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Skinoren cream (azelaic acid 200 mg/g) – not marketed in Serbia: information and alternatives
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-1280x1280-350x350.webp "KIREI AZELAIC ACID 10% CREAM 50 ML")
- Stock: Zabrana online prodaje
- Brand: BAYER products
- Model: BR-2938
This medicine is currently not marketed in Serbia
- Skinoren cream currently has no valid marketing authorisation in Serbia (ALIMS) and cannot be obtained in Serbian pharmacies, including ApotekaOnline.
- The last Serbian authorisation (Bayer, 515-01-00786-16-001 of 25 October 2016, prescription-only) no longer appears in the National Register of Medicines 2021 or in the ALIMS lists of renewed authorisations for 2021–2026.
- Always talk to your doctor (dermatologist) about continuing or replacing the treatment. Do not change your treatment on your own.
- This page is for information only and is not an offer to buy the medicine.
Skinoren cream is a medicine for use on the skin containing azelaic acid at a concentration of 200 mg per 1 g of cream (20%). It belongs to the group of topical anti-acne preparations (ATC D10AX03).
In EU countries where it is authorised, for example Croatia (marketing authorisation holder LEO Pharma A/S), Skinoren cream is indicated, according to the official Summary of Product Characteristics (HALMED), for the treatment of acne (acne vulgaris) and melasma. In Serbia it was previously authorised only for the topical treatment of acne. All information on this page comes from the official documents listed in the sources.
What is Skinoren cream, what is it used for and what is available in Serbia?
Key facts about the medicine
| Medicine name | Skinoren®, 200 mg/g, cream |
|---|---|
| Active substance | azelaic acid |
| Strength | 200 mg/g (20%) |
| Pharmaceutical form | cream for cutaneous use |
| Therapeutic group | anti-acne preparations for topical use (D10AX03) |
| Pack | tube containing 30 g of cream |
| Marketing authorisation holder | in Croatia: LEO Pharma A/S, Denmark; previously in Serbia: Bayer (manufacturer Bayer HealthCare Manufacturing S.r.l., Italy) |
| Status in Serbia | no valid authorisation – not marketed (previously prescription-only) |
What is Skinoren used for in countries where it is authorised?
According to the Croatian Summary of Product Characteristics (HALMED, revision 20 July 2023), Skinoren cream is indicated for:
- the treatment of acne (acne vulgaris)
- the treatment of melasma (dark patches – skin hyperpigmentation)
It is intended for adults and adolescents aged 12 years and older; safety and efficacy in children under 12 have not been established. The patient leaflet previously approved in Serbia (2016) listed only the topical treatment of acne.
How is it used?
The cream is for external use only, on affected skin that has been cleaned and dried. The official documents describe application twice daily (morning and evening), rubbed in gently; about 2.5 cm of cream is usually enough for the whole face. In acne, improvement is usually seen after about 4 weeks; in melasma, at least 3 months of use is foreseen, together with mandatory sun protection (UVA and UVB).
This describes the official product information and is not an individual recommendation – the way and duration of use are decided by the doctor according to the official instructions.
Important safety information from the official documents
- The medicine must not be used in case of hypersensitivity to azelaic acid or to any of the excipients.
- Avoid contact with the eyes, mouth and other mucous membranes; if the cream gets into the eye, rinse with plenty of water and see a doctor if irritation persists. Wash your hands after each application.
- The cream contains propylene glycol, benzoic acid and cetostearyl alcohol, which may cause local irritation or contact dermatitis.
- In rosacea, alcohol-based cleansers, tinctures, astringents and abrasives should be avoided.
- Worsening of asthma has been reported rarely after marketing.
- The most common side effects are burning, itching and redness at the application site; local irritation usually settles during use.
- Pregnancy and breastfeeding: caution is required; during breastfeeding the infant must not come into contact with treated skin or the breast.
What is available in Serbia?
No medicine containing azelaic acid was found in the National Register of Medicines 2021 or in the ALIMS lists of new and renewed authorisations for 2021–2026. This means that there is currently no authorised medicine in Serbia that is a direct replacement for Skinoren cream.
| Option | What it is | Note |
|---|---|---|
| Other authorised medicines for topical acne treatment | medicines with other active substances, prescription or non-prescription | the choice of medicine, strength and duration of treatment is made by the doctor (dermatologist) according to the type and severity of acne |
| Dermocosmetics with azelaic acid | cosmetic products, usually with about 10% azelaic acid | they are not medicines and do not replace Skinoren 20%; they can be part of the daily care of skin prone to acne and redness |
| SPF 50 sun protection | cosmetic skin protection | especially important in melasma and during acne treatment |
Replacement of a medicine is always decided by the doctor. A pharmacist can help you choose suitable skin care, but cannot replace treatment prescribed by a doctor.
Pharmacist's advice
If you have been using Skinoren, do not switch to another acne medicine on your own – see a dermatologist, who will assess your skin and choose a treatment available in Serbia. Cosmetic products with azelaic acid contain a lower concentration and are meant for skin care, not for treatment.
Whatever the treatment, cleanse skin prone to acne and dark patches with a mild cleanser, do not rub it harshly and use high-factor sun protection every day.
Availability and price
Skinoren cream is currently not marketed in Serbia and cannot be bought in pharmacies, including ApotekaOnline. No price is available because the medicine has no valid authorisation.
This page is for information only. Talk to your doctor about treatment and replacement, and ask a pharmacy about the availability of other medicines and skin-care products.
Related information
For additional care and support with acne, see also the Acne, pimples and blackheads – products for oily, combination and problem skin category – products in this category do not replace the medicine you have been prescribed.
Composition, packaging and manufacturer
- Active substance: azelaic acid, 200 mg per 1 g of cream.
- Excipients with known effect (per 1 g of cream): propylene glycol 125 mg, benzoic acid 2 mg, cetostearyl alcohol 11.5 mg.
- Pack: aluminium tube containing 30 g of cream.
- Marketing authorisation holder in Croatia: LEO Pharma A/S, Ballerup, Denmark.
- Previously in Serbia: manufacturer Bayer HealthCare Manufacturing S.r.l., Segrate (Milan), Italy.
Storage
- According to the Croatian SmPC: store below 30 °C.
- Shelf life of the unopened pack is 36 months; after first opening, the cream can be used for 6 months.
- Keep out of the reach of children.
Frequently asked questions
Can Skinoren cream be bought in Serbia?
No. Skinoren cream currently has no valid marketing authorisation in Serbia and cannot be obtained in Serbian pharmacies. The last authorisation was issued in 2016 and does not appear in later ALIMS registers and lists of renewed authorisations.
What can replace Skinoren?
No medicine with azelaic acid is currently authorised in Serbia. Other authorised acne medicines with other active substances exist, but the choice of replacement depends on the type and severity of acne and is made by the doctor, usually a dermatologist.
Are cosmetics with azelaic acid the same as Skinoren?
No. Skinoren is a medicine with 20% azelaic acid, while cosmetic products usually contain about 10% and are not registered as medicines. They can be part of the care of skin prone to acne and redness, but they do not replace treatment prescribed by a doctor.
Can Skinoren be used during pregnancy and breastfeeding?
According to the official SmPC, there are no adequate studies in pregnant women, so caution is required and the doctor decides on use. During breastfeeding the infant must not come into contact with treated skin or the breast.
Sources
- HALMED – Summary of Product Characteristics, Skinoren 200 mg/g cream (revision 20 July 2023, Croatian)
- ALIMS – Patient leaflet, Skinoren® cream (authorisation 515-01-00786-16-001 of 25 October 2016, Serbian)
- ALIMS – National Register of Medicines 2019 (Serbian)
- ALIMS – National Register of Medicines 2021 (Serbian)
Sources checked on: 23 October 2026.
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For all orders received up to 12h from Monday to Friday, the approximate delivery time is 2-4 business days for the whole territory of the Republic of Serbia. In case the order is placed on weekends (Saturdays and Sundays), the delivery is done as well as for the orders received on Monday - so next business day.
Deliveries are not made on Saturdays and Sundays.
Additional information
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Delivery restrictions on goods
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Shipping cost
For the territory of the Republic of Serbia:
For goods ordered up to 5.000,00 RSD, delivery charge is 350.00 RSD (VAT included). For goods over 5.000,00 RSD, shipping is free of charge.
For international delivery:
For the export of goods abroad through the PostExport service of Post of Serbia, the shipping price is for:
- Zone I (Slovenia, Croatia, Bosnia and Herzegovina, Montenegro, Northern Macedonia) - 1,280.00 RSD
- Zone II (Other European countries) - 1,790.00 RSD
- Zone III (Asia, Africa, America, Australia and other countries) - 2,650.00 RSD
Delivery time is 15 days or more (depending on the country of delivery)
For export of goods abroad through DHL service, the shipping price is 2,700.00 RSD. Delivery time is 1-5 business days (depending on the country of delivery)
Shipping cost is with tax. The price includes the delivery of the parcel to the buyer's address with the associated tax and customs at the seller's expense. A possible additional cost may be a customs charge against the buyer, depending on the country to which the package is being shipped.
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