Denosumab Zentiva 60 mg
Denosumab Zentiva 60 mg is a medicine authorised by Swissmedic under authorisation number 70492. The authorisation holder is Helvepharm 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 06 February 2026 and the authorisation is limited until 05 February 2031. ATC code M05BX04 places the medicine in the group Drugs for treatment of bone diseases.
| Authorisation number | 70492 |
|---|---|
| Name | Denosumab Zentiva 60 mg |
| Full name | Denosumab Zentiva 60 mg, Injektionslösung (s.c.) |
| Authorisation holder | Helvepharm AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | M05BX04 |
| First authorisation | 06 February 2026 |
| Authorisation validity | 05 February 2031 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Denosumab Zentiva 60 mg, Injektionslösung (s.c.) | B | 06 February 2026 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Fertigspritze(n) | M05BX04 | 07.99.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Denosumab Zentiva 60 mg authorised in Switzerland?
Yes. Denosumab Zentiva 60 mg is authorised by Swissmedic under authorisation number 70492, data as of 01 September 2026. The authorisation is limited until 05 February 2031.
Which dispensing category does Denosumab Zentiva 60 mg have?
Denosumab Zentiva 60 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 Denosumab Zentiva 60 mg?
The authorisation holder is Helvepharm 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.