Dexmedetomidin Labatec 200 μg/2 ml
Dexmedetomidin Labatec 200 μg/2 ml is a medicine authorised by Swissmedic under authorisation number 69348. The authorisation holder is Labatec Pharma SA. The medicinal product code is Synthetic medicines and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 11 January 2024 and the authorisation is limited until 10 January 2029. ATC code N05CM18 places the medicine in the group Psycholeptics.
| Authorisation number | 69348 |
|---|---|
| Name | Dexmedetomidin Labatec 200 μg/2 ml |
| Full name | Dexmedetomidin Labatec 200 μg/2 ml, solution à diluer pour perfusion |
| Authorisation holder | Labatec Pharma SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | N05CM18 |
| First authorisation | 11 January 2024 |
| Authorisation validity | 10 January 2029 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Dexmedetomidin Labatec 200 μg/2 ml, solution à diluer pour perfusion | A | 11 January 2024 |
| 2 | Dexmedetomidin Labatec 400 μg/4 ml, solution à diluer pour perfusion | A | 11 January 2024 |
| 3 | Dexmedetomidin Labatec 1000 μg/10 ml, solution à diluer pour perfusion | A | 11 January 2024 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 5 | Ampulle(n) | N05CM18 | 01.04.1. | A |
| 2 | 5 | Ampulle(n) | N05CM18 | 01.04.1. | A |
| 3 | 5 | Ampulle(n) | N05CM18 | 01.04.1. | A |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Dexmedetomidin Labatec 200 μg/2 ml authorised in Switzerland?
Yes. Dexmedetomidin Labatec 200 μg/2 ml is authorised by Swissmedic under authorisation number 69348, data as of 01 September 2026. The authorisation is limited until 10 January 2029.
Which dispensing category does Dexmedetomidin Labatec 200 μg/2 ml have?
Dexmedetomidin Labatec 200 μg/2 ml is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.
Who is the authorisation holder of Dexmedetomidin Labatec 200 μg/2 ml?
The authorisation holder is Labatec Pharma 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.