Bupivacain Sintetica 2
Bupivacain Sintetica 2 is a medicine authorised by Swissmedic under authorisation number 48351. 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 09 May 1988 and the authorisation is valid without a time limit. ATC code N01BB01 places the medicine in the group Anesthetics.
| Authorisation number | 48351 |
|---|---|
| Name | Bupivacain Sintetica 2 |
| Full name | Bupivacain Sintetica 2,5 mg/ml, soluzione iniettabile |
| Authorisation holder | Sintetica SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N01BB01 |
| First authorisation | 09 May 1988 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Bupivacain Sintetica 2,5 mg/ml, soluzione iniettabile | B | 09 May 1988 |
| 2 | Bupivacain Sintetica 5 mg/ml ampoule, soluzione iniettabile | B | 09 May 1988 |
| 5 | Bupivacain Sintetica 40 mg/ml, concentrato per soluzione iniettabile | B | 29 May 2009 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 3 | 10 x 5 ml | Ampulle(n) | N01BB01 | 01.02.2. | B |
| 18 | 10 x 5 ml | Ampulle(n) | N01BB01 | 01.02.2. | B |
| 50 | 5 x 20 ml | Ampulle(n) | N01BB01 | 01.02.2. | B |
| 1 | 10 x 5 ml | Ampulle(n) | N01BB01 | 01.02.2. | B |
| 2 | 5 x 20 ml | Ampulle(n) | N01BB01 | 01.02.2. | B |
| 4 | 10 x 5 ml | Ampulle(n) | N01BB01 | 01.02.2. | B |
| 7 | 10 x 5 ml | Ampulle(n) | N01BB01 | 01.02.2. | B |
| 86 | 10 x 5 ml | Ampulle(n) | N01BB01 | 01.02.2. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Bupivacain Sintetica 2 authorised in Switzerland?
Yes. Bupivacain Sintetica 2 is authorised by Swissmedic under authorisation number 48351, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Bupivacain Sintetica 2 have?
Bupivacain Sintetica 2 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 Bupivacain Sintetica 2?
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.