Kalydeco 75 mg film-coated tablets

{
  "form": "Film-coated tablet",
  "routes": [
    "Oral use"
  ],
  "source": "hpra",
  "atc_all": [
    "R07AX02"
  ],
  "strength": null,
  "pa_number": "EU/1/12/782/007",
  "substances": [
    "Ivacaftor"
  ],
  "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "25/11/2020",
  "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
}