Ropivacain Sintetica 2 mg/ml
Ropivacain Sintetica 2 mg/ml is a medicine authorised by Swissmedic under authorisation number 60488. 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 14 June 2010 and the authorisation is valid without a time limit. ATC code N01BB09 places the medicine in the group Anesthetics.
| Authorisation number | 60488 |
|---|---|
| Name | Ropivacain Sintetica 2 mg/ml |
| Full name | Ropivacain Sintetica 2 mg/ml, soluzione iniettabile o per infusione |
| Authorisation holder | Sintetica SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | N01BB09 |
| First authorisation | 14 June 2010 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Ropivacain Sintetica 2 mg/ml, soluzione iniettabile o per infusione | B | 14 June 2010 |
| 2 | Ropivacain Sintetica 7.5 mg/ml, soluzione iniettabile | B | 14 June 2010 |
| 3 | Ropivacain Sintetica 10 mg/ml, soluzione iniettabile | B | 14 June 2010 |
| 4 | Ropivacain Sintetica 5 mg/ml, soluzione iniettabile | B | 25 April 2014 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 10 x 10 ml | Ampulle(n) | N01BB09 | 01.02.2. | B |
| 2 | 10 x 20 ml | Ampulle(n) | N01BB09 | 01.02.2. | B |
| 9 | 1 x 100 ml | Beutel | N01BB09 | 01.02.2. | B |
| 10 | 10 x 100 ml | Beutel | N01BB09 | 01.02.2. | B |
| 11 | 1 x 200 ml | Beutel | N01BB09 | 01.02.2. | B |
| 12 | 5 x 200 ml | Beutel | N01BB09 | 01.02.2. | B |
| 14 | 5 x 500 ml | Beutel | N01BB09 | 01.02.2. | B |
| 5 | 10 x 10 ml | Ampulle(n) | N01BB09 | 01.02.2. | B |
| 6 | 10 x 20 ml | Ampulle(n) | N01BB09 | 01.02.2. | B |
| 7 | 10 x 10 ml | Ampulle(n) | N01BB09 | 01.02.2. | B |
| 8 | 10 x 20 ml | Ampulle(n) | N01BB09 | 01.02.2. | B |
| 13 | 10 x 10 ml | Ampulle(n) | N01BB09 | 01.02.2. | B |
| 15 | 10 x 20 ml | Ampulle(n) | N01BB09 | 01.02.2. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Ropivacain Sintetica 2 mg/ml authorised in Switzerland?
Yes. Ropivacain Sintetica 2 mg/ml is authorised by Swissmedic under authorisation number 60488, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Ropivacain Sintetica 2 mg/ml have?
Ropivacain Sintetica 2 mg/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 Ropivacain Sintetica 2 mg/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.