Baclofen Intrathecal Sintetica 10mg/5ml
Baclofen Intrathecal Sintetica 10mg/5ml is a medicine authorised by Swissmedic under authorisation number 56534. The authorisation holder is Sintetica 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 27 June 2007 and the authorisation is valid without a time limit. ATC code M03BX01 places the medicine in the group Muscle relaxants.
| Authorisation number | 56534 |
|---|---|
| Name | Baclofen Intrathecal Sintetica 10mg/5ml |
| Full name | Baclofen Intrathecal Sintetica 10mg/5ml, solution injectable |
| Authorisation holder | Sintetica SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | M03BX01 |
| First authorisation | 27 June 2007 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Baclofen Intrathecal Sintetica 10mg/5ml, solution injectable | B | 27 June 2007 |
| 2 | Baclofen Intrathecal Sintetica 10mg/20ml, solution injectable | B | 12 October 2011 |
| 3 | Baclofen Intrathecal Sintetica 0.05mg/1ml, solution injectable | B | 12 October 2011 |
Scroll the table sideways
| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 10 x 5 ml | Ampulle(n) | M03BX01 | 01.12.0. | B |
| 5 | 10 x 5 ml | Ampulle(n) | M03BX01 | 01.12.0. | B |
| 2 | 5 x 20 ml | Ampulle(n) | M03BX01 | 01.12.0. | B |
| 6 | 1 x 20 ml | Ampulle(n) | M03BX01 | 01.12.0. | B |
| 3 | 10 x 1ml | Ampulle(n) | M03BX01 | 01.12.0. | B |
Scroll the table sideways
Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Baclofen Intrathecal Sintetica 10mg/5ml authorised in Switzerland?
Yes. Baclofen Intrathecal Sintetica 10mg/5ml is authorised by Swissmedic under authorisation number 56534, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Baclofen Intrathecal Sintetica 10mg/5ml have?
Baclofen Intrathecal Sintetica 10mg/5ml 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 Baclofen Intrathecal Sintetica 10mg/5ml?
The authorisation holder is Sintetica 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.