| Code | 5537E | ||||||||||
| MA number | 16/0024/24-S | ||||||||||
| Product Form: | cps dur 100(2x50)x1x110 mg (blis.Al/Al + vysúšadlo) - jednotk.bal. - multibal. | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Glenmark Pharmaceuticals s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 20.02.2024 |
| Validity: | 20.02.2029 |
| MA renewed: | Renewal application submitted |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| Dokument: |
dabigatran-etexilát_Príručka pre predpisujúceho lekára_ VTE.pdf
|
| Dokument: |
dabigatran-etexilát_Príručka pre predpisujúceho lekára_CMP.pdf
|
| Dokument: |
dabigatran-etexilát_Priručka pre predpisujúceho lekára_ pediatria.pdf
|
| PIL: |
PIL_Dabigatran etexilate Glenmark 110 mg_07.2025.pdf
|
| SPC: |
SPC_Dabigatran etexilate Glenmark 110 mg_07.2025.pdf
|
| Safety feature | Yes |
| Data update: | 24.07.2025 |
