Code | 5588E | ||||||||||
MA number | 16/0036/24-S | ||||||||||
Product Form: | cps dur 60x150 mg (fľ.HDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | KRKA, d.d., Novo mesto, Slovenia | ||||||||||
Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
ATC: |
|
||||||||||
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: | 23.02.2024 |
Validity: | 23.02.2029 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Daxanlo 150 mg_02.2024.pdf |
SPC: | SPC_Daxanlo 150 mg_02.2024.pdf |
Dokument: | dabigatran etexilát_Príručka pre predpisujúceho lekára VTE.pdf |
Dokument: | dabigatran etexilát_Príručka pre predpisujúceho lekára CMP.pdf |
Dokument: | dabigatran etexilát_Príručka pre predpisujúceho lekára - pediatria.pdf |
Safety feature | Yes |
Data update: | 01.03.2024 |