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 |
PIL: | PIL_Melphalan Zentiva 50 mg prášok a rozpúšťadlo na injekčný_infúzny roztok_05.2024.pdf |
SPC: | SPC_Melphalan Zentiva 50 mg prášok a rozpúšťadlo na injekčný_infúzny roztok_10.2024.pdf |
Safety feature | Yes |
Data update: | 21.10.2024 |