
Fertility 
Brimonidine did not present any special reproductive or developmental hazard in animal species. 
 

4.7 Effects on ability to drive and use machines 
 
Mirvaso has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most commonly reported adverse reactions are erythema, pruritus, flushing and skin burning 
sensation, all occurring in 1.2 to 3.3% of patients in clinical studies. They are typically mild to 
moderate in severity, and usually do not require discontinuation of treatment. Aggravated erythema, 
flushing and skin burning sensation have been reported during the post-marketing period (see 
section 4.4). 
 
Tabulated list of adverse reactions 
The adverse reactions are classified by System Organ Class and frequency, using the following 
convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), 
rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the 
available data) and were reported with Mirvaso either in clinical studies, or during the post-marketing 
experience (identified by an asterix (*) in Table 1). 
 
Table 1 – Adverse reactions 
 
System Organ Class Frequency Adverse reactions 
Cardiac disorders Rare Bradycardia* 
Nervous system disorders Uncommon Headache, paraesthesia 
Eye disorders Uncommon Eyelid oedema 
Vascular disorders Common Flushing, pallor at the application site* 

Uncommon Dizziness* 
Rare Hypotension* 

Respiratory, thoracic and 
mediastinal disorders 

Uncommon Nasal congestion 

Gastrointestinal disorders Uncommon Dry mouth 
Skin and subcutaneous tissue 
disorders 

Common Erythema, pruritus, rosacea, skin burning 
sensation 

Uncommon Acne, allergic contact dermatitis, contact 
dermatitis, dermatitis, dry skin, pain of skin, skin 
discomfort, rash papular, skin irritation, skin 
warm, swelling face*, urticaria* 

Rare Angioedema* 
General disorders and 
administration site conditions 

Uncommon Feeling hot, peripheral coldness 

* Adverse reactions reported from post-marketing data. 
 
Description of selected adverse reactions 
Bradycardia and hypotension 
Post-marketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness 
have been reported, some of which required hospitalisation. Some cases involved application of 
Mirvaso following laser procedures (see section 4.4). 
 



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Other special populations 
Elderly patients 

No meaningful differences in the safety profiles were observed between the elderly subject population 
and subjects 18 to 65 years of age. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. 
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Overdoses after oral use of other alpha2-agonists have been reported to cause symptoms such as 
hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, 
hypotonia, hypothermia, respiratory depression and seizure. 
 
Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should 
be maintained. 
 
Paediatric population 
Serious adverse reactions following inadvertent ingestion of Mirvaso by two young children of one 
clinical study subject have been reported. The children experienced symptoms consistent with 
previously reported oral overdoses of alpha2-agonist in young children. Both children were reported 
to have made a full recovery within 24 hours. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other dermatological preparations, Other dermatologicals,  
ATC code: D11AX21. 
 

Mechanism of action 
Brimonidine is a highly selective alpha2-adrenergic receptor agonist that is 1000-fold more selective 
for the alpha2-adrenergic receptor than the alpha1-adrenergic receptor. 
 
Pharmacodynamic effects 
Cutaneous facial application of a highly selective alpha2-adrenergic receptor agonist reduces erythema 
through direct cutaneous vasoconstriction. 
 
Clinical efficacy and safety 
The efficacy of Mirvaso in the treatment of moderate to severe facial erythema of rosacea has been 
demonstrated in two randomised, vehicle controlled blinded clinical trials, which were identical in 
design. Moderate to severe erythema was defined as a grade 3 or greater on both the Clinician 
Erythema Assessment (CEA) scale and Patient Self-Assessment (PSA) scale. The studies were 
conducted in 553 randomised subjects aged 18 years and older who were treated once daily 
for 4 weeks with either Mirvaso or vehicle. Of these, 539 completed 29 days of treatment and had data 
available to be included in the efficacy analysis at Day 29, with the majority being Caucasians 
between 18 and 65 years of age. 
 
The primary endpoint was expressed in terms of composite success i.e. subjects responding with 
a 2-grade reduction on both baseline CEA score and baseline PSA score on Day 29. The results from 
both clinical studies demonstrated that Mirvaso was significantly more effective (p<0.001) in the 
reduction of facial erythema of rosacea than vehicle gel when applied once daily for 29 days (primary 
endpoint, see Table 2). For the population subset of patients with severe erythema at baseline 



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Day 1 (i.e. subjects with CEA or PSA grade of 4) which represented 26% of the randomised subjects, 
the results on the primary endpoint on Day 29 were similar to those results observed in the overall 
population (see Table 3) and were statistically significant for both studies combined (p=0.003). In 
addition, for the overall population, Mirvaso demonstrated statistical superiority (p<0.001) over 
vehicle gel with respect to rapid initial onset of a clinically meaningful effect (1-Grade Composite 
Success for CEA and PSA) after the first application at 30 minutes on Day 1(secondary 
endpoint 27.9% vs. 6.9% for Study 1, 28.4% vs. 4.8% for Study 2), and to achievement of a clinically 
meaningful effect (1-Grade Composite Success for CEA and PSA) on Day 29 (tertiary endpoint, see 
Table 4). 
 
CEA and PSA were defined as follows: 
CEA: Clinician Erythema Assessment: 0=Clear skin with no signs of erythema, 1=Almost clear; slight 
redness, 2=Mild erythema; definite redness, 3=Moderate erythema+ marked redness and 4=Severe 
erythema+ fiery redness 
 
PSA: Patient Self-Assessment: 0=No redness, 1=Very mild redness, 2=Mild redness, 3=Moderate 
redness and 4=Severe redness 
 
Table 2: Percentage of subjects with a 2-grade improvement in both CEA and PSA 
 
Success day 29 Study 1 Study 2 

Mirvaso 
Gel n=127 

Vehicle 
Gel n=128 

Mirvaso 
Gel n=142 

Vehicle 
Gel n=142 

3 hours after application 31.5% 10.9% 25.4% 9.2% 
6 hours after application 30.7% 9.4% 25.4% 9.2% 
9 hours after application 26.0% 10.2% 17.6% 10.6% 
12 hours after application 22.8% 8.6% 21.1% 9.9% 
Day 29 p-value <0.001 - <0.001 -  
 
Table 3: Percentage of subjects with severe erythema at baseline Day 1 (CEA or PSA grade 4) 
with 2-grade improvement in both CEA and PSA 
 
Success day 29 Study 1 + Study 2 

Mirvaso Gel n=79 Vehicle Gel n=63 
3 hours after application 22.8% 9.5% 
6 hours after application 26.6% 7.9% 
9 hours after application 20.3% 11.1% 
12 hours after application 21.5% 4.8% 
Day 29 p-value 0.003 - 
 
Table 4: Percentage of subjects with a 1-grade improvement in both CEA and PSA 
 
Success Day 29 Study 1 Study 2 

Mirvaso 
Gel n=127 

Vehicle 
Gel n=128 

Mirvaso 
Gel n=142 

Vehicle 
Gel n=142 

3 hours after application 70.9% 32.8% 71.1% 40.1% 
6 hours after application 69.3% 32.0% 64.8% 43.0% 
9 hours after application 63.8% 29.7% 66.9% 39.4% 
12 hours after application 56.7% 30.5% 53.5% 40.1% 
Day 29 p-value <0.001 - <0.001 - 
 
No clinically meaningful trends with respect to tachyphylaxis or rebound effects (worsening of 
baseline erythema after cessation of treatment) were observed with use of Mirvaso for 29 days. 
 
The results from a long term open label study in 449 patients, with continuous treatment for up to one 
year, confirmed that chronic use of Mirvaso is safe and effective. Daily reductions in erythema for the 



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first month of use (as measured with the CEA and PSA scales) were similar to those observed in the 
controlled trials, and those reductions were achievable for up to 12 months with no apparent loss 
of effect over time. The overall frequencies of adverse reactions in this study are reflected in 
Table 1 above, with the highest rates occurring in the first 29 days of use. No adverse reactions 
had an increase in frequency over time, and there was no evidence that long-term use of 
Mirvaso conveyed an increased risk of occurrence of any specific type of adverse reaction. 
 
Concomitant use of Mirvaso with other medicinal products for the treatment of inflammatory lesions 
of rosacea has not been systematically investigated. However, in the long term open label study, the 
efficacy and safety of Mirvaso, as described above, was not affected by the concomitant use of 
cosmetics or other medicinal products (e.g. topical metronidazole, topical azelaic acid, and oral 
tetracyclines including low dose doxycycline) for the treatment of inflammatory lesions of rosacea 
in the concerned subpopulation (131/449 patients in the study used concomitant rosacea medicinal 
product). 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Mirvaso in all subsets of the paediatric population in treatment of rosacea (see section 4.2 for 
information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
The absorption of brimonidine from Mirvaso was evaluated in a clinical study in 24 adult subjects 
with facial erythema of rosacea. All enrolled subjects received a single-day ocular administration of 
a 0.2% eye drops solution of brimonidine followed by a once daily cutaneous application of Mirvaso 
for 29 days (intra-individual comparison of systemic exposure). On Day 1 of the study, all subjects 
received 1 drop of the 0.2% eye drops solution in each eye, every 8 hours over a 24-hour period 
(3 doses in total). 
 
After repeated cutaneous application of Mirvaso on facial skin, no drug accumulation in plasma was 
observed throughout the treatment duration: the highest mean (± standard deviation) plasma maximum 
concentration (Cmax) and area under the concentration-time curve from 0 to 24 hours (AUC0-24hr) 
were 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL respectively. These levels are significantly lower 
(2-fold) than those observed following single-day ocular administration of a 0.2% eye drops solution 
of brimonidine. 
 
Distribution 
The protein binding of brimonidine has not been studied. 
 
Biotransformation 
Brimonidine is extensively metabolised by the liver. 
 
Elimination 
Urinary excretion is the major route of elimination of brimonidine and its metabolites. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction 
and development. 
 
 



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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Carbomer 
Methylparahydroxybenzoate (E218) 
Phenoxyethanol 
Glycerol 
Titanium dioxide 
Propylene glycol (E1520) 
Sodium hydroxide 
Purified water 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
2 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage condition. 
Do not freeze. 
 
6.5 Nature and contents of container 
Tube of 2g 
Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a 
high density polyethylene (HDPE) head and polyethylene (PE) child resistant closure 
 
Tube of 10 g and 30g 
Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a 
high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure. 
 
Pump of 30 g 
Multidose container with airless pump system with child resistant closure. 
Polypropylene (PP) / Thermoplastic Polyolefin (TPO) / high density polyethylene (HDPE) and 
polypropylene (PP) child resistant closure. 
 
 
Pack sizes: 1 tube of 2 g,10 g or 30 g; 1 pump of 30 g. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Galderma International 
Tour Europlaza, 20 avenue André Prothin – La Défense 4 
La Défense Cedex 92927 
France 
 
 



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8. MARKETING AUTHORISATION NUMBER(S) 
 
Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes: 
EU/1/13/904/004 
EU/1/13/904/005 
EU/1/13/904/006 
 
Polypropylene (PP) / Thermoplastic Polyolefin (TPO) / high density polyethylene (HDPE) and 
polypropylene (PP) child resistant closure. 
EU/1/13/904/007 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 21 February 2014 
Date of latest renewal: 22 November 2018 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/ 
 



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ANNEX II 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 



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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Laboratoires Galderma 
Z.I. Montdésir 
74540 Alby-sur-Chéran 
France 
 
And  
 
Galderma Laboratorium GmbH 
Toulouser Allee 19a-23a 
D-40211 Düsseldorf 
Germany 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription for renewable delivery. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety reports for this medicinal product are set out 
in the list of Union reference dates (EURD list) provided for under Article 107c(7) of 
Directive 2001/83/EC and any subsequently updates published on the European medicines 
web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk profile 
or as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached. 

 
 



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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



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A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Mirvaso 3 mg/g gel 
brimonidine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One gram of gel contains 3.3 mg of brimonidine. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium 
dioxide, propylene glycol (E1520), sodium hydroxide, purified water. See leaflet for further 
information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Gel 
2g 
10 g 
30 g 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Do not swallow. 
Read the package leaflet before use. 
Cutaneous use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



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9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Galderma International 
Tour Europlaza, 20 avenue André Prothin 
La Défense 4 
92927 La Défense Cedex 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/904/004 
EU/1/13/904/005 
EU/1/13/904/006 
EU/1/13/904/007 
 
 
13. BATCH NUMBER 
 

Lot 
 

 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Mirvaso 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



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PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
30 G TUBE / MULTIDOSE CONTAINER WITH AIRLESS PUMP 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Mirvaso 3 mg/g gel 
brimonidine 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One gram of gel contains 3.3 mg of brimonidine. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium 
dioxide, propylene glycol, sodium hydroxide, purified water. See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Gel 
30 g 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Do not swallow. 
Read the package leaflet before use. 
Cutaneous use only. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not freeze 
 
 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/13/904/006 
EU/1/13/904/007 
 
13. BATCH NUMBER 
 

Lot 
 

 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
10 G TUBE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Mirvaso 3 mg/g gel 
brimonidine 
Cutaneous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
Do not swallow. 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 g 
 
 
6. OTHER 
 
Keep out of the sight and reach of children. 
 
Excipients: Carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium 
dioxide, propylene glycol, sodium hydroxide, purified water. 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
2 G TUBE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Mirvaso 3 mg/g gel 
brimonidine 
Cutaneous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
Do not swallow. 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2 g 
 
 
6. OTHER 
 



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B. PACKAGE LEAFLET 



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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 
 
1. What Mirvaso is and what it is used for 
2. What you need to know before you use Mirvaso 
3. How to use Mirvaso 
4. Possible side effects 
5. How to store Mirvaso 
6. 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. 



23 

- 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. 
 



24 

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. 
 
 



25 

[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. 

 
 
 



26 

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 



27 

 
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 
 



28 

or  
 
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 



29 

  
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. 

 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET