| Code | 9397D | ||||||||||
| MA number | 16/0003/22-S | ||||||||||
| Product Form: | sol inj 10x5 ml/500 mg (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 19.01.2022 |
| Validity: | 19.01.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| SPC: |
SPC_MEDSAMIC 100 mg_ml injekčný roztok_07.2025.pdf
|
| PIL: |
PIL_MEDSAMIC 100 mg_ml injekčný roztok_07.2025.pdf
|
| Safety feature | Yes |
| Data update: | 21.01.2022 |
