ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Vaniqa 11.5% cream
2.
Each gram of Vaniqa 11.5% w/w cream contains 115 mg eflornithine (as hydrochloride monohydrate).
Excipients:
Cetostearyl alcohol
Stearyl alcohol.
For a full list of excipients, see section 6.1.
3.
Cream.
White to off white cream
4.
Treatment of facial hirsutism in women.
A thin layer of the cream should be applied to clean and dry affected areas twice daily, at least eight
hours apart. The cream should be rubbed in thoroughly. Hands should be washed after applying this
medicine. For maximal efficacy, the treated area should not be cleansed within four hours of
application. Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than
five minutes after application.
Efficacy has only been demonstrated for affected areas of the face and under the chin. Application
should be limited to these areas. The product should be applied such that no visual residual product
remains on the treated areas after rub-in. Maximal applied doses used safely in clinical trials were up
to 30 grams per month.
Improvement in the condition may be noticed within eight weeks of starting treatment.
Continued treatment may result in further improvement and is necessary to maintain beneficial effects.
The condition may return to pre-treatment levels within eight weeks following discontinuation of
treatment.
Use should be discontinued if no beneficial effects are noticed within four months of commencing
therapy.
Patients may need to continue to use a hair removal method (e.g. shaving or plucking) in conjunction
with Vaniqa. In that case, the cream should be applied no sooner than five minutes after shaving or use
of other hair removal methods, as increased stinging or burning may otherwise occur.
Elderly:
(> 65 years) no dosage adjustment is necessary.
Children and Adolescents:
(< 12 years) safety and efficacy of Vaniqa have not been established.
Hepatic/renal impairment:
the safety and efficacy of Vaniqa in women with hepatic or renal
impairment have not been established.
2
Hypersensitivity to eflornithine or to any of the excipients (see section 6.1).
Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome,
androgen secreting neoplasm) or certain medications (e.g. cyclosporin, glucocorticoids, minoxidil,
phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy). These
factors should be considered in the overall medical treatment of patients who might be prescribed
Vaniqa.
Vaniqa is for cutaneous use only. Contact with eyes or mucous membranes (e.g. nose or mouth)
should be avoided. Transient stinging or burning may occur when the cream is applied to abraded or
broken skin.
If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to
once a day. If irritation continues, treatment should be discontinued and the physician consulted.
It is recommended that hands are washed following use.
As the safety of Vaniqa has not been studied in patients with severe renal impairment, caution should
be used when prescribing Vaniqa for these patients.
This product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions
(e.g. contact dermatitis).
No interaction studies have been performed.
Pregnancy:
Throughout clinical trials data from a limited number of exposed pregnancies (22)
indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or
foetuses. Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred
while the patient was using Vaniqa. Of these 19 pregnancies, there were 9 healthy infants, 5 elective
abortions, 4 spontaneous abortions and 1 birth defect (Down’s Syndrome to a 35 year old). To date, no
other relevant epidemiological data are available. Animal studies have shown reproductive toxicity
(see section 5.3). The potential risk to humans is unknown. Therefore, women who are pregnant or
planning pregnancy should use an alternative means to manage facial hair.
Lactation:
it is not known if eflornithine is excreted in human milk. Women should not use Vaniqa
whilst breast-feeding.
No studies on the effects on the ability to drive and use machines have been performed. No effect is
expected.
The mostly skin related adverse reactions reported were primarily mild in intensity and resolved
without discontinuation of Vaniqa or initiation of medical treatment. The most frequently reported
undesirable effect was acne, which was generally mild. In the vehicle controlled trials (n= 594), acne
was observed in 41% of patients at baseline; 7% of patients treated with Vaniqa and 8% treated with
vehicle experienced a worsening of their condition. Of those with no acne at baseline, similar
percentages (14%) reported acne following treatment with Vaniqa or vehicle.
The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to
MedDRA convention. MedDRA conventions for frequency are very common (> 10%), common
(> 1% to < 10%), uncommon (> 0.1% to < 1%), rare (> 0.01% to < 0.1%), or very rare (< 0.01%),
including isolated reports. Note that over 1350 patients were treated with Vaniqa in these trials for
6 months to one year, while only slightly more than 200 patients were treated with vehicle for
6 months. Most events were reported at similar rates between Vaniqa and vehicle. The skin effects of
3
burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients
compared to vehicle, as indicated by the asterisk (*).
Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency
convention).
Skin and subcutaneous tissue disorders
Very common
(> 10%)
Acne
Common
(> 1% to < 10%)
Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin,
pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis
Uncommon
(> 0.1% to < 1%)
Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding
skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis,
abnormal hair texture and abnormal hair growth, hypopigmentation, flushing
skin, lip numbness, skin soreness
Rare
(> 0.01% to < 0.1%)
Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin
cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness
Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
However, should very high dose cutaneous administration or accidental oral ingestion occur, attention
should be paid to the effects seen with therapeutic doses of intravenous eflornithine (400 mg/kg/day or
approximately 24 g/day) used in the treatment of
Trypanosoma brucei gambiense
infection (African
sleeping sickness): hair loss, facial swelling, seizures, hearing impairment, gastrointestinal
disturbance, loss of appetite, headache, weakness, dizziness, anaemia, thrombocytopenia and
leucopenia.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: other dermatologicals, ATC code: D11A X.
Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the
hair shaft by the hair follicle. Vaniqa has been shown to reduce the rate of hair growth.
The safety and efficacy of Vaniqa was evaluated in two double-blind, randomised, vehicle-controlled
clinical trials involving 594 women of skin types I-VI (393 on Vaniqa, 201 on vehicle) treated for up
to 24 weeks. Physicians assessed the change from baseline on a 4-point scale, 48 hours after women
had shaved the treated areas of the affected areas of the face and under the chin, considering
parameters such as hair length and density, and darkening of the skin associated with the presence of
terminal hair. Improvement was seen as early as 8 weeks after initiation of treatment.
The combined results of these two trials are presented below:
Outcome*
Vaniqa 11.5% cream
Vehicle
0%
9%
33%
58%
* At end of therapy (Week 24). For patients who discontinued therapy during the
trial last observations were carried forward to Week 24.
6%
29%
35%
30%
4
Clear / almost clear
Marked improvement
Improved
No improvement / worse
Statistically significant (p ≤ 0.001) improvement for Vaniqa versus vehicle was seen in each of these
studies for women with marked improvement and clear/almost clear responses. These improvements
resulted in a corresponding reduction in the darkening appearance of the facial skin associated with the
presence of terminal hair. Subgroup analysis revealed a difference in treatment success where 27% of
non-white women and 39% of white women showed a marked or better improvement. Subgroup
analysis also showed that 29% of obese women (BMI ≥ 30) and 43% of normal weight women
(BMI < 30) showed a marked or better improvement. About 12% of women in the clinical trials were
postmenopausal. Significant improvement (p < 0.001) versus vehicle was seen in postmenopausal
women.
Patient self-assessments demonstrated a significantly reduced psychological discomfort with the
condition, as measured by responses to 6 questions on a visual analogue scale. Vaniqa significantly
reduced how bothered patients felt by their facial hair and by the time spent removing, treating, or
concealing facial hair. Patient comfort in various social and work settings was also improved. Patient
self-assessments were found to correlate with physician observations of efficacy. These patient-
observable differences were seen 8 weeks after initiating treatment.
The condition returned to pre-treatment levels within eight weeks after discontinuation of treatment.
5.2 Pharmacokinetic properties
Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving
women was 0.8%.
The steady state plasma half-life of eflornithine was approximately 8 hours. Steady state was reached
within four days. The steady state peak and trough plasma concentrations of eflornithine were
approximately 10 ng/ml and 5 ng/ml, respectively. The steady state 12-hour area under the plasma
concentration versus time curve was 92.5 ng.hr/ml.
Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose
toxicity, genotoxicity and carcinogenic potential, including one photocarcinogenicity study in mice.
In a dermal fertility study in rats, no adverse effects on fertility were observed at up to 180 times the
human dose. In dermal teratology studies, no teratogenic effects were observed in rats and rabbits at
doses up to 180 and 36 times the human dose, respectively. Higher doses resulted in maternal and
foetal toxicity without evidence of teratogenicity.
5
6.
6.1 List of excipients
Cetostearyl alcohol;
Macrogol cetostearyl ether;
Dimeticone;
Glyceryl stearate;
Macrogol stearate;
Methyl parahydroxybenzoate (E218);
Liquid paraffin;
Phenoxyethanol;
Propyl parahydroxybenzoate (E216);
Purified water
Stearyl alcohol
Sodium hydroxide (E524) (to adjust pH)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of
cream. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7.
Almirall
,
S.A.
Ronda General Mitre, 151,
08022
Barcelona,
Spain.
8.
EU/1/01/173/001-003
9.
20 March 2001 / 20 March 2006
6
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER(S)
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
8
A
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
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 OF THE MARKETING AUTHORISATION
•
Medicinal product subject to medical prescription
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable
9
ANNEX III
LABELLING AND PACKAGE LEAFLET
10
A. LABELLING
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
OUTER CARTON TEXT
1.
Vaniqa 11.5% cream
Eflornithine
2.
STATEMENT OF ACTIVE SUBSTANCE
Each gram of cream contains 115 mg eflornithine (as hydrochloride monohydrate).
3.
LIST OF EXCIPIENTS
Also contains: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol
stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl
parahydroxybenzoate (E216); purified water, stearyl alcohol and sodium hydroxide (to adjust pH).
4.
15 g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cutaneous use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP MM/YYYY
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
12
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain.
EU/1/01/173/001
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Vaniqa
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Vaniqa 11.5% cream
Eflornithine
2.
Almirall, S.A.,
3.
METHOD OF ADMINISTRATION
Cutaneous use
Read the package leaflet before use.
4.
EXPIRY DATE
EXP MM/YYYY
5.
BATCH NUMBER
Batch
6.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
15 g
7.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
8.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
14
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
OUTER CARTON TEXT
1.
Vaniqa 11.5% cream
Eflornithine
2.
STATEMENT OF ACTIVE SUBSTANCE
Each gram of cream contains 115 mg eflornithine (as hydrochloride monohydrate).
3.
LIST OF EXCIPIENTS
Also contains: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol
stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl
parahydroxybenzoate (E216); purified water, stearyl alcohol and sodium hydroxide (to adjust pH).
4.
30 g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cutaneous use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP MM/YYYY
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
15
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Marketing Authorisation Holder:
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain.
12. MARKETING AUTHORISATION NUMBER (S)
EU/1/01/173/002
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Vaniqa
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Vaniqa 11.5% cream
Eflornithine
2.
Almirall, S.A.,
3.
METHOD OF ADMINISTRATION
Cutaneous use
Read the package leaflet before use.
4.
EXPIRY DATE
EXP MM/YYYY
5.
BATCH NUMBER
Batch
6.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
30 g
7.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
8.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
17
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE
PACKAGING
OUTER CARTON TEXT
1.
Vaniqa 11.5% cream
Eflornithine
2.
STATEMENT OF ACTIVE SUBSTANCE
Each gram of cream contains 115 mg eflornithine (as hydrochloride monohydrate).
3.
LIST OF EXCIPIENTS
Also contains: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol
stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl
parahydroxybenzoate (E216); purified water, stearyl alcohol and sodium hydroxide (to adjust pH).
4.
60 g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cutaneous use
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP MM/YYYY
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
18
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Marketing Authorisation Holder:
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain.
EU/1/01/173/003
13. BATCH NUMBER
Batch
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Vaniqa
19
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Vaniqa 11.5% cream
Eflornithine
2.
Almirall, S.A.,
3.
METHOD OF ADMINISTRATION
Cutaneous use
Read the package leaflet before use.
4.
EXPIRY DATE
EXP MM/YYYY
5.
BATCH NUMBER
Batch
6.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
60 g
7.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
8.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
Vaniqa 11.5% cream
(eflornithine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1.
What Vaniqa is and what it is used for
2.
Before you use Vaniqa
4.
Possible side effects
5.
How to store Vaniqa
6.
Further information
1.
WHAT Vaniqa IS AND WHAT IT IS USED FOR
Women use Vaniqa to reduce the growth of excessive hair on their faces.
How it works
Vaniqa slows down the growth of hair through its effect on an enzyme involved in the production of
hair. It does not remove hair. It is not a depilatory cream so you may need to continue removing hair,
for example by shaving or plucking. Improvement may be seen as early as 2 months after start up of
treatment. If you do not see any benefit after using it for 4 months contact your doctor. If you stop
using it your original hair growth may return in 2 months.
2.
BEFORE YOU USE Vaniqa
Do NOT use Vaniqa:
•
if you are allergic (hypersensitive) to eflornithine or to any of the other ingredients.
Take special care with Vaniqa:
•
Before using Vaniqa, tell your doctor of any other medical problems (especially related to
your kidneys or liver).
•
If you are unsure whether or not to use this medicine contact your doctor or pharmacist for
advice.
What else should I know?
Excessive growth of hair may be a result of underlying diseases or certain medications. Contact your
doctor if you have any questions.
22
3.
How to use Vaniqa
Wait at least 5 minutes after shaving or plucking before using this cream. It may sting or burn if you
put this medicine on cut or irritated skin.
Do not get it in your eyes or inside your nose or mouth. If this happens accidentally, rinse thoroughly
with water.
Using Vaniqa with other medicines
Speak to your doctor if you need to use other medicines on the areas of skin where you are using it.
Pregnancy and Breast-feeding
Do not use Vaniqa if you are pregnant, or trying to become pregnant. You should not use this
medicine while breast-feeding.
Important information about some of the ingredients of Vaniqa
This medicine contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions
(e.g. contact dermatitis).
3.
HOW TO USE Vaniqa
Always use Vaniqa exactly as your doctor has instructed you. You should check with your doctor or
pharmacist if you are unsure.
1.
If you have just shaved or used any other hair removal method, wait at least 5 minutes before
using Vaniqa.
2.
Clean and dry the areas of the skin where you will be using it.
3.
If possible, do not wash these areas of skin for 4 hours after putting it on.
5.
Wash your hands after applying it.
6.
Wait at least 5 minutes before using make-up or sunscreen on the same areas.
7.
Use it twice a day, at least 8 hours apart.
8.
Vaniqa can cause irritation (stinging, burning). If irritation is caused, reduce the use of Vaniqa
to once a day until the irritation has gone. If irritation persists contact your doctor.
How long should I use Vaniqa?
It may take up to 2 months before you see results. Continually using it may lead to further
improvement. You will need to keep using it to keep the benefit. If you do not see any benefit after
using it for 4 months contact your doctor.
If you use more Vaniqa than you should
If you put too much cream on your skin, it is unlikely to harm you.
If you or anyone else accidentally swallows Vaniqa, contact your doctor.
If you forget to use Vaniqa
Apply straight away, but wait at least 8 hours before using it again.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Vaniqa can cause side effects, although not everybody gets them. The most
frequently reported side effect was acne (7-14%). Other side effects commonly (> 1%) reported were
23
4.
Apply a thin layer of cream and rub it in thoroughly.
skin problems such as skin reactions from ingrowing hair, hair loss, a burning, stinging or tingling
feeling, dry skin, itching, redness or rash.
Also reported, but uncommonly (< 1%), were ingrowing hairs, swelling of the face or mouth, skin
bleeding, cold sores, dry, cracked or numb lips, pale areas of the skin, sore skin, flushing of the skin,
eczema, irritation of the skin, skin boils, abnormal hair texture and abnormal hair growth.
Also reported, but rarely (<0.1%), rosacea (inflammation and flushing of the skin, and can also cause
pus under the skin), a red, scaly, itchy dermatitis, abnormal skin growth, red bumpy rash, skin cysts,
blistering rash, excessive hair growth, skin tightness, other skin disorders.
If you notice these or any other side effects, or if you are not sure about the effect of Vaniqa, contact
your doctor or pharmacist.
5.
HOW TO STORE Vaniqa
Keep out of the reach and sight of children.
Do not use the cream after its expiry date. There is an expiry date on the box and on the bottom of the
tube of Vaniqa.
Make sure the cap of the tube is tightly closed after each use.
Do not store above 25°C (77°F).
6.
FURTHER INFORMATION
What Vaniqa contains
The active substance is Eflornithine. Each gram of Vaniqa 11.5% cream contains 115 mg of
eflornithine (as hydrochloride monohydrate).
The other ingredients are Cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl
stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol;
propyl parahydroxybenzoate (E216); purified water and stearyl alcohol. Tiny amounts of sodium
hydroxide (E524) are sometimes added to keep acidity levels (pH levels) normal.
What Vaniqa looks like and the contents of the pack
Vaniqa is a cream which is white to off white in colour. It is supplied in tubes of 15 g, 30 g and 60 g
but not all pack sizes may be marketed.
Marketing Authorisation Holder
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain.
Tel: + 34 93 291 30 00
Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465 Reinbek
Germany
24
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder:
Belgique/België/Belgien,
Italia
Almirall N.V.
Medialaan 32 B 4
B-1800 Vilvoorde
Belgien / Belgique
Tél/Tel: +32 (0)2 257 26 63
Almirall SpA
Via Messina 38, Torre C
20154 Milano (Italia)
Tel.: +39 02 346181
България / Česká republika / Danmark / Eesti
/ Ελλάδα / España / Ísland / Κύπρος / Latvija /
Lietuva / Magyarország / Malta / Nederland /
Norge / Polska / România / Slovenija /
Slovenská republika / Suomi/Finland / Sverige
Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Испания / Španělsko / Spanien / Hispaania /
Ισπανία / España / Spánn / Ισπανία / Spānija /
Ispanija / Spanyolország / Spanja / Spanje / Spania
/ Hiszpania / Spania / Španija / Španielsko /
Espanja / Spanien
Teл/Tel/Tlf/Tηλ/Sími/Puh: +34 93 291 30 00
Ireland / United Kingdom
Almirall Limited
Pinewood
Chineham Business Park
Crockford Lane, Chineham
Basingstoke, RG24 8AL
United Kingdom
Tel.: +44 (0) 1256 698037
Deutschland
Luxembourg/Luxemburg
Österreich
Almirall GmbH
Wien
Tel.: +43 01/595 39 60
Almirall Hermal GmbH
Scholtzstrasse 3
21465 Reinbek
Deutschland/ Allemagne
Tel./ Tél: +49 (040) 72704-0
France
Almirall SAS
1, boulevard Victor
75015 Paris
Tél.: +33(0)1 46 46 19 20
Portugal
Almirall - Produtos Farmacêuticos, Lda.
Rua João Chagas, 53A, 2º andar - escritório 201,
1495-072 Algés
Tel.: +351 21 415 57 50
This leaflet was last approved on {month year}
25
Source: European Medicines Agency
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