| Code | 5668E | ||||||||||
| MA number | 78/0045/24-S | ||||||||||
| Product Form: | cps dur 100x60 mg (fľ.HDPE+SecuRx uzáver) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 78 - SYMPATHOMIMETICA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 03.04.2024 |
| Validity: | 03.04.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| Dokument: |
Livizux_Schéma_priebežného_monitorovania_liečby.pdf
|
| Dokument: |
Livizux_Kontrolny_zoznam_2_Priebežné monitorovanie liečby.pdf
|
| Dokument: |
Livizux_Príručka_pre_pacientov a ich opatrovateľov.pdf
|
| Dokument: |
Livizux_Kontrolný_zoznam_1_Pred predpísaním lieku.pdf
|
| PIL: |
PIL_Livizux_03.2025.pdf
|
| SPC: |
SPC_Livizux_03.2025.pdf
|
| Safety feature | Yes |
| Data update: | 03.04.2024 |
