| Code | 2735E | ||||||||||
| MA number | 16/0027/23-S | ||||||||||
| Product Form: | tbl flm 60x1x2,5 mg (blis.PVC/PVDC/Al-perfor.-jednotliv.dáv.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | TEVA Pharmaceuticals Slovakia s.r.o., Slovakia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 25.01.2023 |
| Validity: | 25.01.2028 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Apixaban Teva Slovakia 2,5 mg_03.2024.pdf
|
| SPC: |
SPC_Apixaban Teva Slovakia 2,5 mg_07.2024.pdf
|
| Dokument: |
Karta pacienta_Apixaban Teva Slovakia_2,5 mg karta.pdf
|
| Dokument: |
Apixaban_Príručka pre lekára.pdf
|
| Safety feature | Yes |
| Data update: | 18.07.2024 |
