 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 Operations |
  12 Annotation |
  13 Focus |
  14 International |
  15 Project |
  16 Artifacts Summary |
   16.1 capabilityStatement |
   16.2 annotate |
   16.3 diff |
   16.4 focus |
   16.5 Additional Support Material Profile |
   16.6 Lens Profile |
   16.7 Persona Dimension - Digital Literacy |
   16.8 Persona Dimension - health Literacy |
   16.9 Persona Dimension Collection |
   16.10 HtmlElementLink |
   16.11 HtmlElementLinkV3 |
   16.12 Lenses |
   16.13 PDcategoryVS |
   16.14 PDtypeVS |
   16.15 ThreepointCategoryVS |
   16.16 Category of EPI |
   16.17 Example ICPC2 CS |
   16.18 Persona Vector Dimensions categories |
   16.19 Persona Vector Dimensions Code |
   16.20 Questionnaire example Dimensions |
   16.21 ACME industry as Marketing authorisation holder |
   16.22 ACME industry as Marketing authorisation holder |
   16.23 ACME industry as Marketing authorisation holder |
   16.24 ACME industry as Marketing authorisation holder |
   16.25 ACME industry as Marketing authorisation holder |
   16.26 Administrable product Aquilea Articulaciones Colageno y Magnesio 375gr |
   16.27 Administrable product Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion |
   16.28 Administrable product BLASTON 1 mg tablets |
   16.29 Administrable product Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes |
   16.30 Administrable product DOLOCATIL 1 g tablets |
   16.31 Administrable product Dovato 50 mg/300 mg film-coated tablets |
   16.32 Administrable product Enbrel 25 mg powder for solution for injection |
   16.33 Administrable product Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) |
   16.34 Administrable product Fluenz Tetra nasal spray suspension |
   16.35 Administrable product HIPÉRICO ARKOPHARMA cápsulas duras |
   16.36 Administrable product Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill |
   16.37 Administrable product Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) |
   16.38 Administrable product Karvea 75 mg tablet |
   16.39 Administrable product Lipcut Simvastatin 5 mg Tablet |
   16.40 Administrable product MIRTAZAPINA CINFA 30 mg Coated Tablet |
   16.41 Administrable product Natures Plus Spiru-Tein |
   16.42 Administrable product Nurofen 100 mg Chewable Capsules |
   16.43 Administrable product Ogivri 150 mg powder for concentrate for solution for infusion |
   16.44 Administrable product Pentasa Slow Release Tablets 1g |
   16.45 Administrable product Remsima 100 mg powder for concentrate for solution for infusion |
   16.46 Administrable product Skilarence 120 mg gastro-resistant tablets |
   16.47 Administrable product SORIA NATURAL VITAMINA C 36 COMPRIMIDOS |
   16.48 Administrable product Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen |
   16.49 Administrable product Tegretol 200 mg tablets |
   16.50 Administrable product Xenical 120mg hard capsules |
   16.51 Arkopharma LABORATORIOS, S.A.U, as Marketing authorisation holder |
   16.52 AstraZeneca AB as Marketing authorisation holder |
   16.53 Celltrion Healthcare Hungary Kft. as Marketing authorisation holder |
   16.54 CHEPLAPHARM Arzneimittel GmbH as Marketing authorisation holder |
   16.55 Composition for Aquilea Articulaciones Colageno y Magnesio 375gr Package Leaflet |
   16.56 Composition for Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película Package Leaflet |
   16.57 Composition for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
   16.58 Composition for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion Package Leaflet |
   16.59 Composition for BLASTON 1 mg tablets Package Leaflet |
   16.60 Composition for Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes Package Leaflet |
   16.61 Composition for DOLOCATIL 1 g tablets Package Leaflet |
   16.62 Composition for Dovato 50 mg/300 mg film-coated tablets Package Leaflet |
   16.63 Composition for Enbrel 25 mg powder for solution for injection Package Leaflet |
   16.64 Composition for Flucelvax Package Leaflet - preprocessed ES |
   16.65 Composition for Fluenz Tetra nasal spray suspension Package Leaflet |
   16.66 Composition for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet |
   16.67 Composition for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill Package Leaflet |
   16.68 Composition for Humalog Package Leaflet- Preprocessed |
   16.69 Composition for Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) Package Leaflet |
   16.70 Composition for Karvea 75 mg tablet Package Leaflet |
   16.71 Composition for Karvea 75 mg tablet Package Leaflet |
   16.72 Composition for Karvea 75 mg tablet Package Leaflet |
   16.73 Composition for Karvea Package Leaflet PT Preprocessed |
   16.74 Composition for Lipcut Simvastatin 5 mg Tablet Package Leaflet |
   16.75 Composition for MIRTAZAPINA CINFA 30 mg Coated Tablet Package Leaflet |
   16.76 Composition for Natures Plus Spiru-Tein Package Leaflet |
   16.77 Composition for Nurofen 100 mg Chewable Capsules Package Leaflet |
   16.78 Composition for Ogivri 150 mg powder for concentrate for solution for infusion Package Leaflet |
   16.79 Composition for Pentasa Slow Release Tablets 1g Package Leaflet |
   16.80 Composition for Remsima 100 mg powder for concentrate for solution for infusion Package Leaflet |
   16.81 Composition for Skilarence 120 mg gastro-resistant tablets Package Leaflet |
   16.82 Composition for SORIA NATURAL VITAMINA C 36 COMPRIMIDOS Package Leaflet |
   16.83 Composition for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Package Leaflet |
   16.84 Composition for Tegretol 200 mg tablets Package Leaflet |
   16.85 Composition for Xenical 120mg hard capsules Package Leaflet |
   16.86 contraindication |
   16.87 cud-42659cd40ce761bcf6d15bd28423e45f |
   16.88 cud-4fce9d5258f70f7d605059f97c24efa8 |
   16.89 cud-585e364c14debe29f6c6b564138aa400 |
   16.90 cud-7b1263be67675b61a6b6e6f0a5c35389 |
   16.91 cud-a40c2367ed3c1c715eacd432105752a0 |
   16.92 cud-d79af6e660f456c6c7091803d6bd1a92 |
   16.93 Eli Lilly and Company as Manufacturer API |
   16.94 Eli Lilly Nederland B.V. as Marketing authorisation holder |
   16.95 ePI document Bundle for Aquilea Articulaciones Colageno y Magnesio 375gr Package Leaflet for language es |
   16.96 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 |
   16.97 ePI document Bundle for BLASTON 1 mg tablets Package Leaflet for language es |
   16.98 ePI document Bundle for Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes Package Leaflet for language es |
   16.99 ePI document Bundle for DOLOCATIL 1 g tablets Package Leaflet for language en |
   16.100 ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language es |
   16.101 ePI document Bundle for Enbrel 25 mg powder for solution for injection Package Leaflet for language en |
   16.102 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 |
   16.103 ePI document Bundle for Fluenz Tetra nasal spray suspension Package Leaflet for language en |
   16.104 ePI document Bundle for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet for language es |
   16.105 ePI document Bundle for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill Package Leaflet for language en |
   16.106 ePI document Bundle for Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) Package Leaflet for language en |
   16.107 ePI document Bundle for Karvea 75 mg Package Leaflet for language pt |
   16.108 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language en |
   16.109 ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language es |
   16.110 ePI document Bundle for Lipcut Simvastatin 5 mg Tablet Package Leaflet for language en |
   16.111 ePI document Bundle for MIRTAZAPINA CINFA 30 mg Coated Tablet Package Leaflet for language es |
   16.112 ePI document Bundle for Natures Plus Spiru-Tein Package Leaflet for language es |
   16.113 ePI document Bundle for Nurofen 100 mg Chewable Capsules Package Leaflet for language en |
   16.114 ePI document Bundle for Ogivri 150 mg powder for concentrate for solution for infusion Package Leaflet for language en |
   16.115 ePI document Bundle for Pentasa Slow Release Tablets 1g Package Leaflet for language en |
   16.116 ePI document Bundle for Remsima 100 mg powder for concentrate for solution for infusion Package Leaflet for language en |
   16.117 ePI document Bundle for Skilarence 120 mg gastro-resistant tablets Package Leaflet for language en |
   16.118 ePI document Bundle for SORIA NATURAL VITAMINA C 36 COMPRIMIDOS Package Leaflet for language es |
   16.119 ePI document Bundle for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Package Leaflet for language en |
   16.120 ePI document Bundle for Tegretol 200 mg tablets Package Leaflet for language es |
   16.121 ePI document Bundle for Xenical 120mg hard capsules Package Leaflet for language es |
   16.122 European Medicines Agency as Medicines Regulatory Authority |
   16.123 European Medicines Agency as Medicines Regulatory Authority |
   16.124 European Medicines Agency as Medicines Regulatory Authority |
   16.125 European Medicines Agency as Medicines Regulatory Authority |
   16.126 Example of additional support material - BUILTIN PDF |
   16.127 Example of additional support material - Structured Content |
   16.128 Example of additional support material - URL |
   16.129 FERRER INTERNACIONAL, S.A. as Marketing authorisation holder |
   16.130 FERRING S.A.U. as Marketing authorisation holder |
   16.131 Gilead Sciences Ireland UC as Marketing authorisation holder |
   16.132 GLAXO WELLCOME, S.A. as Manufacturer |
   16.133 Ingredient-active A/Darwin/9/2021 (H3N2) |
   16.134 Ingredient-active A/Victoria/4897/2022 |
   16.135 Ingredient-active adalimumab |
   16.136 Ingredient-active ASCORBIC ACID |
   16.137 Ingredient-active B/Austria/1359417/2021 |
   16.138 Ingredient-active B/Phuket/3073/2013 - |
   16.139 Ingredient-active BICTEGRAVIR SODIUM |
   16.140 Ingredient-active Calcium Carbonate |
   16.141 Ingredient-active CARBAMAZEPINE |
   16.142 Ingredient-active cholecalciferol |
   16.143 Ingredient-active CINITAPRIDE |
   16.144 Ingredient-active DIMETHYL FUMARATE |
   16.145 Ingredient-active DOLUTEGRAVIR SODIUM |
   16.146 Ingredient-active Emtricitabine |
   16.147 Ingredient-active Etanercept |
   16.148 Ingredient-active HUMAN TYPE I COLLAGEN |
   16.149 Ingredient-active hydrogenated soybean oil |
   16.150 Ingredient-active Hypericum perforatum L. |
   16.151 Ingredient-active IBUPROFEN |
   16.152 Ingredient-active INFLIXIMAB |
   16.153 Ingredient-active INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE |
   16.154 Ingredient-active INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE |
   16.155 Ingredient-active INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE |
   16.156 Ingredient-active INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE |
   16.157 Ingredient-active Insulin glargine |
   16.158 Ingredient-active Insulin Lispro |
   16.159 Ingredient-active irbesartan |
   16.160 Ingredient-active lactose monohydrate |
   16.161 Ingredient-active lamivudine |
   16.162 Ingredient-active Lixisenatide |
   16.163 Ingredient-active magnesium |
   16.164 Ingredient-active mesalazine |
   16.165 Ingredient-active Mirtazapine |
   16.166 Ingredient-active ORLISTAT |
   16.167 Ingredient-active paracetamol |
   16.168 Ingredient-active SIMVASTATIN |
   16.169 Ingredient-active Sodium |
   16.170 Ingredient-active SOY PROTEIN |
   16.171 Ingredient-active sucrose |
   16.172 Ingredient-active tenofovir alafenamide |
   16.173 Ingredient-active trastuzumab |
   16.174 Ingredient-excipient acmedrug-ing2 |
   16.175 Ingredient-excipient acmedrug-ing3 |
   16.176 Ingredient-excipient Anhydrous citric acid |
   16.177 Ingredient-excipient ANHYDROUS DEXTROSE |
   16.178 Ingredient-excipient Arginine hydrochloride |
   16.179 Ingredient-excipient CARBOXYMETHYLCELLULOSE |
   16.180 Ingredient-excipient Carnauba wax |
   16.181 Ingredient-excipient CITRIC ACID MONOHYDRATE |
   16.182 Ingredient-excipient colloidal hydrophobic silica |
   16.183 Ingredient-excipient CORN STARCH |
   16.184 Ingredient-excipient Croscarmellose sodium |
   16.185 Ingredient-excipient Croscarmellose sodium |
   16.186 Ingredient-excipient Dipotassium phosphate |
   16.187 Ingredient-excipient Disodium phosphate dihydrate |
   16.188 Ingredient-excipient Ethylcellulose |
   16.189 Ingredient-excipient Gelatin (porcine, Type A) |
   16.190 Ingredient-excipient GELATIN, UNSPECIFIED |
   16.191 Ingredient-excipient Glycerol |
   16.192 Ingredient-excipient GLYCEROL 85% [WHO-DD] |
   16.193 Ingredient-excipient Hydrochloric acid |
   16.194 Ingredient-excipient HYDROCHLORIC ACID [IARC] |
   16.195 Ingredient-excipient HYDROXYPROPYL CELLULOSE, UNSPECIFIED |
   16.196 Ingredient-excipient Hypromellose |
   16.197 Ingredient-excipient HYPROMELLOSE, UNSPECIFIED |
   16.198 Ingredient-excipient Lactose Monohydrate |
   16.199 Ingredient-excipient LACTOSE MONOHYDRATE |
   16.200 Ingredient-excipient LECITHIN, SOYBEAN |
   16.201 Ingredient-excipient Macrogol 3000 |
   16.202 Ingredient-excipient macrogol 6000 |
   16.203 Ingredient-excipient MAGNESIUM CHLORIDE |
   16.204 Ingredient-excipient Magnesium stearate |
   16.205 Ingredient-excipient magnesium stearate |
   16.206 Ingredient-excipient magnesium stearate |
   16.207 Ingredient-excipient Magnesium stearate |
   16.208 Ingredient-excipient Magnesium stearate |
   16.209 Ingredient-excipient Magnesium stearate |
   16.210 Ingredient-excipient Magnesium stearate |
   16.211 Ingredient-excipient Magnesium stearate |
   16.212 Ingredient-excipient Magnesium stearate |
   16.213 Ingredient-excipient maltodextrin |
   16.214 Ingredient-excipient mannitol |
   16.215 Ingredient-excipient MANNITOL |
   16.216 Ingredient-excipient Mannitol |
   16.217 Ingredient-excipient Metacresol |
   16.218 Ingredient-excipient Metacresol |
   16.219 Ingredient-excipient Methionine |
   16.220 Ingredient-excipient Microcrystalline cellulose |
   16.221 Ingredient-excipient microcrystalline cellulose |
   16.222 Ingredient-excipient microcrystalline cellulose |
   16.223 Ingredient-excipient Microcrystalline cellulose |
   16.224 Ingredient-excipient Microcrystalline cellulose |
   16.225 Ingredient-excipient MICROCRYSTALLINE CELLULOSE |
   16.226 Ingredient-excipient Monosodium glutamate monohydrate |
   16.227 Ingredient-excipient Polysorbate 80 |
   16.228 Ingredient-excipient POLYSORBATE 80 |
   16.229 Ingredient-excipient Potassium chloride |
   16.230 Ingredient-excipient Potassium dihydrogen phosphate |
   16.231 Ingredient-excipient Potassium dihydrogen phosphate
|
   16.232 Ingredient-excipient povidone |
   16.233 Ingredient-excipient Povidone |
   16.234 Ingredient-excipient POVIDONE, UNSPECIFIED |
   16.235 Ingredient-excipient POVIDONE, UNSPECIFIED |
   16.236 Ingredient-excipient POVIDONE, UNSPECIFIED |
   16.237 Ingredient-excipient saccharin sodium |
   16.238 Ingredient-excipient SILICA, COLLOIDAL ANHYDROUS |
   16.239 Ingredient-excipient SILICA, COLLOIDAL ANHYDROUS |
   16.240 Ingredient-excipient SILICA, COLLOIDAL ANHYDROUS |
   16.241 Ingredient-excipient Silicon dioxide |
   16.242 Ingredient-excipient sodium bicarbonate |
   16.243 Ingredient-excipient Sodium chloride |
   16.244 Ingredient-excipient Sodium chloride |
   16.245 Ingredient-excipient SODIUM CITRATE, UNSPECIFIED FORM |
   16.246 Ingredient-excipient sodium cyclamate |
   16.247 Ingredient-excipient Sodium dihydrogen phosphate monohydrate |
   16.248 Ingredient-excipient Sodium Hydroxide |
   16.249 Ingredient-excipient Sodium hydroxide |
   16.250 Ingredient-excipient SODIUM LAURYL SULFATE |
   16.251 Ingredient-excipient SODIUM PHOSPHATE, DIBASIC, DIHYDRATE |
   16.252 Ingredient-excipient SODIUM PHOSPHATE, DIBASIC, DIHYDRATE |
   16.253 Ingredient-excipient SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE |
   16.254 Ingredient-excipient sodium starch glycolate |
   16.255 Ingredient-excipient SODIUM STARCH GLYCOLATE TYPE A |
   16.256 Ingredient-excipient SORBITOL |
   16.257 Ingredient-excipient STARCH, CORN |
   16.258 Ingredient-excipient STARCH, CORN |
   16.259 Ingredient-excipient STARCH, POTATO |
   16.260 Ingredient-excipient STARCH, POTATO |
   16.261 Ingredient-excipient STERILE WATER FOR INJECTION |
   16.262 Ingredient-excipient STERILE WATER FOR INJECTION |
   16.263 Ingredient-excipient STERILE WATER FOR INJECTION |
   16.264 Ingredient-excipient SUCROSE |
   16.265 Ingredient-excipient Sucrose |
   16.266 Ingredient-excipient Sucrose |
   16.267 Ingredient-excipient Sucrose |
   16.268 Ingredient-excipient Talc |
   16.269 Ingredient-excipient Titanium Dioxide |
   16.270 Ingredient-excipient TITANIUM DIOXIDE |
   16.271 Ingredient-excipient TITANIUM DIOXIDE |
   16.272 Ingredient-excipient Trometamol |
   16.273 Ingredient-excipient TROMETHAMINE |
   16.274 Ingredient-excipient Water for injections |
   16.275 Ingredient-excipient Water for injections |
   16.276 Ingredient-excipient Zinc chloride |
   16.277 Ingredient-excipient Zinc Oxide |
   16.278 LABORATORIOS CINFA, S.A. as Marketing authorisation holder |
   16.279 Laboratorios Farmacéuticos ROVI, S.A. as Marketing authorisation holder |
   16.280 Lacer, S.A. - Boters, 5 as Marketing authorisation holder |
   16.281 Lilly S.A. as Manufacturer |
   16.282 List of Biktarvy Package Leaflets |
   16.283 List of biktarvy Package Leaflets |
   16.284 List of Dovato Package Leaflets |
   16.285 List of Dovato Package Leaflets |
   16.286 List of dovato Package Leaflets |
   16.287 List of enbrel smpc Package Leaflets |
   16.288 List of flucelvax Package Leaflets |
   16.289 List of karvea Package Leaflets |
   16.290 List of xenical Package Leaflets |
   16.291 Manufactured item Aquilea Articulaciones Colageno y Magnesio 375gr |
   16.292 Manufactured item Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion |
   16.293 Manufactured item BLASTON 1 mg tablets |
   16.294 Manufactured item Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes |
   16.295 Manufactured item DOLOCATIL 1 g tablets |
   16.296 Manufactured item Dovato 50 mg/300 mg film-coated tablets |
   16.297 Manufactured item Enbrel 25 mg powder for solution for injection |
   16.298 Manufactured item Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) |
   16.299 Manufactured item Fluenz Tetra nasal spray suspension |
   16.300 Manufactured item HIPÉRICO ARKOPHARMA cápsulas duras |
   16.301 Manufactured item Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill |
   16.302 Manufactured item Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) |
   16.303 Manufactured item Karvea 75 mg tablet |
   16.304 Manufactured item Lipcut Simvastatin 5 mg Tablet |
   16.305 Manufactured item MIRTAZAPINA CINFA 30 mg Coated Tablet |
   16.306 Manufactured item Natures Plus Spiru-Tein |
   16.307 Manufactured item Nurofen 100 mg Chewable Capsules |
   16.308 Manufactured item Ogivri 150 mg powder for concentrate for solution for infusion |
   16.309 Manufactured item Pentasa Slow Release Tablets 1g |
   16.310 Manufactured item Remsima 100 mg powder for concentrate for solution for infusion |
   16.311 Manufactured item Skilarence 120 mg gastro-resistant tablets |
   16.312 Manufactured item SORIA NATURAL VITAMINA C 36 COMPRIMIDOS |
   16.313 Manufactured item Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen |
   16.314 Manufactured item Tegretol 200 mg tablets |
   16.315 Manufactured item Xenical 120mg hard capsules |
   16.316 Medicinal Product Aquilea Articulaciones Colageno y Magnesio 375gr |
   16.317 Medicinal Product Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion |
   16.318 Medicinal Product BLASTON 1 mg tablets |
   16.319 Medicinal Product Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes |
   16.320 Medicinal Product cava 75 mg tablet in blister pack of 28 tablets |
   16.321 Medicinal Product DOLOCATIL 1 g tablets |
   16.322 Medicinal Product Dovato 50 mg/300 mg film-coated tablets |
   16.323 Medicinal Product Enbrel 25 mg powder for solution for injection |
   16.324 Medicinal Product Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) |
   16.325 Medicinal Product Fluenz Tetra nasal spray suspension |
   16.326 Medicinal Product HIPÉRICO ARKOPHARMA cápsulas duras |
   16.327 Medicinal Product Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill |
   16.328 Medicinal Product Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) |
   16.329 Medicinal Product Karvea 75 mg tablet |
   16.330 Medicinal Product Lipcut Simvastatin 5 mg Tablet |
   16.331 Medicinal Product MIRTAZAPINA CINFA 30 mg Coated Tablet |
   16.332 Medicinal Product Natures Plus Spiru-Tein |
   16.333 Medicinal Product Nurofen 100 mg Chewable Capsules |
   16.334 Medicinal Product Ogivri 150 mg powder for concentrate for solution for infusion |
   16.335 Medicinal Product Pentasa Slow Release Tablets 1g |
   16.336 Medicinal Product Remsima 100 mg powder for concentrate for solution for infusion |
   16.337 Medicinal Product Skilarence 120 mg gastro-resistant tablets |
   16.338 Medicinal Product SORIA NATURAL VITAMINA C 36 COMPRIMIDOS |
   16.339 Medicinal Product Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen |
   16.340 Medicinal Product Tegretol 200 mg tablets |
   16.341 Medicinal Product Xenical 120mg hard capsules |
   16.342 MedImmune, UK Limited as Manufacturer |
   16.343 Novartis Farmacéutica, S.A. as Marketing authorisation holder |
   16.344 Packaged Product Definition: Aquilea Articulaciones Colageno y Magnesio 375gr 28 |
   16.345 Packaged Product Definition: Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 30 |
   16.346 Packaged Product Definition: Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 90 |
   16.347 Packaged Product Definition: BLASTON 1 mg tablets 50 |
   16.348 Packaged Product Definition: Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes 30 |
   16.349 Packaged Product Definition: DOLOCATIL 1 g tablets 20 |
   16.350 Packaged Product Definition: Dovato 50 mg/300 mg film-coated tablets 30 |
   16.351 Packaged Product Definition: Enbrel 25 mg powder for solution for injection 28 |
   16.352 Packaged Product Definition: Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1 |
   16.353 Packaged Product Definition: Fluenz Tetra nasal spray suspension 1 |
   16.354 Packaged Product Definition: Fluenz Tetra nasal spray suspension 10 |
   16.355 Packaged Product Definition: HIPÉRICO ARKOPHARMA cápsulas duras 30 |
   16.356 Packaged Product Definition: Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill 5 |
   16.357 Packaged Product Definition: Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) 2 |
   16.358 Packaged Product Definition: Karvea 75 mg tablet 14 |
   16.359 Packaged Product Definition: Karvea 75 mg tablet 28 |
   16.360 Packaged Product Definition: Karvea 75 mg tablet 56 |
   16.361 Packaged Product Definition: Karvea 75 mg tablet 98 |
   16.362 Packaged Product Definition: Lipcut Simvastatin 5 mg Tablet 28 |
   16.363 Packaged Product Definition: MIRTAZAPINA CINFA 30 mg Coated Tablet 30 |
   16.364 Packaged Product Definition: Natures Plus Spiru-Tein nan |
   16.365 Packaged Product Definition: Nurofen 100 mg Chewable Capsules 2 |
   16.366 Packaged Product Definition: Ogivri 150 mg powder for concentrate for solution for infusion 1 |
   16.367 Packaged Product Definition: Pentasa Slow Release Tablets 1g 28 |
   16.368 Packaged Product Definition: Remsima 100 mg powder for concentrate for solution for infusion 1 |
   16.369 Packaged Product Definition: Skilarence 120 mg gastro-resistant tablets 40 |
   16.370 Packaged Product Definition: SORIA NATURAL VITAMINA C 36 COMPRIMIDOS 36 |
   16.371 Packaged Product Definition: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 10 |
   16.372 Packaged Product Definition: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 3 |
   16.373 Packaged Product Definition: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 5 |
   16.374 Packaged Product Definition: Tegretol 200 mg tablets 28 |
   16.375 Packaged Product Definition: Xenical 120mg hard capsules 1 |
   16.376 Pedro Persona Vector - Collection |
   16.377 Persona Dimension - Collection |
   16.378 Persona Dimension - Employment |
   16.379 Persona Dimension - Employment |
   16.380 Persona Dimension - Extrovert/introvert |
   16.381 Persona Dimension - Extrovert/introvert |
   16.382 Persona Dimension - Extrovert/introvert |
   16.383 Persona Dimension - Extrovert/introvert |
   16.384 Persona Dimension - Extrovert/introvert |
   16.385 Persona Dimension - Extrovert/introvert |
   16.386 Persona Dimension - Share info Willingly |
   16.387 Persona Dimension - Share info Willingly |
   16.388 Persona Dimension - WorkLife |
   16.389 Persona Dimension - WorkLife |
   16.390 Pfizer Europe MA EEIG as Marketing authorisation holder |
   16.391 Questionnaire-example |
   16.392 QuestionnaireResponse-example |
   16.393 Reckitt Benckiser Healthcare, Lda. as Marketing authorisation holder |
   16.394 Regulated Authorization for Aquilea Articulaciones Colageno y Magnesio 375gr 0 |
   16.395 Regulated Authorization for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 0 |
   16.396 Regulated Authorization for BLASTON 1 mg tablets 0 |
   16.397 Regulated Authorization for Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes 0 |
   16.398 Regulated Authorization for DOLOCATIL 1 g tablets 0 |
   16.399 Regulated Authorization for Dovato 50 mg/300 mg film-coated tablets 0 |
   16.400 Regulated Authorization for Enbrel 25 mg powder for solution for injection 0 |
   16.401 Regulated Authorization for Flucelvax Tetra - suspension for injection in pre-filled syringe
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 0 |
   16.402 Regulated Authorization for Fluenz Tetra nasal spray suspension 0 |
   16.403 Regulated Authorization for Fluenz Tetra nasal spray suspension 1 |
   16.404 Regulated Authorization for HIPÉRICO ARKOPHARMA cápsulas duras 0 |
   16.405 Regulated Authorization for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill 0 |
   16.406 Regulated Authorization for Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) 0 |
   16.407 Regulated Authorization for Karvea 75 mg tablet 0 |
   16.408 Regulated Authorization for Karvea 75 mg tablet 1 |
   16.409 Regulated Authorization for Karvea 75 mg tablet 2 |
   16.410 Regulated Authorization for Karvea 75 mg tablet 3 |
   16.411 Regulated Authorization for Lipcut Simvastatin 5 mg Tablet 0 |
   16.412 Regulated Authorization for MIRTAZAPINA CINFA 30 mg Coated Tablet 0 |
   16.413 Regulated Authorization for Natures Plus Spiru-Tein 0 |
   16.414 Regulated Authorization for Nurofen 100 mg Chewable Capsules 0 |
   16.415 Regulated Authorization for Ogivri 150 mg powder for concentrate for solution for infusion 0 |
   16.416 Regulated Authorization for Pentasa Slow Release Tablets 1g 0 |
   16.417 Regulated Authorization for Remsima 100 mg powder for concentrate for solution for infusion 0 |
   16.418 Regulated Authorization for Skilarence 120 mg gastro-resistant tablets 0 |
   16.419 Regulated Authorization for SORIA NATURAL VITAMINA C 36 COMPRIMIDOS 0 |
   16.420 Regulated Authorization for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 0 |
   16.421 Regulated Authorization for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 1 |
   16.422 Regulated Authorization for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 2 |
   16.423 Regulated Authorization for Tegretol 200 mg tablets 0 |
   16.424 Regulated Authorization for Xenical 120mg hard capsules 0 |
   16.425 Sandoz A/S as Marketing authorisation holder |
   16.426 Sanofi Winthrop Industrie as Marketing authorisation holder |
   16.427 Sanofi Winthrop Industrie as Manufacturer |
   16.428 Sanofi-Aventis Deutschland GmbH as Manufacturer |
   16.429 Sanofi-Aventis Groupe as Marketing authorisation holder |
   16.430 Seqirus Netherlands B.V. as Marketing authorisation holder |
   16.431 substance-adalimumab |
   16.432 substance-ascorbicacid |
   16.433 substance-calciumcarbonate |
   16.434 substance-carbamazepine |
   16.435 substance-cinitapride |
   16.436 substance-dimethylfumarate |
   16.437 substance-dolutegravirsodium |
   16.438 substance-etanercept |
   16.439 substance-hypericumperforatumwhole |
   16.440 substance-ibuprofen |
   16.441 substance-infliximab |
   16.442 substance-influenzaavirusadarwin112021h3n2whole |
   16.443 substance-influenzaavirusadelaware552019cvr45h1n1whole |
   16.444 substance-influenzabvirusbsingaporeinftt1606102016whole |
   16.445 substance-influenzabvirusbsingaporewuh46182021whole |
   16.446 substance-insulinglargine |
   16.447 substance-insulinlispro |
   16.448 substance-irbesartan |
   16.449 substance-lamivudine |
   16.450 substance-lixisenatide |
   16.451 substance-magnesium |
   16.452 substance-mesalamine |
   16.453 substance-mirtazapine |
   16.454 substance-orlistat |
   16.455 substance-paracetamol |
   16.456 substance-simvastatin |
   16.457 substance-soyprotein |
   16.458 substance-trastuzumab |
   16.459 Viatris Limited as Marketing authorisation holder |
   16.460 ViiV Healthcare BV as Marketing authorisation holder |
   16.461 [Preprocessed] ePI document Bundle for Karvea 75 mg Package Leaflet |
   16.462 [Preprocessed] ePI document for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet |
   16.463 [Preprocessed] ePI document for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet |
   16.464 [Preprocessed] ePI document for Dovato 50 mg/300 mg comprimidos Package Leaflet |
   16.465 [Preprocessed] ePI document for Flucelvax Package Leaflet in ES |
   16.466 [Preprocessed] ePI document for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet |
   16.467 [Processed] ePI document Bundle for biktarvy-es Package Leaflet for language es |
   16.468 [Processed] ePI document Bundle for biktarvy-pt Package Leaflet for language pt |
   16.469 123 |
   16.470 37796 |
   16.471 39664 |
   16.472 40274 |
   16.473 40703 |
   16.474 40963 |
   16.475 Prednisolon "Unimedic" 31,25 mg rektalvæske, opløsning (Bundle) |
   16.476 Hyrimoz 40 mg injektionsvæske, opl. i sprøjte (Bundle) |
   16.477 Hyrimoz 40 mg injektionsvæske, opl. i pen (Bundle) |
   16.478 Humira 40mg/0,4 ml injektionsvæske, opl. i sprøjte (Bundle) |
   16.479 Imurel® 25 mg og 50 mg filmovertrukne tabletter (Bundle) |
   16.480 PENTASA depottabletti 500 mg (Bundle) |
   16.481 PENTASA depottabletti 1 g (Bundle) |
   16.482 Aclasta Sandoz (Bundle) |
   16.483 Actrapid Penfill Novo Nordisk (Bundle) |
   16.484 AeroBec Autohaler Teva (Bundle) |
   16.485 AeroBec Teva (Bundle) |
   16.486 Airomir Autohaler Teva (Bundle) |
   16.487 Alendronat Mylan tabletter 70 mg (Bundle) |
   16.488 Apidra sanofi-aventis ferdigfylt penn, SoloStar (Bundle) |
   16.489 Aprovel Sanofi tabletter 150 mg (Bundle) |
   16.490 Aprovel Sanofi tabletter 300 mg (Bundle) |
   16.491 Asacol Tillotts Pharma enterotabletter (Bundle) |
   16.492 VENTOLINE sumutinliuos 5 mg/ml (Bundle) |
   16.493 VENTOLINE DISKUS inhalaatiojauhe, annosteltu 200 mikrog/annos (Bundle) |
   16.494 STELARA injektioneste, liuos, esitäytetty ruisku 45 mg (Bundle) |
   16.495 STELARA injektioneste, liuos, esitäytetty ruisku 90 mg (Bundle) |
   16.496 REMICADE kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos 100 mg (Bundle) |
   16.497 JANUVIA tabletti, kalvopäällysteinen 25 mg, 50 mg, 100 mg (Bundle) |
   16.498 JANUMET tabletti, kalvopäällysteinen 50/850 mg, 50/1000 mg (Bundle) |
   16.499 GALVUS tabletti 50 mg (Bundle) |
   16.500 Ibrance (palbociclib) tablets - THIS DOCUMENT IS FOR TESTING PURPOSES ONLY. (Bundle) |