| 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: |
|
||||||||||
| 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 |
