| Package | eu.epi.february2025 |
| Resource Type | CodeSystem |
| Id | 300000000005 |
| FHIR Version | R5 |
| Source | https://simplifier.net/resolve?scope=eu.epi.february2025@1.0.0&canonical=http://ema.europa.eu/fhir/CodeSystem/300000000005 |
| URL | http://ema.europa.eu/fhir/CodeSystem/300000000005 |
| Version | 5.0.0 |
| Status | active |
| Name | EUepicapcodesystem |
| Title | EU EPI CAP QRD code values |
| Description | EU EPI CAP QRD code values |
| Content | complete |
No resources found
No resources found
No narrative content found in resource
FHIR{
"resourceType": "CodeSystem",
"status": "active",
"content": "complete",
"name": "EUepicapcodesystem",
"id": "300000000005",
"title": "EU EPI CAP QRD code values",
"description": "EU EPI CAP QRD code values",
"version": "5.0.0",
"url": "http://ema.europa.eu/fhir/CodeSystem/300000000005",
"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": "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 <and special equipment for use, administration or implantation>"
},
{
"code": "200000029842",
"display": "6.6 Special precautions for disposal <and other handling>"
},
{
"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": "200000029850",
"display": "ANNEX II"
},
{
"code": "200000029851",
"display": "A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE"
},
{
"code": "200000029852",
"display": "B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE"
},
{
"code": "200000029853",
"display": "Official batch release"
},
{
"code": "200000029854",
"display": "C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION"
},
{
"code": "200000029855",
"display": "Periodic safety update reports (PSURs)"
},
{
"code": "200000029856",
"display": "D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT"
},
{
"code": "200000029857",
"display": "Risk management plan (RMP)"
},
{
"code": "200000029858",
"display": "Additional risk minimisation measures"
},
{
"code": "200000029859",
"display": "Obligation to conduct post-authorisation measures"
},
{
"code": "200000029860",
"display": "E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR <THE CONDITIONAL MARKETING AUTHORISATION> <THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES"
},
{
"code": "200000029861",
"display": "LABELLING"
},
{
"code": "200000029862",
"display": "PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {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 <take> <use> X"
},
{
"code": "200000029897",
"display": "Do not <take> <use> X"
},
{
"code": "200000029898",
"display": "Warnings and precautions"
},
{
"code": "200000029899",
"display": "Children <and adolescents>"
},
{
"code": "200000029900",
"display": "Other medicines and X"
},
{
"code": "200000029901",
"display": "X with <food> <and> <,> <drink> <and> <alcohol>"
},
{
"code": "200000029902",
"display": "Pregnancy <and> <,> breast-feeding <and fertility>"
},
{
"code": "200000029903",
"display": "Driving and using machines"
},
{
"code": "200000029904",
"display": "X contains {name the excipient(s)}"
},
{
"code": "200000029905",
"display": "3. How to <take> <use> X"
},
{
"code": "200000029906",
"display": "Use in children <and adolescents>"
},
{
"code": "200000029907",
"display": "If you <take> <use> more X than you should"
},
{
"code": "200000029908",
"display": "If you forget to <take> <use> X"
},
{
"code": "200000029909",
"display": "If you stop <taking> <using> X"
},
{
"code": "200000029910",
"display": "4. Possible side effects"
},
{
"code": "200000029911",
"display": "Additional side effects in children <and adolescents>"
},
{
"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": "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:"
}
],
"experimental": false,
"publisher": "European Medicines Agency",
"jurisdiction": [
{
"text": "European Union"
}
],
"caseSensitive": true,
"count": 134
}