Zemcelpro = 0.23×106 viable CD34+ cells/mL/= 0.53×106 viable CD3+ cells/mL dispersion for infusion

{
  "form": "Dispersion for infusion",
  "routes": [
    "Intravenous use"
  ],
  "source": "hpra",
  "atc_all": [
    "B05AX04"
  ],
  "strength": null,
  "pa_number": "EU/1/25/1960/001",
  "substances": [
    "Haematopoietic stem cells and blood progenitor umbilical cord-derived expanded with (1R, 4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "25/08/2025",
  "dispensing_status": "Product subject to prescription which may not be renewed (A)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}