Code | 5404E | ||||||||||
MA number | 16/0019/24-S | ||||||||||
Product Form: | tbl flm 42x15 mg (blis.PVC/PE/PVdC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
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: | 15.02.2024 |
Validity: | 15.02.2029 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
Dokument: |
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SPC: |
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PIL: |
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Safety feature | Yes |
Data update: | 21.02.2024 |