Stalevo 50/12.5/200 mg
Stalevo 50/12.5/200 mg is a medicine authorised by Swissmedic under authorisation number 56676. The authorisation holder is Orion Pharma AG. 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 04 March 2004 and the authorisation is valid without a time limit. ATC code N04BA03 places the medicine in the group Anti-Parkinson drugs.
| Authorisation number | 56676 |
|---|---|
| Name | Stalevo 50/12.5/200 mg |
| Full name | Stalevo 50/12.5/200 mg, Filmtabletten |
| Authorisation holder | Orion Pharma AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N04BA03 |
| First authorisation | 04 March 2004 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Stalevo 50/12.5/200 mg, Filmtabletten | B | 04 March 2004 |
| 2 | Stalevo 100/25/200 mg, Filmtabletten | B | 04 March 2004 |
| 3 | Stalevo 150/37.5/200 mg, Filmtabletten | B | 04 March 2004 |
| 4 | Stalevo 200/50/200 mg, Filmtabletten | B | 08 June 2009 |
| 5 | Stalevo 75/18.75/200 mg, Filmtabletten | B | 12 January 2010 |
| 6 | Stalevo 125/31.25/200 mg, Filmtabletten | B | 12 January 2010 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 3 | 30 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 5 | 100 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 11 | 30 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 13 | 100 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 19 | 30 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 21 | 100 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 22 | 30 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 23 | 100 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 24 | 30 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 25 | 100 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 26 | 30 | Tablette(n) | N04BA03 | 01.08.0. | B |
| 27 | 100 | Tablette(n) | N04BA03 | 01.08.0. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Stalevo 50/12.5/200 mg authorised in Switzerland?
Yes. Stalevo 50/12.5/200 mg is authorised by Swissmedic under authorisation number 56676, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Stalevo 50/12.5/200 mg have?
Stalevo 50/12.5/200 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 Stalevo 50/12.5/200 mg?
The authorisation holder is Orion Pharma 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.