Focalin XR 5 mg
Focalin XR 5 mg is a medicine authorised by Swissmedic under authorisation number 59245. The authorisation holder is Sandoz Pharmaceuticals AG. The medicinal product code is Synthetic medicines and the dispensing category is A+: Supplied only against a single-use prescription with additional Swissmedic conditions, for example narcotics or medicines with mandatory educational material. First authorisation was granted on 11 December 2009 and the authorisation is valid without a time limit. ATC code N06BA11 places the medicine in the group Psychoanaleptics.
| Authorisation number | 59245 |
|---|---|
| Name | Focalin XR 5 mg |
| Full name | Focalin XR 5 mg, Kapseln |
| Authorisation holder | Sandoz Pharmaceuticals AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A+ · Prescription with conditions |
| ATC code | N06BA11 |
| First authorisation | 11 December 2009 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Focalin XR 5 mg, Kapseln | A+ | 11 December 2009 |
| 2 | Focalin XR 10 mg, Kapseln | A+ | 11 December 2009 |
| 3 | Focalin XR 15 mg, Kapseln | A+ | 11 December 2009 |
| 4 | Focalin XR 20 mg, Kapseln | A+ | 11 December 2009 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | Kapsel(n) | N06BA11 | 01.10.2. | A+ |
| 2 | 100 | Kapsel(n) | N06BA11 | 01.10.2. | A+ |
| 3 | 30 | Kapsel(n) | N06BA11 | 01.10.2. | A+ |
| 4 | 100 | Kapsel(n) | N06BA11 | 01.10.2. | A+ |
| 5 | 30 | Kapsel(n) | N06BA11 | 01.10.2. | A+ |
| 6 | 100 | Kapsel(n) | N06BA11 | 01.10.2. | A+ |
| 7 | 30 | Kapsel(n) | N06BA11 | 01.10.2. | A+ |
| 8 | 100 | Kapsel(n) | N06BA11 | 01.10.2. | A+ |
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Other medicines from this authorisation holder
Frequently asked questions
Is Focalin XR 5 mg authorised in Switzerland?
Yes. Focalin XR 5 mg is authorised by Swissmedic under authorisation number 59245, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Focalin XR 5 mg have?
Focalin XR 5 mg is in dispensing category A+. Supplied only against a single-use prescription with additional Swissmedic conditions, for example narcotics or medicines with mandatory educational material.
Who is the authorisation holder of Focalin XR 5 mg?
The authorisation holder is Sandoz Pharmaceuticals 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.