Spedifen 400
Spedifen 400 is a medicine authorised by Swissmedic under authorisation number 50063. The authorisation holder is Zambon Svizzera SA. The medicinal product code is Synthetic 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 26 March 1990 and the authorisation is valid without a time limit. ATC code M01AE01 places the medicine in the group Anti-inflammatory and antirheumatic products.
| Authorisation number | 50063 |
|---|---|
| Name | Spedifen 400 |
| Full name | Spedifen 400, granulare |
| Authorisation holder | Zambon Svizzera SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | M01AE01 |
| First authorisation | 26 March 1990 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 2 | Spedifen 400, granulare | B | 26 March 1990 |
| 3 | Spedifen 600, granulare | B | 26 March 1990 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 46 | 30 | Sachet(s) | M01AE01 | 07.10.1. | B |
| 70 | 12 | Sachet(s) | M01AE01 | 07.10.1. | B |
| 54 | 30 | Sachet(s) | M01AE01 | 07.10.1. | B |
| 89 | 12 | Sachet(s) | M01AE01 | 07.10.1. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Spedifen 400 authorised in Switzerland?
Yes. Spedifen 400 is authorised by Swissmedic under authorisation number 50063, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Spedifen 400 have?
Spedifen 400 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 Spedifen 400?
The authorisation holder is Zambon Svizzera 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.