| Code | 3976E | ||||||||||
| MA number | 16/0162/23-S | ||||||||||
| Product Form: | tbl flm 30x20 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 12.07.2023 |
| Validity: | 12.07.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Enkia_10.2024.pdf
|
| PIL: |
PIL_Enkia_10.2024.pdf
|
| Dokument: |
Príručka pre lekára_rivaroxabán_V3.pdf
|
| Dokument: |
ENKIA_Karta pacienta.pdf
|
| Safety feature | Unknown |
| Data update: | 21.07.2023 |
