Fabrazyme 35 mg
Fabrazyme 35 mg is a medicine authorised by Swissmedic under authorisation number 56261. The authorisation holder is Sanofi-Aventis (Suisse) SA. The medicinal product code is Biotechnological medicines 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 25 July 2003 and the authorisation is valid without a time limit. ATC code A16AB04 places the medicine in the group Other alimentary tract and metabolism products.
| Authorisation number | 56261 |
|---|---|
| Name | Fabrazyme 35 mg |
| Full name | Fabrazyme 35 mg, poudre pour solution à diluer pour perfusion |
| Authorisation holder | Sanofi-Aventis (Suisse) SA |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | A16AB04 |
| First authorisation | 25 July 2003 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Fabrazyme 35 mg, poudre pour solution à diluer pour perfusion | A | 25 July 2003 |
| 3 | Fabrazyme 5 mg, poudre pour solution à diluer pour perfusion | A | 01 September 2020 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 2 | 1 | Durchstechflasche(n) | A16AB04 | 07.14.0. | A |
| 3 | 1 | Durchstechflasche(n) | A16AB04 | 07.14.0. | A |
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Frequently asked questions
Is Fabrazyme 35 mg authorised in Switzerland?
Yes. Fabrazyme 35 mg is authorised by Swissmedic under authorisation number 56261, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Fabrazyme 35 mg have?
Fabrazyme 35 mg 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 Fabrazyme 35 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.