 0 Table of Contents |
  1 Overview |
  2 Functional Analysis |
  3 Core ePI Profile |
  4 Terminology |
  5 Capability |
  6 General Technical Conformance Requirements |
  7 Persona Dimensions |
  8 ePI Processing |
  9 Semantic Annotation |
  10 IPS Considerations |
  11 Project Workflow |
  12 Project Operations |
  13 Annotation |
  14 Focus |
  15 International |
  16 Project |
  17 Focusing |
  18 Content Trust Framework |
  19 Downloads |
  20 Artifacts Summary |
   20.1 Bundle - Patient Medication Information for Xyntha® Lyophilized Powder for Reconstitution in a Vial |
   20.2 Bundle - Product Monograph for Xyntha® Lyophilized Powder for Reconstitution in a Vial |
   20.3 Bundle Japan JA - Package Insert for Herceptin (trastazumab) 150 mg for Intravenous Use |
   20.4 Bundle Japan JA - Package Insert for Simvastatin 20 mg tablets |
   20.5 Bundle Japan JA - Package Insert for Tegretol (carbamazepine) 200 mg for tablet |
   20.6 ePI document Bundle for acmedrug-man Package Leaflet for language en |
   20.7 ePI document Bundle for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion Package Leaflet for language en |
   20.8 ePI document Bundle for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion Package Leaflet for language es |
   20.9 ePI document Bundle for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion Package Leaflet for language pt |
   20.10 ePI document Bundle for Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes Package Leaflet for language es |
   20.11 ePI document Bundle for Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Package Leaflet for language en |
   20.12 ePI document Bundle for Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Package Leaflet for language es |
   20.13 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language en |
   20.14 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language es |
   20.15 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language pt |
   20.16 ePI document Bundle for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Package Leaflet for language en |
   20.17 ePI document Bundle for zithromax (azithromycin) 250 mg capsules - Jordanian Package Leaflet |
   20.18 ePI document Bundle for zithromax (azithromycin) 250 mg capsules - zithromax (azithromycin) 250 mg capsules - النشرة الداخلية: معلومات للمريض - كبسولات زيثروماكس® 250 مجم |
   20.19 FK32284 |
   20.20 FK37127 |
   20.21 FK37144 |
   20.22 FK37796 |
   20.23 FK37812 |
   20.24 FK39570 |
   20.25 FK39664 |
   20.26 FK40274 |
   20.27 FK40703 |
   20.28 FK40963 |
   20.29 FK42542 |
   20.30 FK45691 |
   20.31 FK47204 |
   20.32 FK47224 |
   20.33 FK47338 |
   20.34 FK545701 |
   20.35 FK545731 |
   20.36 FK545786 |
   20.37 FK545787 |
   20.38 FK545806 |
   20.39 FK545852 |
   20.40 FK546114 |
   20.41 FK546405 |
   20.42 FK546406 |
   20.43 FK546487 |
   20.44 FK560831 |
   20.45 FK567097 |
   20.46 FK58843 |
   20.47 FK589544 |
   20.48 FK589551 |
   20.49 FK60041 |
   20.50 FK630702 |
   20.51 FK630703 |
   20.52 FK630704 |
   20.53 FK637674 |
   20.54 FK653969 |
   20.55 FK653990 |
   20.56 FK654011 |
   20.57 FK66447 |
   20.58 FK66491 |
   20.59 FK82671 |
   20.60 FK85746 |
   20.61 FK86169 |
   20.62 FK96760 |
   20.63 [Preprocessed] ePI document Bundle for Karvea 75 mg Package Leaflet |
   20.64 [Preprocessed] ePI document for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
   20.65 [Preprocessed] ePI document for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet |
   20.66 [Preprocessed] ePI document for Dovato 50 mg/300 mg comprimidos Package Leaflet |
   20.67 [Preprocessed] ePI document for Dovato 50 mg/300 mg comprimidos Package Leaflet |
   20.68 [Preprocessed] ePI document for Flucelvax Package Leaflet |
   20.69 [Preprocessed] ePI document for Flucelvax Package Leaflet in ES |
   20.70 [Preprocessed] ePI document for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet |
   20.71 [Processed] ePI document Bundle for biktarvy-es Package Leaflet for language es |
   20.72 [Processed] ePI document Bundle for biktarvy-pt Package Leaflet for language pt |
   20.73 [Enhanced-Alicia] ePI document for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
   20.74 [Enhanced-Alicia] ePI document for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet |
   20.75 [Enhanced-Alicia] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet EN |
   20.76 [Enhanced-Alicia] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet ES |
   20.77 [Enhanced-Alicia] ePI document for Flucelvax Package Leaflet |
   20.78 [Enhanced-Alicia] ePI document for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet |
   20.79 [Enhanced-Alicia] ePI document for Karvea 75 mg Package Leaflet |
   20.80 [Enhanced-Pedro] ePI document for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
   20.81 [Enhanced-Pedro] ePI document for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet |
   20.82 [Enhanced-pedro] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet EN |
   20.83 [Enhanced-pedro] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet ES |
   20.84 [Enhanced-Pedro] ePI document for Flucelvax Package Leaflet |
   20.85 [Enhanced-Pedro] ePI document for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet |
   20.86 [Enhanced-Pedro] ePI document for Karvea 75 mg Package Leaflet |
   20.87 [Enhanced] ePI document Bundle for Karvea 75 mg Package Leaflet |
   20.88 capabilityStatement |
   20.89 ai-summary |
   20.90 annotate |
   20.91 diff |
   20.92 focus |
   20.93 composition-category |
   20.94 Additional Support Material Profile |
   20.95 Focused Composition Profile |
   20.96 Lens Profile |
   20.97 Persona Dimension Collection |
   20.98 Provenance Profile |
   20.99 Summary Data Profile |
   20.100 Blockchain Transaction ID |
   20.101 HtmlElementLink |
   20.102 LEEversion |
   20.103 LensesApplied |
   20.104 RelatedMedicalIssue |
   20.105 VisualizationMethod |
   20.106 ASMCategoryVS |
   20.107 LensCategories |
   20.108 PDcategoryVS |
   20.109 PDtypeVS |
   20.110 ThreepointCategoryVS |
   20.111 TypeOfDataVS |
   20.112 Category of ASM |
   20.113 Category of EPI |
   20.114 Example ICPC2 CS |
   20.115 LensCategoriesCodes |
   20.116 Persona Vector Dimensions categories |
   20.117 Persona Vector Dimensions Code |
   20.118 Questionnaire example Dimensions |
   20.119 Type of information to be added in epi CS |
   20.120 SNOMED CT to ICD-10-CM mappings for fracture of ulna |
   20.121 SNOMED CT to ICD-10-CM mappings for fracture of ulna |
   20.122 SNOMED CT to ICD-10-CM mappings for fracture of ulna |
   20.123 Actrapid 100 UI/ml (unidades internacionais/ml) solução injetável em frasco para injetáveis |
   20.124 Actrapid 100 UI/ml (unidades internacionais/ml) solução injetável em frasco para injetáveis |
   20.125 allergy-lens |
   20.126 bundle-ibrance75-100-125 |
   20.127 bundlepackageleaflet-enbrelsolution |
   20.128 bundlepackageleaflet-xeljanz |
   20.129 Composition for Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película Package Leaflet |
   20.130 Composition for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
   20.131 Composition for Flucelvax Package Leaflet - preprocessed ES |
   20.132 Composition for Humalog Package Leaflet- Preprocessed |
   20.133 Composition for Karvea Package Leaflet PT Preprocessed |
   20.134 condition-lens |
   20.135 DPHARM123 |
   20.136 ePI document Bundle for amoxicillin 250 mg tablets Package Leaflet for language en |
   20.137 ePI document Bundle for Aquilea Articulaciones Colageno y Magnesio 375gr Package Leaflet for language es |
   20.138 ePI document Bundle for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion Package Leaflet for language da |
   20.139 ePI document Bundle for BLASTON 1 mg tablets Package Leaflet for language es |
   20.140 ePI document Bundle for BLASTON 1 mg tablets Package Leaflet for language es |
   20.141 ePI document Bundle for Calcichew-D3 Forte Package Leaflet for language en |
   20.142 ePI document Bundle for DOLOCATIL 1 g tablets Package Leaflet for language en |
   20.143 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language da |
   20.144 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language en |
   20.145 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language es |
   20.146 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language pt |
   20.147 ePI document Bundle for Enbrel 25 mg powder for solution for injection Package Leaflet for language en |
   20.148 ePI document Bundle for Fluenz Tetra nasal spray suspension Package Leaflet for language en |
   20.149 ePI document Bundle for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet for language es |
   20.150 ePI document Bundle for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill Package Leaflet for language da |
   20.151 ePI document Bundle for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill Package Leaflet for language en |
   20.152 ePI document Bundle for Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) Package Leaflet for language en |
   20.153 ePI document Bundle for Ibuprofen 600 mg tablet Package Leaflet for language en |
   20.154 ePI document Bundle for Ibuprofen 600 mg tablet Package Leaflet for language en |
   20.155 ePI document Bundle for Ibuprofen 600 mg tablet Package Leaflet for language en |
   20.156 ePI document Bundle for Karvea 75 mg Package Leaflet for language pt |
   20.157 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language da |
   20.158 ePI document Bundle for Lipcut Simvastatin 5 mg Tablet Package Leaflet for language en |
   20.159 ePI document Bundle for Metformin 500 mg tablet Package Leaflet for language en |
   20.160 ePI document Bundle for MIRTAZAPINA CINFA 30 mg Coated Tablet Package Leaflet for language es |
   20.161 ePI document Bundle for MIRTAZAPINA CINFA 30 mg Coated Tablet Package Leaflet for language es |
   20.162 ePI document Bundle for Mo Package Leaflet for language en |
   20.163 ePI document Bundle for Natures Plus Spiru-Tein Package Leaflet for language es |
   20.164 ePI document Bundle for Novorapid Flexpen 100 units/ml solution for injection in pre-filled pen Package Leaflet for language en |
   20.165 ePI document Bundle for Novorapid Flexpen 100 units/ml solution for injection in pre-filled pen Package Leaflet for language en |
   20.166 ePI document Bundle for Nurofen 100 mg Chewable Capsules Package Leaflet for language en |
   20.167 ePI document Bundle for Ogivri 150 mg powder for concentrate for solution for infusion Package Leaflet for language en |
   20.168 ePI document Bundle for Pentasa Slow Release Tablets 1g Package Leaflet for language es |
   20.169 ePI document Bundle for Remsima 100 mg powder for concentrate for solution for infusion Package Leaflet for language en |
   20.170 ePI document Bundle for Skilarence 120 mg gastro-resistant tablets Package Leaflet for language en |
   20.171 ePI document Bundle for SORIA NATURAL VITAMINA C 36 COMPRIMIDOS Package Leaflet for language es |
   20.172 ePI document Bundle for Tegretol 200 mg tablets Package Leaflet for language en |
   20.173 ePI document Bundle for Tegretol 200 mg tablets Package Leaflet for language en |
   20.174 ePI document Bundle for Tegretol 200 mg tablets Package Leaflet for language es |
   20.175 ePI document Bundle for Tegretol 200 mg tablets Package Leaflet for language es |
   20.176 ePI document Bundle for Xenical 120mg hard capsules Package Leaflet for language en |
   20.177 ePI document Bundle for Xenical 120mg hard capsules Package Leaflet for language en |
   20.178 ePI document Bundle for Xenical 120mg hard capsules Package Leaflet for language es |
   20.179 ePI document Bundle for Xenical 120mg hard capsules Package Leaflet for language es |
   20.180 Example of additional support material - BUILTIN PDF |
   20.181 Example of additional support material - Structured Content |
   20.182 Example of additional support material - test match for alicia and flucelvax |
   20.183 Example of additional support material - test match for alicia, HIV and biktarvy - test audio |
   20.184 Example of additional support material - test match for alicia, HIV and biktarvy - test document |
   20.185 Example of additional support material - test match for alicia, HIV and biktarvy - test image |
   20.186 Example of additional support material - test match for alicia, HIV and biktarvy - test video |
   20.187 Example of additional support material - test match for alicia, only condition |
   20.188 Example of additional support material - URL |
   20.189 Example of Provenance to be part of CTF |
   20.190 Glimepirida Generis |
   20.191 Glimepirida Generis |
   20.192 GLUCOPHAGE |
   20.193 GLUCOPHAGE |
   20.194 Infarmed |
   20.195 interaction-lens |
   20.196 List of Aclasta inf, oppl 5 mg/100 ml Package Leaflets |
   20.197 List of Actrapid Penfill inj, oppl 100 IE/ml Package Leaflets |
   20.198 List of Aerobec Autohaler inh aerosol, oppl 100 mikrog/dose Package Leaflets |
   20.199 List of Aerobec inh aerosol, oppl 100 mikrog/dose Package Leaflets |
   20.200 List of Airomir Autohaler inh aerosol, susp 0,1 mg/dose Package Leaflets |
   20.201 List of Alendronat Mylan tab 70 mg Package Leaflets |
   20.202 List of all ePIs associated with acmedrug |
   20.203 List of all ePIs associated with amox |
   20.204 List of all ePIs associated with aquilea |
   20.205 List of all ePIs associated with biktarvy |
   20.206 List of all ePIs associated with calchichew-d3f |
   20.207 List of all ePIs associated with calcio_vitamina_d |
   20.208 List of all ePIs associated with cinitrapide |
   20.209 List of all ePIs associated with domperidone |
   20.210 List of all ePIs associated with dovato |
   20.211 List of all ePIs associated with enbrel |
   20.212 List of all ePIs associated with flucelvax |
   20.213 List of all ePIs associated with hipérico_arkopharma |
   20.214 List of all ePIs associated with humalog |
   20.215 List of all ePIs associated with humira |
   20.216 List of all ePIs associated with ibuprofen |
   20.217 List of all ePIs associated with karvea |
   20.218 List of all ePIs associated with mirtazapine |
   20.219 List of all ePIs associated with naturesplus |
   20.220 List of all ePIs associated with paracetamol |
   20.221 List of all ePIs associated with pentasa |
   20.222 List of all ePIs associated with remsima |
   20.223 List of all ePIs associated with simvastatine |
   20.224 List of all ePIs associated with skilarence |
   20.225 List of all ePIs associated with soria |
   20.226 List of all ePIs associated with suliqua |
   20.227 List of all ePIs associated with tegretol |
   20.228 List of all ePIs associated with trastuzumab |
   20.229 List of all ePIs associated with vaxigriptetra |
   20.230 List of all ePIs associated with xenical |
   20.231 List of Apidra inj, oppl 100 E/ml Package Leaflets |
   20.232 List of Aprovel tab 150 mg Package Leaflets |
   20.233 List of Aprovel tab 300 mg Package Leaflets |
   20.234 List of Asacol enterotab 400 mg Package Leaflets |
   20.235 List of Cortiment depottab 9 mg Package Leaflets |
   20.236 List of DuoResp Spiromax inh pulv 160 mikrog/4,5 mikrog Package Leaflets |
   20.237 List of DuoResp Spiromax inh pulv 320 mikrog/9 mikrog Package Leaflets |
   20.238 List of Enbrel (etanercept) 50 mg/ml solution for subcutaneous injection Package Leaflets |
   20.239 List of enbrel smpc Package Leaflets |
   20.240 List of Galvus tab 50 mg Package Leaflets |
   20.241 List of Humira inj, oppl 40 mg/sprøyte Package Leaflets |
   20.242 List of Hyrimoz inj, oppl 40 mg/penn Package Leaflets |
   20.243 List of Hyrimoz inj, oppl 40 mg/sprøyte Package Leaflets |
   20.244 List of Imurel tab 25 mg Package Leaflets |
   20.245 List of Janumet tab 50 mg/1000 mg Package Leaflets |
   20.246 List of Januvia tab 100 mg Package Leaflets |
   20.247 List of Jyseleca tab 100 mg Package Leaflets |
   20.248 List of Lantus inj, oppl 100 E/ml Package Leaflets |
   20.249 List of Lantus inj, oppl 100 E/ml Package Leaflets |
   20.250 List of NovoRapid Flexpen inj, oppl 100 E/ml Package Leaflets |
   20.251 List of NovoRapid inj, oppl 100 E/ml Package Leaflets |
   20.252 List of NovoRapid Penfill inj, oppl 100 E/ml Package Leaflets |
   20.253 List of NovoRapid PumpCart inj, oppl 100 E/ml Package Leaflets |
   20.254 List of Ozempic inj, oppl 0,25 mg/0,19 ml Package Leaflets |
   20.255 List of Ozempic inj, oppl 0,5 mg/0,37 ml Package Leaflets |
   20.256 List of Ozempic inj, oppl 1 mg/0,74 ml Package Leaflets |
   20.257 List of Pentasa depottab 1 g Package Leaflets |
   20.258 List of Pentasa depottab 500 mg Package Leaflets |
   20.259 List of Prednisolon Unimedic rektalvæske, oppl 31,25 mg Package Leaflets |
   20.260 List of Remicade pulv til kons til inf væske, oppl 100 mg Package Leaflets |
   20.261 List of Stelara inj, oppl 45 mg/sprøyte Package Leaflets |
   20.262 List of Stelara inj, oppl 90 mg/sprøyte Package Leaflets |
   20.263 List of Ventoline inh pulv, disp 0,2 mg/dose Package Leaflets |
   20.264 List of Ventoline inh væske, oppl 5 mg/ml Package Leaflets |
   20.265 List of Xeljanz tab 10 mg Package Leaflets |
   20.266 manitemherceptin150 |
   20.267 Marketing Authorization Holder - Chugai Pharmaceutical Co., Ltd. |
   20.268 Marketing Authorization Holder - Ohara Pharmaceutical Co., Ltd. |
   20.269 Medicinal Product - Herceptin (trastazumab) 150 mg for Intravenous Use |
   20.270 MPD-33095 |
   20.271 MPD-3975 |
   20.272 MPD-619944 |
   20.273 ORG1 |
   20.274 packherceptinvial |
   20.275 Pedro Persona Vector - Collection |
   20.276 Persona Dimension - Collection |
   20.277 pregnancy-lens |
   20.278 PT-Actrapid |
   20.279 PT-Actrapid-processed-bundle |
   20.280 PT-Glimepirida-Generis |
   20.281 PT-Glimepirida-Generis-processed-bundle |
   20.282 PT-GLUCOPHAGE |
   20.283 PT-GLUCOPHAGE-processed-bundle |
   20.284 Questionnaire-example |
   20.285 QuestionnaireResponse-example |
   20.286 Regulated Authorization - Herceptin (trastazumab) 150 mg for Intravenous Use |
   20.287 rmm-lens |
   20.288 Substance - simvastatin |
   20.289 Substance - trastazumab |
   20.290 summary-lens |
   20.291 Tentative medical device - example |