| Code | 8064E | ||||||||||
| MA number | 16/0309/24-S | ||||||||||
| Product Form: | tbl flm 60x60 mg (blis.OPA/Al/PVC//Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister OPA/Al/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.11.2024 |
| Validity: | 28.11.2029 |
| SPC: |
SPC_Delianda_tbl flm_11_2024.pdf
|
| PIL: |
PIL_Delianda_tbl flm_11_2024.pdf
|
| Safety feature | Yes |
| Data update: | 02.12.2024 |
