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 |
20.292 03a81b61-64a0-47bf-b290-694786394e3f |
20.293 0b146816-ddb8-4fdf-ad50-bb11e6f37a85 |
20.294 1299400b-7457-4204-a783-1dd6b76d667d |
20.295 14f3feeb-6fc5-4f00-895e-58d43fba2025 |
20.296 163c6e43-79a1-4027-98ad-c76f9389d688 |
20.297 18a17a6a-2f9f-4fa1-9637-30988169af9c |
20.298 2563d8a7-6e95-46e0-abe1-ac3d84e2f885 |
20.299 39774d92-8478-4f38-b00b-47d4832e403f |
20.300 4545f61f-6697-4bf0-8bf0-10cb0026bcef |
20.301 4bb91c19-908b-47ec-b9f2-64894c210204 |
20.302 5928edc8-95cf-4059-b5d3-8a631d737c06 |
20.303 635993ca-d3f5-4bf8-aecc-053e66a0ac3b |
20.304 64988918-28b7-4662-846c-049e81f1516b |
20.305 7154a4f1-3b59-4f89-84db-76a27c67c969 |
20.306 734d4279-434d-4c51-b991-bce10a8b4604 |
20.307 8089bc7f-1934-4ad3-8436-8f4156129eab |
20.308 89c47b83-e2b0-4974-97b9-715def495d2a |
20.309 8fba5090-e7e5-41d0-9863-cc067ec840ba |
20.310 94b05190-0c4d-4862-9eda-2337dffefdbe |
20.311 971ba29f-10ee-4e2b-8522-f231932192ba |
20.312 a50f10dc-1340-40d5-98ef-8b24a0d8a5ad |
20.313 a90f7fe7-34df-4bf6-85ec-55f18071268c |
20.314 b48b7c6c-f4fa-4094-9803-112a5df59855 |
20.315 bfe10c96-8cec-4372-96a3-3d73cdb94474 |
20.316 dcb13a6f-bfb1-4dff-afa6-e627f770cdbc |
20.317 eca83c7f-4cb0-4b0d-8f7a-5f9d433f5ea3 |
20.318 ecb1f056-11d0-4890-ab17-f6736859af83 |
20.319 ef8fadaa-6305-4133-b933-2c16df70c582 |