Temelor 1 mg tablete
| Name | Temelor 1 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-956450782 |
| Active Substance | lorazepam |
| Composition | svaka tableta sadrži 1 mg lorazepama |
| Pharmaceutical Form | Tableta |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru, u kutiji [HR-H-956450782-01] 14 tableta u blisteru, u kutiji [HR-H-956450782-02] 15 tableta u blisteru, u kutiji [HR-H-956450782-03] 20 tableta u blisteru, u kutiji [HR-H-956450782-04] 28 tableta u blisteru, u kutiji [HR-H-956450782-05] 30 tableta u blisteru, u kutiji [HR-H-956450782-06] 50 tableta u blisteru, u kutiji [HR-H-956450782-07] 60 tableta u blisteru, u kutiji [HR-H-956450782-08] 90 tableta u blisteru, u kutiji [HR-H-956450782-09] 100 tableta u blisteru, u kutiji [HR-H-956450782-10] 500 tableta u blisteru, u kutiji [HR-H-956450782-11] |
| 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 |
| Classification Number | UP/I-530-09/21-01/161 |
| Registration Number | 381-12-01/70-22-03 |
| Prescription | na recept |
| Type of prescription | neponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N05BA06 |
| Medicinal product marketed in the Croatia | Nestašica |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
