Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml otopina za injekciju
| Name | Mydrane 0,2 mg/ml + 3,1 mg/ml + 10 mg/ml otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-561244487 |
| Active Substance | tropikamid fenilefrinklorid lidokainklorid hidrat |
| Composition | 1 ml otopine za injekciju sadrži 0,2 mg tropikamida, 3,1 mg fenilefrinklorida i 10 mg lidokainklorid hidrata |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | Delpharm Tours, Chambray les Tours, Francuska Laboratoires Thea, Clermont-Ferrand - Cedex 2, Francuska |
| Marketing Authorisation Holder | Laboratoires Thea, 12 rue Louis Bleriot, Clermont-Ferrand - Cedex 2, Francuska |
| Marketing Authorisation Date | 14.10.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/201 |
| Registration Number | 381-12-01/70-20-03 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | S01FA56 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
