Praluent 75 mg
Praluent 75 mg is a medicine authorised by Swissmedic under authorisation number 65882. The authorisation holder is Sanofi-Aventis (Suisse) SA. The medicinal product code is Biotechnological 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 22 April 2016 and the authorisation is valid without a time limit. ATC code C10AX14 places the medicine in the group Lipid modifying agents.
| Authorisation number | 65882 |
|---|---|
| Name | Praluent 75 mg |
| Full name | Praluent 75 mg, solution injectable en stylo prérempli |
| Authorisation holder | Sanofi-Aventis (Suisse) SA |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | C10AX14 |
| First authorisation | 22 April 2016 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Praluent 75 mg, solution injectable en stylo prérempli | B | 22 April 2016 |
| 2 | Praluent 150 mg, solution injectable en stylo prérempli | B | 22 April 2016 |
| 3 | Praluent 300 mg, solution injectable en stylo prérempli | B | 18 November 2025 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 2 | 2 | stylos pré-remplis avec bouton d'activation à 1 ml | C10AX14 | 07.12.0. | B |
| 3 | 6 | stylos pré-remplis avec bouton d'activation à 1 ml | C10AX14 | 07.12.0. | B |
| 7 | 1 | stylo pré-rempli avec bouton d'activation à 1 ml | C10AX14 | 07.12.0. | B |
| 8 | 1 | stylo pré-rempli sans bouton d'activation à 1 ml | C10AX14 | 07.12.0. | B |
| 9 | 2 | stylos pré-remplis sans bouton d'activation à 1 ml | C10AX14 | 07.12.0. | B |
| 5 | 2 | stylos pré-remplis avec bouton d'activation à 1 ml | C10AX14 | 07.12.0. | B |
| 6 | 6 | stylos pré-remplis avec bouton d'activation à 1 ml | C10AX14 | 07.12.0. | B |
| 10 | 2 | stylos pré-remplis sans bouton d'activation à 1 ml | C10AX14 | 07.12.0. | B |
| 11 | 1 | stylo pré-rempli sans bouton d'activation à 2 ml | C10AX14 | 07.12.0. | B |
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Other medicines from this authorisation holder
Frequently asked questions
Is Praluent 75 mg authorised in Switzerland?
Yes. Praluent 75 mg is authorised by Swissmedic under authorisation number 65882, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Praluent 75 mg have?
Praluent 75 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 Praluent 75 mg?
The authorisation holder is Sanofi-Aventis (Suisse) 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.