PackagesCanonicalsLogsProblems
    Packages
    eu.epi.february2025@1.0.0
    http://ema.europa.eu/fhir/CodeSystem/300000000006
{
  "description": "EU EPI NAP-MRP-DCP QRD code values",
  "_filename": "CodeSystem-300000000006.json",
  "package_name": "eu.epi.february2025",
  "date": null,
  "publisher": "European Medicines Agency",
  "jurisdiction": [ {
    "text": "European Union"
  } ],
  "content": "complete",
  "name": "EUepinapmrpdcpcodesystem",
  "type": null,
  "experimental": "false",
  "resourceType": "CodeSystem",
  "title": "EU EPI NAP-MRP-DCP QRD code values",
  "package_version": "1.0.0",
  "status": "active",
  "id": "b3f62747-6b44-4de0-998e-c4e8ff2dcd71",
  "kind": null,
  "count": 122,
  "url": "http://ema.europa.eu/fhir/CodeSystem/300000000006",
  "concept": [ {
    "code": "000000000000",
    "display": "Code for custom sub-sections (reserved)"
  }, {
    "code": "000000000003",
    "display": "Code for custom sub-sections (level 3)"
  }, {
    "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": "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"
  }, {
    "code": "200000029861",
    "display": "LABELLING"
  }, {
    "code": "200000029862",
    "display": "PARTICULARS TO APPEAR ON    {NATURE/TYPE}"
  }, {
    "code": "200000029863",
    "display": "1. NAME OF THE MEDICINAL PRODUCT"
  }, {
    "code": "200000029864",
    "display": "2. STATEMENT OF ACTIVE SUBSTANCE(S)"
  }, {
    "code": "200000029865",
    "display": "3. LIST OF EXCIPIENTS"
  }, {
    "code": "200000029866",
    "display": "4. PHARMACEUTICAL FORM AND CONTENTS"
  }, {
    "code": "200000029867",
    "display": "5. METHOD AND ROUTE(S) OF ADMINISTRATION"
  }, {
    "code": "200000029868",
    "display": "6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN"
  }, {
    "code": "200000029869",
    "display": "7. OTHER SPECIAL WARNING(S), IF NECESSARY"
  }, {
    "code": "200000029870",
    "display": "8. EXPIRY DATE"
  }, {
    "code": "200000029871",
    "display": "9. SPECIAL STORAGE CONDITIONS"
  }, {
    "code": "200000029872",
    "display": "10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE"
  }, {
    "code": "200000029873",
    "display": "11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER"
  }, {
    "code": "200000029874",
    "display": "12. MARKETING AUTHORISATION NUMBER(S)"
  }, {
    "code": "200000029875",
    "display": "13. BATCH NUMBER<, DONATION AND PRODUCT CODES>"
  }, {
    "code": "200000029876",
    "display": "14. GENERAL CLASSIFICATION FOR SUPPLY"
  }, {
    "code": "200000029877",
    "display": "15. INSTRUCTIONS ON USE"
  }, {
    "code": "200000029878",
    "display": "16. INFORMATION IN BRAILLE"
  }, {
    "code": "200000029879",
    "display": "17. UNIQUE IDENTIFIER - 2D BARCODE"
  }, {
    "code": "200000029880",
    "display": "18. UNIQUE IDENTIFIER - HUMAN READABLE DATA"
  }, {
    "code": "200000029881",
    "display": "MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}"
  }, {
    "code": "200000029882",
    "display": "1. NAME OF THE MEDICINAL PRODUCT"
  }, {
    "code": "200000029883",
    "display": "2. NAME OF THE MARKETING AUTHORISATION HOLDER"
  }, {
    "code": "200000029884",
    "display": "3. EXPIRY DATE"
  }, {
    "code": "200000029885",
    "display": "4. BATCH NUMBER<, DONATION AND PRODUCT CODES>"
  }, {
    "code": "200000029886",
    "display": "5. OTHER"
  }, {
    "code": "200000029887",
    "display": "MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}"
  }, {
    "code": "200000029888",
    "display": "1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION"
  }, {
    "code": "200000029889",
    "display": "2. METHOD OF ADMINISTRATION"
  }, {
    "code": "200000029890",
    "display": "3. EXPIRY DATE"
  }, {
    "code": "200000029891",
    "display": "4. BATCH NUMBER<, DONATION AND PRODUCT CODES>"
  }, {
    "code": "200000029892",
    "display": "5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT"
  }, {
    "code": "200000029893",
    "display": "6. OTHER"
  }, {
    "code": "200000029894",
    "display": "PACKAGE LEAFLET"
  }, {
    "code": "200000029895",
    "display": "1. What X is and what it is used for"
  }, {
    "code": "200000029896",
    "display": "2. What you need to know before you   X"
  }, {
    "code": "200000029897",
    "display": "Do not   X"
  }, {
    "code": "200000029898",
    "display": "Warnings and precautions"
  }, {
    "code": "200000029899",
    "display": "Children "
  }, {
    "code": "200000029900",
    "display": "Other medicines and X"
  }, {
    "code": "200000029901",
    "display": "X with   <,>   "
  }, {
    "code": "200000029902",
    "display": "Pregnancy  <,> breast-feeding "
  }, {
    "code": "200000029903",
    "display": "Driving and using machines"
  }, {
    "code": "200000029904",
    "display": "X contains {name the excipient(s)}"
  }, {
    "code": "200000029905",
    "display": "3. How to   X"
  }, {
    "code": "200000029906",
    "display": "Use in children "
  }, {
    "code": "200000029907",
    "display": "If you   more X than you should"
  }, {
    "code": "200000029908",
    "display": "If you forget to   X"
  }, {
    "code": "200000029909",
    "display": "If you stop   X"
  }, {
    "code": "200000029910",
    "display": "4. Possible side effects"
  }, {
    "code": "200000029911",
    "display": "Additional side effects in children "
  }, {
    "code": "200000029912",
    "display": "Reporting of side effects"
  }, {
    "code": "200000029913",
    "display": "5. How to store X"
  }, {
    "code": "200000029914",
    "display": "6. Contents of the pack and other information"
  }, {
    "code": "200000029915",
    "display": "What X contains"
  }, {
    "code": "200000029916",
    "display": "What X looks like and contents of the pack"
  }, {
    "code": "200000029917",
    "display": "Marketing Authorisation Holder and Manufacturer"
  }, {
    "code": "200000029918",
    "display": "This medicine is authorised in the Member States of the European Economic Area  under the following names:"
  }, {
    "code": "200000029919",
    "display": "This leaflet was last revised in <{MM/YYYY}><{month YYYY}>."
  }, {
    "code": "200000029920",
    "display": "Other sources of information"
  }, {
    "code": "200000029921",
    "display": "The following information is intended for healthcare professionals only:"
  } ],
  "caseSensitive": true,
  "version": "5.0.0"
}