Opzelura 15 mg/g
Opzelura 15 mg/g is a medicine authorised by Swissmedic under authorisation number 69443. The authorisation holder is Incyte Biosciences International Sàrl. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 30 January 2025 and the authorisation is limited until 29 January 2030. ATC code D11AH09 places the medicine in the group Other dermatological preparations.
| Authorisation number | 69443 |
|---|---|
| Name | Opzelura 15 mg/g |
| Full name | Opzelura 15 mg/g, crème |
| Authorisation holder | Incyte Biosciences International Sàrl |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | D11AH09 |
| First authorisation | 30 January 2025 |
| Authorisation validity | 29 January 2030 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Opzelura 15 mg/g, crème | B | 30 January 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 100 | g | D11AH09 | 10.99.0. | B |
| 2 | 100 | g | D11AH09 | 10.99.0. | B |
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Other medicines from this authorisation holder
Frequently asked questions
Is Opzelura 15 mg/g authorised in Switzerland?
Yes. Opzelura 15 mg/g is authorised by Swissmedic under authorisation number 69443, data as of 01 September 2026. The authorisation is limited until 29 January 2030.
Which dispensing category does Opzelura 15 mg/g have?
Opzelura 15 mg/g is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Opzelura 15 mg/g?
The authorisation holder is Incyte Biosciences International Sàrl. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.