Code | 7476E | ||||||||||
MA number | 16/0233/24-S | ||||||||||
Product Form: | tbl flm 10x1x15 mg (blis.PVC/PVDC/PVC//Al - jednotk.bal.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | TAD Pharma GmbH, Germany | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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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 |