Lerin 5 mg implantat
| Name | Lerin 5 mg implantat |
|---|---|
| Former Name | Leuprone 5 mg implantat |
| Marketing Authorisation Number | HR-H-468174689 |
| Active Substance | leuprorelinacetat |
| Composition | 1 implantat sadrži 5 mg leuprorelina (u obliku acetata) |
| Pharmaceutical Form | implantat |
| Manufacturer | Sandoz GmbH, Kundl, Austrija Ever Pharma Jena GmbH, Jena, Njemačka Ever Pharma Jena GmbH, Jena, Njemačka Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 13.10.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/498 |
| Registration Number | 381-12-01/30-17-05 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L02AE02 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o potrebi strožeg pridržavanja uputa za rekonstituciju i primjenu lijekova koji sadrže depo formulacije leuprorelina kako ne bi došlo do izostanka njihove učinkovitosti | 30.07.2020 | Astellas d.o.o., Sandoz d.o.o., PharmaS d.o.o. |
