Esketamin Sintetica 5 mg/ml
Esketamin Sintetica 5 mg/ml is a medicine authorised by Swissmedic under authorisation number 67994. The authorisation holder is Sintetica SA. 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 November 2021 and the authorisation is valid without a time limit. ATC code N01AX14 places the medicine in the group Anesthetics.
| Authorisation number | 67994 |
|---|---|
| Name | Esketamin Sintetica 5 mg/ml |
| Full name | Esketamin Sintetica 5 mg/ml, soluzione iniettabile o per infusione |
| Authorisation holder | Sintetica SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N01AX14 |
| First authorisation | 19 November 2021 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Esketamin Sintetica 5 mg/ml, soluzione iniettabile o per infusione | B | 19 November 2021 |
| 2 | Esketamin Sintetica 25 mg/ml, soluzione iniettabile o per infusione | B | 19 November 2021 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 10 x 5 ml | Ampulle(n) | N01AX14 | 01.02.1. | B |
| 2 | 10 x 2 ml | Ampulle(n) | N01AX14 | 01.02.1. | B |
| 3 | 10 x 10 ml | Ampulle(n) | N01AX14 | 01.02.1. | B |
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Frequently asked questions
Is Esketamin Sintetica 5 mg/ml authorised in Switzerland?
Yes. Esketamin Sintetica 5 mg/ml is authorised by Swissmedic under authorisation number 67994, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Esketamin Sintetica 5 mg/ml have?
Esketamin Sintetica 5 mg/ml 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 Esketamin Sintetica 5 mg/ml?
The authorisation holder is Sintetica SA. 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.