| Code | 1690D | ||||||||||
| MA number | 44/0177/19-S | ||||||||||
| Product Form: | plv iio 1x50 mg+1x10 ml solv. (liek.inj.skl+liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Zentiva k.s., Czechia | ||||||||||
| Therapeutic Class: | 44 - CYTOSTATICA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous and intraarterial use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 12.06.2019 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Melphalan Zentiva 50 mg prášok a rozpúšťadlo na injekčný_infúzny roztok_10.2024.pdf
|
| PIL: |
PIL_Melphalan Zentiva 50 mg prášok a rozpúšťadlo na injekčný_infúzny roztok_01.2025.pdf
|
| Safety feature | Yes |
| Data update: | 21.10.2024 |
