| Code | 7484E | ||||||||||
| MA number | 16/0233/24-S | ||||||||||
| Product Form: | tbl flm 56x15 mg (blis.PVC/PVDC/PVC//Al - kalend.bal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | TAD Pharma GmbH, Germany | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 20.09.2024 |
| Validity: | 20.09.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Razarxo 15 mg; 20 mg filmom obalené tablety_09_2024.pdf
|
| SPC: |
SPC_Razarxo 15 mg filmom obalené tablety_09_2024.pdf
|
| Safety feature | Yes |
| Data update: | 23.09.2024 |
