Naglazyme
Naglazyme is a medicine authorised by Swissmedic under authorisation number 58224. The authorisation holder is DRAC AG. 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 02 October 2007 and the authorisation is valid without a time limit. ATC code A16AB08 places the medicine in the group Other alimentary tract and metabolism products.
| Authorisation number | 58224 |
|---|---|
| Name | Naglazyme |
| Full name | Naglazyme, Konzentrat zur Herstellung einer Infusionslösung |
| Authorisation holder | DRAC AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | A16AB08 |
| First authorisation | 02 October 2007 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Naglazyme, Konzentrat zur Herstellung einer Infusionslösung | B | 02 October 2007 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 x 5 ml | Durchstechflasche(n) | A16AB08 | 07.14.0. | B |
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Other medicines from this authorisation holder
Frequently asked questions
Is Naglazyme authorised in Switzerland?
Yes. Naglazyme is authorised by Swissmedic under authorisation number 58224, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Naglazyme have?
Naglazyme 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 Naglazyme?
The authorisation holder is DRAC 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.