European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build
European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://ema.europa.eu/fhir/ValueSet/EUepismpcqrdcodesVs | Version: 1.0.0 | |||
| Active as of 2025-04-02 | Computable Name: EUepismpcqrdcodesVs | |||
List of section codes allowed in SmPC documents, defined in EMA's Referentials Management Service.
References
Generated Narrative: ValueSet EUepismpcqrdcodesVs
http://ema.europa.eu/fhir/CodeSystem/200000029659| Code | Display |
| 000000000000 | Code for custom sub-sections (reserved) |
| 200000029791 | SUMMARY OF PRODUCT CHARACTERISTICS |
| 200000029792 | 1. NAME OF THE MEDICINAL PRODUCT |
| 200000029793 | 2. QUALITATIVE AND QUANTITATIVE COMPOSITION |
| 200000029794 | 2.1 General description |
| 200000029795 | 2.2 Qualitative and quantitative composition |
| 200000029796 | Excipient(s) with known effect |
| 200000029797 | 3. PHARMACEUTICAL FORM |
| 200000029798 | 4. CLINICAL PARTICULARS |
| 200000029799 | 4.1 Therapeutic indications |
| 200000029800 | 4.2 Posology and method of administration |
| 200000029801 | Posology |
| 200000029802 | Paediatric population |
| 200000029803 | Method of administration |
| 200000029804 | Precautions to be taken before handling or administering the medicinal product |
| 200000029805 | 4.3 Contraindications |
| 200000029806 | 4.4 Special warnings and precautions for use |
| 200000029807 | Traceability |
| 200000029808 | Paediatric population |
| 200000029809 | 4.5 Interaction with other medicinal products and other forms of interaction |
| 200000029810 | Paediatric population |
| 200000029811 | 4.6 Fertility, pregnancy and lactation |
| 200000029812 | Pregnancy |
| 200000029813 | Breast-feeding |
| 200000029814 | Fertility |
| 200000029815 | 4.7 Effects on ability to drive and use machines |
| 200000029816 | 4.8 Undesirable effects |
| 200000029817 | Paediatric population |
| 200000029818 | Reporting of suspected adverse reactions |
| 200000029819 | 4.9 Overdose |
| 200000029820 | Paediatric population |
| 200000029821 | 5. PHARMACOLOGICAL PROPERTIES |
| 200000029822 | 5.1 Pharmacodynamic properties |
| 200000029823 | Mechanism of action |
| 200000029824 | Pharmacodynamic effects |
| 200000029825 | Clinical efficacy and safety |
| 200000029826 | Paediatric population |
| 200000029827 | 5.2 Pharmacokinetic properties |
| 200000029828 | Absorption |
| 200000029829 | Distribution |
| 200000029830 | Biotransformation |
| 200000029831 | Elimination |
| 200000029832 | Linearity/non-linearity |
| 200000029833 | Pharmacokinetic/pharmacodynamic relationship(s) |
| 200000029834 | 5.3 Preclinical safety data |
| 200000029835 | Environmental risk assessment (ERA) |
| 200000029836 | 6. PHARMACEUTICAL PARTICULARS |
| 200000029837 | 6.1 List of excipients |
| 200000029838 | 6.2 Incompatibilities |
| 200000029839 | 6.3 Shelf life |
| 200000029840 | 6.4 Special precautions for storage |
| 200000029841 | 6.5 Nature and contents of container [and special equipment for use, administration or implantation] |
| 200000029842 | 6.6 Special precautions for disposal [and other handling] |
| 200000029843 | Use in the paediatric population |
| 200000029844 | 7. MARKETING AUTHORISATION HOLDER |
| 200000029845 | 8. MARKETING AUTHORISATION NUMBER(S) |
| 200000029846 | 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION |
| 200000029847 | 10. DATE OF REVISION OF THE TEXT |
| 200000029848 | 11. DOSIMETRY |
| 200000029849 | 12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS |
| 200000044333 | Level=H4 SmPC custom subsection |
| 200000044347 | Level=H5 SmPC custom subsection |
Generated Narrative: ValueSet
Expansion done internally based on codesystem 02 Section Code System v1.0.0 (CodeSystem)
This value set contains 62 concepts
| Code | System | Display |
| 000000000000 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Code for custom sub-sections (reserved) |
| 200000029791 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | SUMMARY OF PRODUCT CHARACTERISTICS |
| 200000029792 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 1. NAME OF THE MEDICINAL PRODUCT |
| 200000029793 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 2. QUALITATIVE AND QUANTITATIVE COMPOSITION |
| 200000029794 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 2.1 General description |
| 200000029795 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 2.2 Qualitative and quantitative composition |
| 200000029796 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Excipient(s) with known effect |
| 200000029797 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 3. PHARMACEUTICAL FORM |
| 200000029798 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4. CLINICAL PARTICULARS |
| 200000029799 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.1 Therapeutic indications |
| 200000029800 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.2 Posology and method of administration |
| 200000029801 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Posology |
| 200000029802 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Paediatric population |
| 200000029803 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Method of administration |
| 200000029804 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Precautions to be taken before handling or administering the medicinal product |
| 200000029805 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.3 Contraindications |
| 200000029806 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.4 Special warnings and precautions for use |
| 200000029807 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Traceability |
| 200000029808 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Paediatric population |
| 200000029809 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.5 Interaction with other medicinal products and other forms of interaction |
| 200000029810 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Paediatric population |
| 200000029811 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.6 Fertility, pregnancy and lactation |
| 200000029812 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Pregnancy |
| 200000029813 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Breast-feeding |
| 200000029814 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Fertility |
| 200000029815 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.7 Effects on ability to drive and use machines |
| 200000029816 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.8 Undesirable effects |
| 200000029817 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Paediatric population |
| 200000029818 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Reporting of suspected adverse reactions |
| 200000029819 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 4.9 Overdose |
| 200000029820 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Paediatric population |
| 200000029821 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 5. PHARMACOLOGICAL PROPERTIES |
| 200000029822 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 5.1 Pharmacodynamic properties |
| 200000029823 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Mechanism of action |
| 200000029824 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Pharmacodynamic effects |
| 200000029825 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Clinical efficacy and safety |
| 200000029826 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Paediatric population |
| 200000029827 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 5.2 Pharmacokinetic properties |
| 200000029828 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Absorption |
| 200000029829 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Distribution |
| 200000029830 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Biotransformation |
| 200000029831 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Elimination |
| 200000029832 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Linearity/non-linearity |
| 200000029833 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Pharmacokinetic/pharmacodynamic relationship(s) |
| 200000029834 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 5.3 Preclinical safety data |
| 200000029835 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Environmental risk assessment (ERA) |
| 200000029836 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 6. PHARMACEUTICAL PARTICULARS |
| 200000029837 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 6.1 List of excipients |
| 200000029838 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 6.2 Incompatibilities |
| 200000029839 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 6.3 Shelf life |
| 200000029840 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 6.4 Special precautions for storage |
| 200000029841 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 6.5 Nature and contents of container [and special equipment for use, administration or implantation] |
| 200000029842 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 6.6 Special precautions for disposal [and other handling] |
| 200000029843 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Use in the paediatric population |
| 200000029844 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 7. MARKETING AUTHORISATION HOLDER |
| 200000029845 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 8. MARKETING AUTHORISATION NUMBER(S) |
| 200000029846 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION |
| 200000029847 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 10. DATE OF REVISION OF THE TEXT |
| 200000029848 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 11. DOSIMETRY |
| 200000029849 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | 12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS |
| 200000044333 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Level=H4 SmPC custom subsection |
| 200000044347 | http://ema.europa.eu/fhir/CodeSystem/200000029659 | Level=H5 SmPC custom subsection |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |