ZOLGENSMA
ZOLGENSMA is a medicine authorised by Swissmedic under authorisation number 67529. The authorisation holder is Novartis Pharma Schweiz 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 28 June 2021 and the authorisation is limited until 13 September 2028. ATC code M09AX09 places the medicine in the group Other drugs for disorders of the musculo-skeletal system.
| Authorisation number | 67529 |
|---|---|
| Name | ZOLGENSMA |
| Full name | ZOLGENSMA, Solution for Infusion, |
| Authorisation holder | Novartis Pharma Schweiz AG |
| Medicinal product code | Transplant: gene therapy product |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | M09AX09 |
| First authorisation | 28 June 2021 |
| Authorisation validity | 13 September 2028 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | ZOLGENSMA, Solution for Infusion, | A | 28 June 2021 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 2 x 8,3 ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 2 | 2x5.5ml/1x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 3 | 1x5.5ml/2x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 4 | 3x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 5 | 2x5.5ml/2x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 6 | 1x5.5ml/3x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 7 | 4x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 8 | 2x5.5ml/3x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 9 | 1x5.5ml/4x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 10 | 5x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 11 | 2x5.5ml/4x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 12 | 1x5.5ml/5x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 13 | 6x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 14 | 2x5.5ml/5x8.1ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 15 | 1x5.5ml/6x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 16 | 7x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 17 | 2x5.5ml/6x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 18 | 1x5.5ml/7x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 19 | 8x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 20 | 2x5.5ml/7x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 21 | 1x5.5/8x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 22 | 9x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 23 | 2x5.5ml/8x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 24 | 1x5.5ml/9x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 25 | 10x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 26 | 2x5.5ml/9x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
| 27 | 1x5.5/10x8.3ml | Durchstechflasche(n) | M09AX09 | 01.99.0. | A |
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Other medicines from this authorisation holder
Frequently asked questions
Is ZOLGENSMA authorised in Switzerland?
Yes. ZOLGENSMA is authorised by Swissmedic under authorisation number 67529, data as of 01 September 2026. The authorisation is limited until 13 September 2028.
Which dispensing category does ZOLGENSMA have?
ZOLGENSMA 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 ZOLGENSMA?
The authorisation holder is Novartis Pharma Schweiz 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.