Orylmyte 300 IR sublingvalne tablete
| Name | Orylmyte 300 IR sublingvalne tablete |
|---|---|
| Marketing Authorisation Number | HR-H-696635390 |
| Active Substance | standardiziran ekstrakt alergena grinja kućne prašine Dermatophagoides pteronyssinus standardiziran ekstrakt alergena grinja kućne prašine Dermatophagoides farinae |
| Composition | jedna sublingvalna tableta sadrži 300 IR standardiziranog alergenog ekstrakta grinja kućne prašine Dermatophagoides pteronyssinus i Dermatophagoides farinae |
| Pharmaceutical Form | sublingvalna tableta |
| Manufacturer | Stallergenes, Antony, Francuska |
| Marketing Authorisation Holder | Stallergenes, 6 rue Alexis de Tocqueville, Antony, Francuska |
| Marketing Authorisation Date | 03.11.2025 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/25-02/156 |
| Registration Number | 381-12-01/171-25-04 |
| 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 | V01AA03 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
