Temelor 0,5 mg tablete
| Name | Temelor 0,5 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-785933953 |
| Active Substance | lorazepam |
| Composition | svaka tableta sadrži 0,5 mg lorazepama |
| Pharmaceutical Form | Tableta |
| Manufacturer | Medochemie Ltd., Agios Athanassios, Limassol, Cipar Farmaceutisch Analytisch Laboratorium Duiver B.V. (FAL B.V.), Duiven, Gelderland, Nizozemska |
| Marketing Authorisation Holder | Medochemie Ltd., Constatinoupoleos Str. 1-10, Limassol, Cipar |
| Marketing Authorisation Date | 07.02.2022 |
| MA Period of Validity | 07.02.2027 |
| MA Revocation Date | 11.09.2026* |
| Classification Number | UP/I-530-09/21-01/160 |
| Registration Number | 381-12-01/70-22-05 |
| 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 | N05BA06 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act, only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
