Rivoxin 400 mg filmom obložene tablete
| Name | Rivoxin 400 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-619049511 |
| Active Substance | moksifloksacinklorid |
| Composition | svaka filmom obložena tableta sadrži 400 mg moksifloksacina (u obliku moksifloksacinklorida) |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Laboratoires BTT, Erstein, Francuska |
| Marketing Authorisation Holder | Double-E Pharma Ltd., 17 Corrig Road, Sandyford, Irska |
| Marketing Authorisation Date | 11.06.2021 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 23.01.2025* |
| Classification Number | UP/I-530-09/21-02/46 |
| Registration Number | 381-12-01/70-21-03 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for non-renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J01MA14 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
*Note
Marketing authorisation has been revoked pursuant to Article 54, paragraph 1ili 2 of Medicinal Products Act (Official Gazette Nos. 76/13, 90/14 and 100/18) on account of the medicinal product not being placed on the market in the Republic of Croatia for three years from the date of the granting of a marketing authorisation.
