Singulair 5 mg
Singulair 5 mg is a medicine authorised by Swissmedic under authorisation number 54391. The authorisation holder is Organon 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 29 June 1998 and the authorisation is valid without a time limit. ATC code R03DC03 places the medicine in the group Drugs for obstructive airway diseases.
| Authorisation number | 54391 |
|---|---|
| Name | Singulair 5 mg |
| Full name | Singulair 5 mg, Kautabletten für Kinder |
| Authorisation holder | Organon GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | R03DC03 |
| First authorisation | 29 June 1998 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Singulair 5 mg, Kautabletten für Kinder | B | 29 June 1998 |
| 2 | Singulair 4 mg, Kautabletten für Kleinkinder | B | 26 March 2001 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 13 | 28 | Tablette(n) | R03DC03 | 03.04.5. | B |
| 21 | 98 | Tablette(n) | R03DC03 | 03.04.5. | B |
| 48 | 28 | Tablette(n) | R03DC03 | 03.04.5. | B |
| 56 | 98 | Tablette(n) | R03DC03 | 03.04.5. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Singulair 5 mg authorised in Switzerland?
Yes. Singulair 5 mg is authorised by Swissmedic under authorisation number 54391, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Singulair 5 mg have?
Singulair 5 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 Singulair 5 mg?
The authorisation holder is Organon 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.