{
  "description": "EU EPI SmPC QRD code values",
  "_filename": "CodeSystem-300000000001.json",
  "package_name": "eu.epi.february2025",
  "date": null,
  "publisher": "European Medicines Agency",
  "jurisdiction": [ {
    "text": "European Union"
  } ],
  "content": "complete",
  "name": "EUepismpccodesystem",
  "type": null,
  "experimental": "false",
  "resourceType": "CodeSystem",
  "title": "EU EPI SmPC QRD code values",
  "package_version": "1.0.0",
  "status": "active",
  "id": "741e173f-e8b4-42c2-a793-d29fa239a482",
  "kind": null,
  "count": 62,
  "url": "http://ema.europa.eu/fhir/CodeSystem/300000000001",
  "concept": [ {
    "code": "000000000000",
    "display": "Code for custom sub-sections (reserved)"
  }, {
    "code": "000000000004",
    "display": "Code for custom sub-sections (level 4)"
  }, {
    "code": "000000000005",
    "display": "Code for custom sub-sections (level 5)"
  }, {
    "code": "200000029791",
    "display": "SUMMARY OF PRODUCT CHARACTERISTICS"
  }, {
    "code": "200000029792",
    "display": "1. NAME OF THE MEDICINAL PRODUCT"
  }, {
    "code": "200000029793",
    "display": "2. QUALITATIVE AND QUANTITATIVE COMPOSITION"
  }, {
    "code": "200000029794",
    "display": "2.1 General description"
  }, {
    "code": "200000029795",
    "display": "2.2 Qualitative and quantitative composition"
  }, {
    "code": "200000029796",
    "display": "Excipient(s) with known effect"
  }, {
    "code": "200000029797",
    "display": "3. PHARMACEUTICAL FORM"
  }, {
    "code": "200000029798",
    "display": "4. CLINICAL PARTICULARS"
  }, {
    "code": "200000029799",
    "display": "4.1 Therapeutic indications"
  }, {
    "code": "200000029800",
    "display": "4.2 Posology and method of administration"
  }, {
    "code": "200000029801",
    "display": "Posology"
  }, {
    "code": "200000029802",
    "display": "Paediatric population"
  }, {
    "code": "200000029803",
    "display": "Method of administration"
  }, {
    "code": "200000029804",
    "display": "Precautions to be taken before handling or administering the medicinal product"
  }, {
    "code": "200000029805",
    "display": "4.3 Contraindications"
  }, {
    "code": "200000029806",
    "display": "4.4 Special warnings and precautions for use"
  }, {
    "code": "200000029807",
    "display": "Traceability"
  }, {
    "code": "200000029808",
    "display": "Paediatric population"
  }, {
    "code": "200000029809",
    "display": "4.5 Interaction with other medicinal products and other forms of interaction"
  }, {
    "code": "200000029810",
    "display": "Paediatric population"
  }, {
    "code": "200000029811",
    "display": "4.6 Fertility, pregnancy and lactation"
  }, {
    "code": "200000029812",
    "display": "Pregnancy"
  }, {
    "code": "200000029813",
    "display": "Breast-feeding"
  }, {
    "code": "200000029814",
    "display": "Fertility"
  }, {
    "code": "200000029815",
    "display": "4.7 Effects on ability to drive and use machines"
  }, {
    "code": "200000029816",
    "display": "4.8 Undesirable effects"
  }, {
    "code": "200000029817",
    "display": "Paediatric population"
  }, {
    "code": "200000029818",
    "display": "Reporting of suspected adverse reactions"
  }, {
    "code": "200000029819",
    "display": "4.9 Overdose"
  }, {
    "code": "200000029820",
    "display": "Paediatric population"
  }, {
    "code": "200000029821",
    "display": "5. PHARMACOLOGICAL PROPERTIES"
  }, {
    "code": "200000029822",
    "display": "5.1 Pharmacodynamic properties"
  }, {
    "code": "200000029823",
    "display": "Mechanism of action"
  }, {
    "code": "200000029824",
    "display": "Pharmacodynamic effects"
  }, {
    "code": "200000029825",
    "display": "Clinical efficacy and safety"
  }, {
    "code": "200000029826",
    "display": "Paediatric population"
  }, {
    "code": "200000029827",
    "display": "5.2 Pharmacokinetic properties"
  }, {
    "code": "200000029828",
    "display": "Absorption"
  }, {
    "code": "200000029829",
    "display": "Distribution"
  }, {
    "code": "200000029830",
    "display": "Biotransformation"
  }, {
    "code": "200000029831",
    "display": "Elimination"
  }, {
    "code": "200000029832",
    "display": "Linearity/non-linearity"
  }, {
    "code": "200000029833",
    "display": "Pharmacokinetic/pharmacodynamic relationship(s)"
  }, {
    "code": "200000029834",
    "display": "5.3 Preclinical safety data"
  }, {
    "code": "200000029835",
    "display": "Environmental risk assessment (ERA)"
  }, {
    "code": "200000029836",
    "display": "6. PHARMACEUTICAL PARTICULARS"
  }, {
    "code": "200000029837",
    "display": "6.1 List of excipients"
  }, {
    "code": "200000029838",
    "display": "6.2 Incompatibilities"
  }, {
    "code": "200000029839",
    "display": "6.3 Shelf life"
  }, {
    "code": "200000029840",
    "display": "6.4 Special precautions for storage"
  }, {
    "code": "200000029841",
    "display": "6.5 Nature and contents of container , administration or implantation>"
  }, {
    "code": "200000029842",
    "display": "6.6 Special precautions for disposal "
  }, {
    "code": "200000029843",
    "display": "Use in the paediatric population"
  }, {
    "code": "200000029844",
    "display": "7. MARKETING AUTHORISATION HOLDER"
  }, {
    "code": "200000029845",
    "display": "8. MARKETING AUTHORISATION NUMBER(S)"
  }, {
    "code": "200000029846",
    "display": "9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"
  }, {
    "code": "200000029847",
    "display": "10. DATE OF REVISION OF THE TEXT"
  }, {
    "code": "200000029848",
    "display": "11. DOSIMETRY"
  }, {
    "code": "200000029849",
    "display": "12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS"
  } ],
  "caseSensitive": true,
  "version": "5.0.0"
}