| Code | 6071E | ||||||||||
| MA number | 16/0085/24-S | ||||||||||
| Product Form: | sol inf 50x50 ml/500 mg (fľ.PE (KabiPac)) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
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| Shelf life: | 30 | ||||||||||
| Container: | bottle PE | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 25.04.2024 |
| Validity: | 25.04.2029 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Tranexamic acid Kabi 10 mg_ml_04_2024.pdf
|
| SPC: |
SPC_Tranexamic acid Kabi 10 mg_ml_04_2024.pdf
|
| Safety feature | Yes |
| Data update: | 02.05.2024 |
