Amisulpride Zentiva 100 mg
Amisulpride Zentiva 100 mg is a medicine authorised by Swissmedic under authorisation number 59423. 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 25 September 2008 and the authorisation is valid without a time limit. ATC code N05AL05 places the medicine in the group Psycholeptics.
| Authorisation number | 59423 |
|---|---|
| Name | Amisulpride Zentiva 100 mg |
| Full name | Amisulpride Zentiva 100 mg, teilbare Tabletten |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N05AL05 |
| First authorisation | 25 September 2008 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Amisulpride Zentiva 100 mg, teilbare Tabletten | B | 25 September 2008 |
| 2 | Amisulpride Zentiva 200 mg, teilbare Tabletten | B | 25 September 2008 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 7 | 30 | Tablette(n) | N05AL05 | 01.05.0. | B |
| 8 | 90 | Tablette(n) | N05AL05 | 01.05.0. | B |
| 9 | 30 | Tablette(n) | N05AL05 | 01.05.0. | B |
| 10 | 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 100 mg authorised in Switzerland?
Yes. Amisulpride Zentiva 100 mg is authorised by Swissmedic under authorisation number 59423, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Amisulpride Zentiva 100 mg have?
Amisulpride Zentiva 100 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 100 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.