Amisulpride Zentiva 400 mg
Amisulpride Zentiva 400 mg is a medicine authorised by Swissmedic under authorisation number 62398. 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 06 July 2011 and the authorisation is valid without a time limit. ATC code N05AL05 places the medicine in the group Psycholeptics.
| Authorisation number | 62398 |
|---|---|
| Name | Amisulpride Zentiva 400 mg |
| Full name | Amisulpride Zentiva 400 mg, teilbare Filmtabletten |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N05AL05 |
| First authorisation | 06 July 2011 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Amisulpride Zentiva 400 mg, teilbare Filmtabletten | B | 06 July 2011 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | Tablette(n) | N05AL05 | 01.05.0. | B |
| 2 | 90 | Tablette(n) | N05AL05 | 01.05.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Amisulpride Zentiva 400 mg authorised in Switzerland?
Yes. Amisulpride Zentiva 400 mg is authorised by Swissmedic under authorisation number 62398, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Amisulpride Zentiva 400 mg have?
Amisulpride Zentiva 400 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 Amisulpride Zentiva 400 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.