| Code | 2974E | ||||||||||
| MA number | 16/0052/23-S | ||||||||||
| Product Form: | cps dur 10x1x150 mg (blis.Al/Al-perfor.jednodávk.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Gedeon Richter Plc., Hungary | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | blister Al/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 08.03.2023 |
| Validity: | 08.03.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_TELEXER 150 mg tvrdé kapsuly_03.2024.pdf
|
| PIL: |
PIL_TELEXER 150 mg tvrdé kapsuly_03.2024.pdf
|
| 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
|
| Safety feature | Yes |
| Data update: | 13.03.2023 |
