| Code | 0514E | ||||||||||
| MA number | 17/0100/22-S | ||||||||||
| Product Form: | ins itu 1x20µg/24 hodín (blis.PETG) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Gedeon Richter Plc., Hungary | ||||||||||
| Therapeutic Class: | 17 - ANTICONCIPIENTIA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 60 | ||||||||||
| Container: | blister PETG | ||||||||||
| Route of admin.: | Intrauterine use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 02.05.2022 |
| Validity: | 02.05.2027 |
| MA renewed: | Renewal application submitted |
| Pediatric posology: | Yes |
| PIL: |
PIL_Levosert_SHI_03_2024.pdf
|
| SPC: |
SPC_Levosert_SHI_03_2024.pdf
|
| Dokument: |
Levosert SHI_Karta pacienta.pdf
|
| Dokument: |
Levosert a Levosert SHI_Kombinovana edukacna prirucka pre zdravotnickych pracovnikov.pdf
|
| Safety feature | Yes |
| Data update: | 06.05.2022 |
