Code | 7704C | ||||||||||
MA number | EU/1/17/1261/001 | ||||||||||
Product Form: | sus inj 4x6 ml/30 miliónov buniek | ||||||||||
MA Status: | E - Valid centralised marketing authorisation | ||||||||||
Type of procedure: | EU Orphan | ||||||||||
MAH, country: | Takeda Pharma A/S, Denmark | ||||||||||
Therapeutic Class: | 59 - IMMUNOPRAEPARATA | ||||||||||
ATC: |
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Shelf life: | 72 hodín | ||||||||||
Container: | glass vial | ||||||||||
Route of admin.: | Intralesional use |
Prescription Status: | Medicinal product subject to restricted medical prescription. |
Legal basis: | Article 8(3) application - new active substance |
MA issued: | 23.03.2018 |
SmPC + PL: | European Medicines Agency's database |
Dokument: | Alofisel_Potenciálna mikrobiálna kontaminácia (Príručka pre zdravotníckych pracovníkov).pdf |
Dokument: | Alofisel_Spôsob podavania (Prirucka pre chirurgov).pdf |
Dokument: | Alofisel_Pokyny na príjem a uchovávanie lieku (Príručka pre lekárnikov).pdf |
Safety feature | No |
Data update: | 24.01.2023 |