Fluconazol Zentiva 50 mg
Fluconazol Zentiva 50 mg is a medicine authorised by Swissmedic under authorisation number 56978. The authorisation holder is Helvepharm AG. 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 19 January 2005 and the authorisation is valid without a time limit. ATC code J02AC01 places the medicine in the group Antimycotics for systemic use.
| Authorisation number | 56978 |
|---|---|
| Name | Fluconazol Zentiva 50 mg |
| Full name | Fluconazol Zentiva 50 mg, Kapseln |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | J02AC01 |
| First authorisation | 19 January 2005 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Fluconazol Zentiva 50 mg, Kapseln | B | 19 January 2005 |
| 2 | Fluconazol Zentiva 150 mg, Kapseln | B | 19 January 2005 |
| 3 | Fluconazol Zentiva 200 mg, Kapseln | B | 19 January 2005 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 2 | 7 | Kapsel(n) | J02AC01 | 08.06.0. | B |
| 4 | 28 | Kapsel(n) | J02AC01 | 08.06.0. | B |
| 6 | 1 | Kapsel(n) | J02AC01 | 08.06.0. | B |
| 8 | 4 | Kapsel(n) | J02AC01 | 08.06.0. | B |
| 10 | 2 | Kapsel(n) | J02AC01 | 08.06.0. | B |
| 12 | 7 | Kapsel(n) | J02AC01 | 08.06.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Fluconazol Zentiva 50 mg authorised in Switzerland?
Yes. Fluconazol Zentiva 50 mg is authorised by Swissmedic under authorisation number 56978, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Fluconazol Zentiva 50 mg have?
Fluconazol Zentiva 50 mg 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 Fluconazol Zentiva 50 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.