| Code | 93650 | ||||||||||
| MA number | 16/0414/92-CS | ||||||||||
| Product Form: | plv iio 1x50 mg+1x50 ml solv. (liek.inj.skl.+liek.inj.skl.+1 prenosová kanyla) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | National | ||||||||||
| MAH, country: | Boehringer Ingelheim International GmbH, Germany | ||||||||||
| Therapeutic Class: | 16 - ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.) | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 01.07.1992 |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Actilyse 20 mg_50 mg_11.2024.pdf
|
| SPC: |
SPC_Actilyse 20 mg_50 mg_11.2024.pdf
|
| Safety feature | Yes |
| Data update: | 15.11.2024 |
