Leflunomide Zentiva 10 mg
Leflunomide Zentiva 10 mg is a medicine authorised by Swissmedic under authorisation number 62248. The authorisation holder is Helvepharm AG. The medicinal product code is Synthetic medicines and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 09 June 2011 and the authorisation is valid without a time limit. ATC code L04AA13 places the medicine in the group Immunosuppressants.
| Authorisation number | 62248 |
|---|---|
| Name | Leflunomide Zentiva 10 mg |
| Full name | Leflunomide Zentiva 10 mg, Filmtabletten |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | L04AA13 |
| First authorisation | 09 June 2011 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Leflunomide Zentiva 10 mg, Filmtabletten | A | 09 June 2011 |
| 2 | Leflunomide Zentiva 20 mg, Filmtabletten | A | 09 June 2011 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | Tablette(n) | L04AA13 | 07.10.6. | A |
| 2 | 100 | Tablette(n) | L04AA13 | 07.10.6. | A |
| 3 | 30 | Tablette(n) | L04AA13 | 07.10.6. | A |
| 4 | 100 | Tablette(n) | L04AA13 | 07.10.6. | A |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Leflunomide Zentiva 10 mg authorised in Switzerland?
Yes. Leflunomide Zentiva 10 mg is authorised by Swissmedic under authorisation number 62248, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Leflunomide Zentiva 10 mg have?
Leflunomide Zentiva 10 mg is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.
Who is the authorisation holder of Leflunomide Zentiva 10 mg?
The authorisation holder is Helvepharm AG. 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.