Code | 6830E | ||||||||||
MA number | 16/0170/24-S | ||||||||||
Product Form: | cps dur 30x150 mg (blis. OPA/Al/vysúšadlo PE-Al/PE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | STADA Arzneimittel AG, Germany | ||||||||||
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: | 06.08.2024 |
Validity: | 06.08.2029 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Dabigatran etexilate STADA 150 mg tvrdé kapsuly_07 2024.pdf |
PIL: | PIL_Dabigatran etexilate STADA 150 mg tvrdé kapsuly_07 2024.pdf |
Safety feature | Yes |
Data update: | 23.08.2024 |