Spinraza 12mg/5ml
Spinraza 12mg/5ml is a medicine authorised by Swissmedic under authorisation number 66495. The authorisation holder is Biogen Switzerland AG. The medicinal product code is Transplant: gene therapy product and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 20 September 2017 and the authorisation is valid without a time limit. ATC code M09AX places the medicine in the group Other drugs for disorders of the musculo-skeletal system.
| Authorisation number | 66495 |
|---|---|
| Name | Spinraza 12mg/5ml |
| Full name | Spinraza 12mg/5ml, Injektionslösung zur intrathekalen Injektion |
| Authorisation holder | Biogen Switzerland AG |
| Medicinal product code | Transplant: gene therapy product |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | M09AX |
| First authorisation | 20 September 2017 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Spinraza 12mg/5ml, Injektionslösung zur intrathekalen Injektion | A | 20 September 2017 |
| 2 | Spinraza 28mg/5ml, Injektionslösung zur intrathekalen Injektion | A | 19 February 2026 |
| 3 | Spinraza 50mg/5ml, Injektionslösung zur intrathekalen Injektion | A | 19 February 2026 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 5 ml | Durchstechflasche(n) | M09AX | 01.99.0. | A |
| 2 | 5 ml | Durchstechflasche(n) | M09AX | 01.99.0. | A |
| 3 | 5 ml | Durchstechflasche(n) | M09AX | 01.99.0. | A |
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Other medicines from this authorisation holder
Frequently asked questions
Is Spinraza 12mg/5ml authorised in Switzerland?
Yes. Spinraza 12mg/5ml is authorised by Swissmedic under authorisation number 66495, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Spinraza 12mg/5ml have?
Spinraza 12mg/5ml is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.
Who is the authorisation holder of Spinraza 12mg/5ml?
The authorisation holder is Biogen Switzerland 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.