Dormicum 5 mg/1 mL
Dormicum 5 mg/1 mL is a medicine authorised by Swissmedic under authorisation number 44448. The authorisation holder is Cheplapharm Schweiz GmbH. 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 10 September 1982 and the authorisation is valid without a time limit. ATC code N05CD08 places the medicine in the group Psycholeptics.
| Authorisation number | 44448 |
|---|---|
| Name | Dormicum 5 mg/1 mL |
| Full name | Dormicum 5 mg/1 mL, Injektionslösung |
| Authorisation holder | Cheplapharm Schweiz GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N05CD08 |
| First authorisation | 10 September 1982 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Dormicum 5 mg/1 mL, Injektionslösung | B | 10 September 1982 |
| 2 | Dormicum 5 mg/5 mL, Injektionslösung | B | 18 July 1988 |
| 3 | Dormicum 50 mg/10 mL, Injektionslösung | B | 15 May 1991 |
| 4 | Dormicum 15 mg/3 mL, Injektionslösung | B | 02 October 1998 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 25 | 10 x 1 | ml | N05CD08 | 01.03.1. | B |
| 33 | 10 x 5 | ml | N05CD08 | 01.03.1. | B |
| 41 | 5 x 10 | ml | N05CD08 | 01.03.1. | B |
| 68 | 5 x 3 | ml | N05CD08 | 01.03.1. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Dormicum 5 mg/1 mL authorised in Switzerland?
Yes. Dormicum 5 mg/1 mL is authorised by Swissmedic under authorisation number 44448, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Dormicum 5 mg/1 mL have?
Dormicum 5 mg/1 mL 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 Dormicum 5 mg/1 mL?
The authorisation holder is Cheplapharm Schweiz GmbH. 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.