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 Artifacts Summary |
18.1 Bundle - Patient Medication Information for Xyntha® Lyophilized Powder for Reconstitution in a Vial |
18.2 Bundle - Product Monograph for Xyntha® Lyophilized Powder for Reconstitution in a Vial |
18.3 Bundle Japan JA - Package Insert for Herceptin (trastazumab) 150 mg for Intravenous Use |
18.4 Bundle Japan JA - Package Insert for Simvastatin 20 mg tablets |
18.5 Bundle Japan JA - Package Insert for Tegretol (carbamazepine) 200 mg for tablet |
18.6 ePI document Bundle for acmedrug-man Package Leaflet for language en |
18.7 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 |
18.8 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 |
18.9 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 |
18.10 ePI document Bundle for Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes Package Leaflet for language es |
18.11 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 |
18.12 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 |
18.13 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language en |
18.14 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language es |
18.15 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language pt |
18.16 ePI document Bundle for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Package Leaflet for language en |
18.17 ePI document Bundle for zithromax (azithromycin) 250 mg capsules - Jordanian Package Leaflet |
18.18 ePI document Bundle for zithromax (azithromycin) 250 mg capsules - zithromax (azithromycin) 250 mg capsules - النشرة الداخلية: معلومات للمريض - كبسولات زيثروماكس® 250 مجم |
18.19 FK32284 |
18.20 FK37127 |
18.21 FK37144 |
18.22 FK37796 |
18.23 FK37812 |
18.24 FK39570 |
18.25 FK39664 |
18.26 FK40274 |
18.27 FK40703 |
18.28 FK40963 |
18.29 FK42542 |
18.30 FK45691 |
18.31 FK47204 |
18.32 FK47224 |
18.33 FK47338 |
18.34 FK545701 |
18.35 FK545731 |
18.36 FK545786 |
18.37 FK545787 |
18.38 FK545806 |
18.39 FK545852 |
18.40 FK546114 |
18.41 FK546405 |
18.42 FK546406 |
18.43 FK546487 |
18.44 FK560831 |
18.45 FK567097 |
18.46 FK58843 |
18.47 FK589544 |
18.48 FK589551 |
18.49 FK60041 |
18.50 FK630702 |
18.51 FK630703 |
18.52 FK630704 |
18.53 FK637674 |
18.54 FK653969 |
18.55 FK653990 |
18.56 FK654011 |
18.57 FK66447 |
18.58 FK66491 |
18.59 FK82671 |
18.60 FK85746 |
18.61 FK86169 |
18.62 FK96760 |
18.63 [Preprocessed] ePI document Bundle for Karvea 75 mg Package Leaflet |
18.64 [Preprocessed] ePI document for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
18.65 [Preprocessed] ePI document for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet |
18.66 [Preprocessed] ePI document for Dovato 50 mg/300 mg comprimidos Package Leaflet |
18.67 [Preprocessed] ePI document for Dovato 50 mg/300 mg comprimidos Package Leaflet |
18.68 [Preprocessed] ePI document for Flucelvax Package Leaflet |
18.69 [Preprocessed] ePI document for Flucelvax Package Leaflet in ES |
18.70 [Preprocessed] ePI document for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet |
18.71 [Processed] ePI document Bundle for biktarvy-es Package Leaflet for language es |
18.72 [Processed] ePI document Bundle for biktarvy-pt Package Leaflet for language pt |
18.73 [Enhanced-Alicia] ePI document for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
18.74 [Enhanced-Alicia] ePI document for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet |
18.75 [Enhanced-Alicia] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet EN |
18.76 [Enhanced-Alicia] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet ES |
18.77 [Enhanced-Alicia] ePI document for Flucelvax Package Leaflet |
18.78 [Enhanced-Alicia] ePI document for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet |
18.79 [Enhanced-Alicia] ePI document for Karvea 75 mg Package Leaflet |
18.80 [Enhanced-Pedro] ePI document for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
18.81 [Enhanced-Pedro] ePI document for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet |
18.82 [Enhanced-pedro] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet EN |
18.83 [Enhanced-pedro] ePI document for Dovato 50 mg/300 mg tablets Package Leaflet ES |
18.84 [Enhanced-Pedro] ePI document for Flucelvax Package Leaflet |
18.85 [Enhanced-Pedro] ePI document for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet |
18.86 [Enhanced-Pedro] ePI document for Karvea 75 mg Package Leaflet |
18.87 [Enhanced] ePI document Bundle for Karvea 75 mg Package Leaflet |
18.88 capabilityStatement |
18.89 annotate |
18.90 diff |
18.91 focus |
18.92 Additional Support Material Profile |
18.93 Lens Profile |
18.94 Persona Dimension Collection |
18.95 Provenance Profile |
18.96 Summary Data Profile |
18.97 AdditionalInformation |
18.98 HtmlElementLink |
18.99 LEEversion |
18.100 LensesApplied |
18.101 relatedMedicalIssue |
18.102 PDcategoryVS |
18.103 PDtypeVS |
18.104 ThreepointCategoryVS |
18.105 TypeOfDataVS |
18.106 Category of EPI |
18.107 Example ICPC2 CS |
18.108 Persona Vector Dimensions categories |
18.109 Persona Vector Dimensions Code |
18.110 Questionnaire example Dimensions |
18.111 Type of information to be added in epi CS |
18.112 Bundle for returning searchset of lenses |
18.113 bundle-ibrance75-100-125 |
18.114 bundlepackageleaflet-enbrelsolution |
18.115 bundlepackageleaflet-talzenna1and025 |
18.116 bundlepackageleaflet-xeljanz |
18.117 Composition for Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película Package Leaflet |
18.118 Composition for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
18.119 Composition for Flucelvax Package Leaflet - preprocessed ES |
18.120 Composition for Humalog Package Leaflet- Preprocessed |
18.121 Composition for Karvea Package Leaflet PT Preprocessed |
18.122 contraindication |
18.123 DPHARM123 |
18.124 ePI document Bundle for amoxicillin 250 mg tablets Package Leaflet for language en |
18.125 ePI document Bundle for Aquilea Articulaciones Colageno y Magnesio 375gr Package Leaflet for language es |
18.126 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 dk |
18.127 ePI document Bundle for BLASTON 1 mg tablets Package Leaflet for language es |
18.128 ePI document Bundle for Calcichew-D3 Forte Package Leaflet for language en |
18.129 ePI document Bundle for DOLOCATIL 1 g tablets Package Leaflet for language en |
18.130 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language dk |
18.131 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language en |
18.132 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language es |
18.133 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language pt |
18.134 ePI document Bundle for Enbrel 25 mg powder for solution for injection Package Leaflet for language en |
18.135 ePI document Bundle for Fluenz Tetra nasal spray suspension Package Leaflet for language en |
18.136 ePI document Bundle for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet for language es |
18.137 ePI document Bundle for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill Package Leaflet for language dk |
18.138 ePI document Bundle for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill Package Leaflet for language en |
18.139 ePI document Bundle for Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) Package Leaflet for language en |
18.140 ePI document Bundle for Karvea 75 mg Package Leaflet for language pt |
18.141 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language dk |
18.142 ePI document Bundle for Lipcut Simvastatin 5 mg Tablet Package Leaflet for language en |
18.143 ePI document Bundle for MIRTAZAPINA CINFA 30 mg Coated Tablet Package Leaflet for language es |
18.144 ePI document Bundle for Mo Package Leaflet for language en |
18.145 ePI document Bundle for Natures Plus Spiru-Tein Package Leaflet for language es |
18.146 ePI document Bundle for Nurofen 100 mg Chewable Capsules Package Leaflet for language en |
18.147 ePI document Bundle for Ogivri 150 mg powder for concentrate for solution for infusion Package Leaflet for language en |
18.148 ePI document Bundle for Pentasa Slow Release Tablets 1g Package Leaflet for language en |
18.149 ePI document Bundle for Remsima 100 mg powder for concentrate for solution for infusion Package Leaflet for language en |
18.150 ePI document Bundle for Skilarence 120 mg gastro-resistant tablets Package Leaflet for language en |
18.151 ePI document Bundle for SORIA NATURAL VITAMINA C 36 COMPRIMIDOS Package Leaflet for language es |
18.152 ePI document Bundle for Talzenna® (talazoparib) 0.25 mg and 1mg hard capsules |
18.153 ePI document Bundle for Tegretol 200 mg tablets Package Leaflet for language es |
18.154 ePI document Bundle for Xenical 120mg hard capsules Package Leaflet for language en |
18.155 ePI document Bundle for Xenical 120mg hard capsules Package Leaflet for language es |
18.156 Example of additional support material - BUILTIN PDF |
18.157 Example of additional support material - Structured Content |
18.158 Example of additional support material - test match for alicia and flucelvax |
18.159 Example of additional support material - test match for alicia, HIV and biktarvy |
18.160 Example of additional support material - test match for alicia, only condition |
18.161 Example of additional support material - URL |
18.162 Example of Provenance to be part of CTF |
18.163 List of Aclasta inf, oppl 5 mg/100 ml Package Leaflets |
18.164 List of Actrapid Penfill inj, oppl 100 IE/ml Package Leaflets |
18.165 List of Aerobec Autohaler inh aerosol, oppl 100 mikrog/dose Package Leaflets |
18.166 List of Aerobec inh aerosol, oppl 100 mikrog/dose Package Leaflets |
18.167 List of Airomir Autohaler inh aerosol, susp 0,1 mg/dose Package Leaflets |
18.168 List of Alendronat Mylan tab 70 mg Package Leaflets |
18.169 List of Apidra inj, oppl 100 E/ml Package Leaflets |
18.170 List of Aprovel tab 150 mg Package Leaflets |
18.171 List of Aprovel tab 300 mg Package Leaflets |
18.172 List of Asacol enterotab 400 mg Package Leaflets |
18.173 List of biktarvy Package Leaflets |
18.174 List of Cortiment depottab 9 mg Package Leaflets |
18.175 List of dovato Package Leaflets |
18.176 List of DuoResp Spiromax inh pulv 160 mikrog/4,5 mikrog Package Leaflets |
18.177 List of DuoResp Spiromax inh pulv 320 mikrog/9 mikrog Package Leaflets |
18.178 List of Enbrel (etanercept) 50 mg/ml solution for subcutaneous injection Package Leaflets |
18.179 List of enbrel smpc Package Leaflets |
18.180 List of flucelvax Package Leaflets Raw |
18.181 List of Galvus tab 50 mg Package Leaflets |
18.182 List of humalog Package Leaflets Raw |
18.183 List of Humira inj, oppl 40 mg/sprøyte Package Leaflets |
18.184 List of Hyrimoz inj, oppl 40 mg/penn Package Leaflets |
18.185 List of Hyrimoz inj, oppl 40 mg/sprøyte Package Leaflets |
18.186 List of Imurel tab 25 mg Package Leaflets |
18.187 List of Janumet tab 50 mg/1000 mg Package Leaflets |
18.188 List of Januvia tab 100 mg Package Leaflets |
18.189 List of Jyseleca tab 100 mg Package Leaflets |
18.190 List of karvea Package Leaflets Raw |
18.191 List of Lantus inj, oppl 100 E/ml Package Leaflets |
18.192 List of Lantus inj, oppl 100 E/ml Package Leaflets |
18.193 List of NovoRapid Flexpen inj, oppl 100 E/ml Package Leaflets |
18.194 List of NovoRapid inj, oppl 100 E/ml Package Leaflets |
18.195 List of NovoRapid Penfill inj, oppl 100 E/ml Package Leaflets |
18.196 List of NovoRapid PumpCart inj, oppl 100 E/ml Package Leaflets |
18.197 List of Ozempic inj, oppl 0,25 mg/0,19 ml Package Leaflets |
18.198 List of Ozempic inj, oppl 0,5 mg/0,37 ml Package Leaflets |
18.199 List of Ozempic inj, oppl 1 mg/0,74 ml Package Leaflets |
18.200 List of Pentasa depottab 1 g Package Leaflets |
18.201 List of Pentasa depottab 500 mg Package Leaflets |
18.202 List of Prednisolon Unimedic rektalvæske, oppl 31,25 mg Package Leaflets |
18.203 List of Remicade pulv til kons til inf væske, oppl 100 mg Package Leaflets |
18.204 List of Stelara inj, oppl 45 mg/sprøyte Package Leaflets |
18.205 List of Stelara inj, oppl 90 mg/sprøyte Package Leaflets |
18.206 List of Ventoline inh pulv, disp 0,2 mg/dose Package Leaflets |
18.207 List of Ventoline inh væske, oppl 5 mg/ml Package Leaflets |
18.208 List of Xeljanz tab 10 mg Package Leaflets |
18.209 List of xenical Package Leaflets Raw |
18.210 manitemherceptin150 |
18.211 Marketing Authorization Holder - Chugai Pharmaceutical Co., Ltd. |
18.212 Marketing Authorization Holder - Ohara Pharmaceutical Co., Ltd. |
18.213 Medicinal Product - Herceptin (trastazumab) 150 mg for Intravenous Use |
18.214 Medicinal Product cava 75 mg tablet in blister pack of 28 tablets |
18.215 packherceptinvial |
18.216 Pedro Persona Vector - Collection |
18.217 Persona Dimension - Collection |
18.218 Questionnaire-example |
18.219 QuestionnaireResponse-example |
18.220 Regulated Authorization - Herceptin (trastazumab) 150 mg for Intravenous Use |
18.221 Substance - simvastatin |
18.222 Substance - trastazumab |
18.223 This is a mock Lens to show how to apply them to epi |
18.224 This is a mock Lens to show how to apply them to epi |