Fentanyl Sintetica 0.05 mg/1 ml
Fentanyl Sintetica 0.05 mg/1 ml is a medicine authorised by Swissmedic under authorisation number 53987. The authorisation holder is Sintetica SA. 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 14 February 1997 and the authorisation is valid without a time limit. ATC code N01AH01 places the medicine in the group Anesthetics.
| Authorisation number | 53987 |
|---|---|
| Name | Fentanyl Sintetica 0.05 mg/1 ml |
| Full name | Fentanyl Sintetica 0.05 mg/1 ml, soluzione iniettabile |
| Authorisation holder | Sintetica SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A+ · Prescription with conditions |
| ATC code | N01AH01 |
| First authorisation | 14 February 1997 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Fentanyl Sintetica 0.05 mg/1 ml, soluzione iniettabile | A+ | 14 February 1997 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 10 x 2 ml | Ampulle(n) | N01AH01 | 01.01.3. | A+ |
| 2 | 10 x 10 ml | Ampulle(n) | N01AH01 | 01.01.3. | A+ |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Fentanyl Sintetica 0.05 mg/1 ml authorised in Switzerland?
Yes. Fentanyl Sintetica 0.05 mg/1 ml is authorised by Swissmedic under authorisation number 53987, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Fentanyl Sintetica 0.05 mg/1 ml have?
Fentanyl Sintetica 0.05 mg/1 ml 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 Fentanyl Sintetica 0.05 mg/1 ml?
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.