Code | 8346E | ||||||||||
MA number | 16/0337/24-S | ||||||||||
Product Form: | tbl flm 14x5 mg (blis.Al-PVC/PVdC) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
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Shelf life: | 36 | ||||||||||
Container: | blister Al/PVC/PVDC | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 03.01.2025 |
Validity: | 03.01.2030 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: |
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PIL: |
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Safety feature | Yes |
Data update: | 07.01.2025 |