| Code | 2775A | ||||||||||
| MA number | 44/0418/12-S | ||||||||||
| Product Form: | con inf 5x1 ml/1 mg (liek.inj.skl.jantárová) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Accord Healthcare Polska Sp. z o.o., Poland | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | amber glass container | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 24.09.2012 |
| SPC: |
SPC_Topotecan Accord 1 mg_ml koncentrát na infúzny roztok_02.2024.pdf
|
| PIL: |
PIL_Topotecan Accord 1 mg_ml koncentrát na infúzny roztok_04.2025.pdf
|
| Safety feature | Yes |
| Data update: | 06.11.2023 |
