Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use
Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "bundle-epi-type3-example-wondermox",
"language" : "en",
"type" : "document",
"timestamp" : "2025-12-10T21:36:02.056920",
"entry" : [
{
"resource" : {
"resourceType" : "Composition",
"id" : "composition-wondermox-type3",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type3"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_composition-wondermox-type3\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-wondermox-type3</b></p><a name=\"composition-wondermox-type3\"> </a><a name=\"hccomposition-wondermox-type3\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <code>http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type3</code></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000155531 100000155538}\">Package Leaflet</span></p><p><b>date</b>: 2025-12-10</p><p><b>author</b>: <a href=\"Bundle-8ca935a2-79e9-445b-a38c-f5ce4253f3f5.html#Organization_LOC-100009540-KrkaNovoMesto\">Organization KRKA, d.d., Novo mesto</a></p><p><b>title</b>: Package Leaflet: Information for the user - WonderMox 500 mg/125 mg</p></div>"
},
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000155531",
"code" : "100000155538",
"display" : "Package Leaflet"
}
]
},
"subject" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"date" : "2025-12-10",
"author" : [
{
"reference" : "Organization/LOC-100009540-KrkaNovoMesto"
}
],
"title" : "Package Leaflet: Information for the user - WonderMox 500 mg/125 mg",
"section" : [
{
"title" : "1. What WonderMox is and what it is used for",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029895",
"display" : "What X is and what it is used for"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>WonderMox is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid.</p></div>"
},
"entry" : [
{
"reference" : "ClinicalUseDefinition/cud-indication-infection"
},
{
"reference" : "ClinicalUseDefinition/cud-contra-penicillin-allergy"
},
{
"reference" : "ClinicalUseDefinition/cud-interact-methotrexate"
},
{
"reference" : "ClinicalUseDefinition/cud-warning-hepatic"
},
{
"reference" : "ClinicalUseDefinition/cud-side-diarrhea"
},
{
"reference" : "MedicationKnowledge/mk-wondermox"
}
]
},
{
"title" : "2. What you need to know before you take WonderMox",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029896",
"display" : "What you need to know before you take X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not take WonderMox if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine.</p></div>"
}
},
{
"title" : "3. How to take WonderMox",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029905",
"display" : "How to take X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Always take this medicine exactly as your doctor or pharmacist has told you.</p></div>"
}
},
{
"title" : "4. Possible side effects",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029906",
"display" : "Possible side effects"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Common side effects may include diarrhea, thrush (candida), feeling sick (nausea) or being sick (vomiting).</p></div>"
}
},
{
"title" : "5. How to store WonderMox",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029907",
"display" : "How to store X"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Keep this medicine out of the sight and reach of children. Store in the original package in order to protect from moisture.</p></div>"
}
},
{
"title" : "6. Contents of the pack and other information",
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000029659",
"code" : "200000029908",
"display" : "Contents of the pack and other information"
}
]
},
"text" : {
"status" : "additional",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The active substances are amoxicillin and clavulanic acid.</p></div>"
}
}
]
}
},
{
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "WonderMox-500mg-125mg-EE-MPD",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:51:48.908+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition WonderMox-500mg-125mg-EE-MPD</b></p><a name=\"WonderMox-500mg-125mg-EE-MPD\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-MPD\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:51:48+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/mpId</code>/EE-100009540-30722, <code>http://ema.europa.eu/fhir/pmsId</code>/0000000000006</p><p><b>domain</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000004 100000000012}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000005003 200000005004}\">Current</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073665}\">Film-coated tablet</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072051 100000072084}\">Medicinal Product subject to medical prescription</span></p><p><b>classification</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000093533 100000096162}\">amoxicillin and beta-lactamase inhibitor</span>, <span title=\"Codes:{http://www.whocc.no/atc J01CR02}\">amoxicillin and beta-lactamase inhibitor</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: WonderMox 500 mg/125 mg õhukese polümeerikattega tabletid</p><blockquote><p><b>part</b></p><p><b>part</b>: WonderMox</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 500mg/125mg</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: õhukese polümeerikattega tabletid</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}\">Republic of Estonia</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 et}\">Estonian</span></td></tr></table></blockquote></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/fhir/mpId",
"value" : "EE-100009540-30722"
},
{
"system" : "http://ema.europa.eu/fhir/pmsId",
"value" : "0000000000006"
}
],
"domain" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000004",
"code" : "100000000012",
"display" : "Human use"
}
]
},
"status" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000005003",
"code" : "200000005004",
"display" : "Current"
}
]
},
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000004",
"code" : "100000073665",
"display" : "Film-coated tablet"
}
]
},
"legalStatusOfSupply" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072051",
"code" : "100000072084",
"display" : "Medicinal Product subject to medical prescription"
}
]
},
"classification" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000093533",
"code" : "100000096162",
"display" : "amoxicillin and beta-lactamase inhibitor"
}
]
},
{
"coding" : [
{
"system" : "http://www.whocc.no/atc",
"code" : "J01CR02",
"display" : "amoxicillin and beta-lactamase inhibitor"
}
]
}
],
"name" : [
{
"productName" : "WonderMox 500 mg/125 mg õhukese polümeerikattega tabletid",
"part" : [
{
"part" : "WonderMox",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000002",
"display" : "Invented name part"
}
]
}
},
{
"part" : "500mg/125mg",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000004",
"display" : "Strength part"
}
]
}
},
{
"part" : "õhukese polümeerikattega tabletid",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/220000000000",
"code" : "220000000005",
"display" : "Pharmaceutical dose form part"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000388",
"display" : "Republic of Estonia"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "et",
"display" : "Estonian"
}
]
}
}
]
}
]
}
},
{
"resource" : {
"resourceType" : "RegulatedAuthorization",
"id" : "WonderMox-500mg-125mg-EE-RA",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:51:49.150+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_WonderMox-500mg-125mg-EE-RA\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization WonderMox-500mg-125mg-EE-RA</b></p><a name=\"WonderMox-500mg-125mg-EE-RA\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-RA\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:51:49+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization</code></p></div><p><b>identifier</b>: 879415</p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/220000000060 220000000061}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}\">Republic of Estonia</span></p><p><b>status</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072049 200000017708}\">Valid - Renewed/Varied</span></p><p><b>statusDate</b>: 2021-02-03</p><p><b>holder</b>: <a href=\"Bundle-8ca935a2-79e9-445b-a38c-f5ce4253f3f5.html#Organization_LOC-100009540-KrkaNovoMesto\">Organization KRKA, d.d., Novo mesto</a></p></div>"
},
"identifier" : [
{
"value" : "879415"
}
],
"subject" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/220000000060",
"code" : "220000000061",
"display" : "Marketing Authorisation"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000388",
"display" : "Republic of Estonia"
}
]
}
],
"status" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072049",
"code" : "200000017708",
"display" : "Valid - Renewed/Varied"
}
]
},
"statusDate" : "2021-02-03",
"holder" : {
"reference" : "Organization/LOC-100009540-KrkaNovoMesto"
}
}
},
{
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "WonderMox-500mg-125mg-EE-PPD-1635117",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:51:50.582+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_WonderMox-500mg-125mg-EE-PPD-1635117\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition WonderMox-500mg-125mg-EE-PPD-1635117</b></p><a name=\"WonderMox-500mg-125mg-EE-PPD-1635117\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-PPD-1635117\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:51:50+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/EE-100009540-30722-1635117</p><p><b>packageFor</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><p><b>containedItemQuantity</b>: 10 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><p><b>description</b>: </p><div><p>Ribapakend (Al/Al) 10 õhukese polümeerikattega tabletti karbis</p>\n</div><h3>MarketingStatuses</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}\">Republic of Estonia</span></td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072083}\">Marketed</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073498}\">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003529}\">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073559}\">Strip</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003200}\">Aluminium</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#ManufacturedItemDefinition_WonderMox-500mg-125mg-EE-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 10</p></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/example/pcid",
"value" : "EE-100009540-30722-1635117"
}
],
"packageFor" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"containedItemQuantity" : [
{
"value" : 10,
"unit" : "tablet",
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152"
}
],
"description" : "Ribapakend (Al/Al) 10 õhukese polümeerikattega tabletti karbis",
"marketingStatus" : [
{
"country" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000388",
"display" : "Republic of Estonia"
}
]
},
"status" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072052",
"code" : "100000072083",
"display" : "Marketed"
}
]
}
}
],
"packaging" : {
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"code" : "100000073498",
"display" : "Box"
}
]
},
"quantity" : 1,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003529",
"display" : "Cardboard"
}
]
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"code" : "100000073559",
"display" : "Strip"
}
]
},
"quantity" : 1,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003200",
"display" : "Aluminium"
}
]
}
],
"containedItem" : [
{
"item" : {
"reference" : {
"reference" : "ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"
}
},
"amount" : {
"value" : 10
}
}
]
}
]
}
}
},
{
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "WonderMox-500mg-125mg-EE-PPD-1635207",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:51:50.839+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_WonderMox-500mg-125mg-EE-PPD-1635207\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition WonderMox-500mg-125mg-EE-PPD-1635207</b></p><a name=\"WonderMox-500mg-125mg-EE-PPD-1635207\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-PPD-1635207\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:51:50+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/EE-100009540-30722-1635207</p><p><b>packageFor</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><p><b>containedItemQuantity</b>: 500 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><p><b>description</b>: </p><div><p>Ribapakend (Al/Al) 500 õhukese polümeerikattega tabletti karbis</p>\n</div><h3>MarketingStatuses</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}\">Republic of Estonia</span></td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072083}\">Marketed</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073498}\">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003529}\">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073559}\">Strip</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003200}\">Aluminium</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#ManufacturedItemDefinition_WonderMox-500mg-125mg-EE-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 500</p></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/example/pcid",
"value" : "EE-100009540-30722-1635207"
}
],
"packageFor" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"containedItemQuantity" : [
{
"value" : 500,
"unit" : "tablet",
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152"
}
],
"description" : "Ribapakend (Al/Al) 500 õhukese polümeerikattega tabletti karbis",
"marketingStatus" : [
{
"country" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000388",
"display" : "Republic of Estonia"
}
]
},
"status" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072052",
"code" : "100000072083",
"display" : "Marketed"
}
]
}
}
],
"packaging" : {
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"code" : "100000073498",
"display" : "Box"
}
]
},
"quantity" : 1,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003529",
"display" : "Cardboard"
}
]
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"code" : "100000073559",
"display" : "Strip"
}
]
},
"quantity" : 1,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003200",
"display" : "Aluminium"
}
]
}
],
"containedItem" : [
{
"item" : {
"reference" : {
"reference" : "ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"
}
},
"amount" : {
"value" : 500
}
}
]
}
]
}
}
},
{
"resource" : {
"resourceType" : "PackagedProductDefinition",
"id" : "WonderMox-500mg-125mg-EE-PPD-1635139",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:51:51.081+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PackagedProductDefinition_WonderMox-500mg-125mg-EE-PPD-1635139\"> </a><p class=\"res-header-id\"><b>Generated Narrative: PackagedProductDefinition WonderMox-500mg-125mg-EE-PPD-1635139</b></p><a name=\"WonderMox-500mg-125mg-EE-PPD-1635139\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-PPD-1635139\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:51:51+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition</code></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/example/pcid</code>/EE-100009540-30722-1635139</p><p><b>packageFor</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><p><b>containedItemQuantity</b>: 14 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><p><b>description</b>: </p><div><p>Blisterpakend (OPA/Al/PVC foil/Al foil) 14 õhukese polümeerikattega tabletti karbis</p>\n</div><h3>MarketingStatuses</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Status</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000000002 100000000388}\">Republic of Estonia</span></td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072052 100000072083}\">Marketed</span></td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073498}\">Box</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003529}\">Cardboard</span></p><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073346 100000073496}\">Blister</span></p><p><b>quantity</b>: 1</p><p><b>material</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003210}\">Orientated PolyAmide</span>, <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003200}\">Aluminium</span>, <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000003199 200000003222}\">PolyVinyl Chloride</span></p><blockquote><p><b>containedItem</b></p><h3>Items</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#ManufacturedItemDefinition_WonderMox-500mg-125mg-EE-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></td></tr></table><p><b>amount</b>: 14</p></blockquote></blockquote></blockquote></div>"
},
"identifier" : [
{
"system" : "http://ema.europa.eu/example/pcid",
"value" : "EE-100009540-30722-1635139"
}
],
"packageFor" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"containedItemQuantity" : [
{
"value" : 14,
"unit" : "tablet",
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152"
}
],
"description" : "Blisterpakend (OPA/Al/PVC foil/Al foil) 14 õhukese polümeerikattega tabletti karbis",
"marketingStatus" : [
{
"country" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000000002",
"code" : "100000000388",
"display" : "Republic of Estonia"
}
]
},
"status" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072052",
"code" : "100000072083",
"display" : "Marketed"
}
]
}
}
],
"packaging" : {
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"code" : "100000073498",
"display" : "Box"
}
]
},
"quantity" : 1,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003529",
"display" : "Cardboard"
}
]
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073346",
"code" : "100000073496",
"display" : "Blister"
}
]
},
"quantity" : 1,
"material" : [
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003210",
"display" : "Orientated PolyAmide"
}
]
},
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003200",
"display" : "Aluminium"
}
]
},
{
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000003199",
"code" : "200000003222",
"display" : "PolyVinyl Chloride"
}
]
}
],
"containedItem" : [
{
"item" : {
"reference" : {
"reference" : "ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"
}
},
"amount" : {
"value" : 14
}
}
]
}
]
}
}
},
{
"resource" : {
"resourceType" : "AdministrableProductDefinition",
"id" : "WonderMox-500mg-125mg-EE-APD",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:53:25.335+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_WonderMox-500mg-125mg-EE-APD\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition WonderMox-500mg-125mg-EE-APD</b></p><a name=\"WonderMox-500mg-125mg-EE-APD\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-APD\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:53:25+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition</code></p></div><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073665}\">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002152}\">Tablet</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#ManufacturedItemDefinition_WonderMox-500mg-125mg-EE-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></p><h3>RouteOfAdministrations</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000073345 100000073619}\">Oral use</span></td></tr></table></div>"
},
"status" : "active",
"formOf" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"administrableDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000004",
"code" : "100000073665",
"display" : "Film-coated tablet"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152",
"display" : "Tablet"
}
]
},
"producedFrom" : [
{
"reference" : "ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"
}
],
"routeOfAdministration" : [
{
"code" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000073345",
"code" : "100000073619",
"display" : "Oral use"
}
]
}
}
]
}
},
{
"resource" : {
"resourceType" : "Ingredient",
"id" : "WonderMox-500mg-125mg-EE-I-100000092629",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:53:25.830+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_WonderMox-500mg-125mg-EE-I-100000092629\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient WonderMox-500mg-125mg-EE-I-100000092629</b></p><a name=\"WonderMox-500mg-125mg-EE-I-100000092629\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-I-100000092629\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:53:25+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient</code></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></li><li><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#ManufacturedItemDefinition_WonderMox-500mg-125mg-EE-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#AdministrableProductDefinition_WonderMox-500mg-125mg-EE-APD\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072072}\">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v2/SubstanceDefinition 100000092629}\">AMOXICILLIN TRIHYDRATE</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 573.892 milligram(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v2/SubstanceDefinition 100000091596}\">Amoxicillin</span></td></tr></table><p><b>strength</b>: 500 milligram(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: 200000000014 code200000002152 = '200000002152')</span></p></blockquote></blockquote></blockquote></div>"
},
"status" : "active",
"for" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
},
{
"reference" : "ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"
},
{
"reference" : "AdministrableProductDefinition/WonderMox-500mg-125mg-EE-APD"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072050",
"code" : "100000072072",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v2/SubstanceDefinition",
"code" : "100000092629",
"display" : "AMOXICILLIN TRIHYDRATE"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 573.892,
"unit" : "milligram(s)",
"system" : "https://spor.ema.europa.eu/v1/lists/100000110633",
"code" : "100000110655"
},
"denominator" : {
"value" : 1,
"unit" : "tablet",
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152"
}
},
"referenceStrength" : [
{
"substance" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v2/SubstanceDefinition",
"code" : "100000091596",
"display" : "Amoxicillin"
}
]
}
},
"strengthRatio" : {
"numerator" : {
"value" : 500,
"unit" : "milligram(s)",
"system" : "https://spor.ema.europa.eu/v1/lists/100000110633",
"code" : "100000110655"
},
"denominator" : {
"value" : 1,
"unit" : "tablet",
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152"
}
}
}
]
}
]
}
}
},
{
"resource" : {
"resourceType" : "Ingredient",
"id" : "WonderMox-500mg-125mg-EE-I-100000093061",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:53:26.087+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_WonderMox-500mg-125mg-EE-I-100000093061\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient WonderMox-500mg-125mg-EE-I-100000093061</b></p><a name=\"WonderMox-500mg-125mg-EE-I-100000093061\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-I-100000093061\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:53:26+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient</code></p></div><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></li><li><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#ManufacturedItemDefinition_WonderMox-500mg-125mg-EE-MID\">ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li><li><a href=\"Bundle-bundle-epi-type2-example-wondermox.html#AdministrableProductDefinition_WonderMox-500mg-125mg-EE-APD\">AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/100000072050 100000072072}\">Active</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v2/SubstanceDefinition 100000093061}\">POTASSIUM CLAVULANATE</span></td></tr></table><blockquote><p><b>strength</b></p><p><b>presentation</b>: 151.915 milligram(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: 200000000014 code200000002152 = '200000002152')</span></p><blockquote><p><b>referenceStrength</b></p><h3>Substances</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/v2/SubstanceDefinition 100000089842}\">CLAVULANIC ACID</span></td></tr></table><p><b>strength</b>: 125 milligram(s)<span style=\"background: LightGoldenRodYellow\"> (Details: 100000110633 code100000110655 = '100000110655')</span>/1 tablet<span style=\"background: LightGoldenRodYellow\"> (Details: 200000000014 code200000002152 = '200000002152')</span></p></blockquote></blockquote></blockquote></div>"
},
"status" : "active",
"for" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
},
{
"reference" : "ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"
},
{
"reference" : "AdministrableProductDefinition/WonderMox-500mg-125mg-EE-APD"
}
],
"role" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/100000072050",
"code" : "100000072072",
"display" : "Active"
}
]
},
"substance" : {
"code" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v2/SubstanceDefinition",
"code" : "100000093061",
"display" : "POTASSIUM CLAVULANATE"
}
]
}
},
"strength" : [
{
"presentationRatio" : {
"numerator" : {
"value" : 151.915,
"unit" : "milligram(s)",
"system" : "https://spor.ema.europa.eu/v1/lists/100000110633",
"code" : "100000110655"
},
"denominator" : {
"value" : 1,
"unit" : "tablet",
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152"
}
},
"referenceStrength" : [
{
"substance" : {
"concept" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v2/SubstanceDefinition",
"code" : "100000089842",
"display" : "CLAVULANIC ACID"
}
]
}
},
"strengthRatio" : {
"numerator" : {
"value" : 125,
"unit" : "milligram(s)",
"system" : "https://spor.ema.europa.eu/v1/lists/100000110633",
"code" : "100000110655"
},
"denominator" : {
"value" : 1,
"unit" : "tablet",
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152"
}
}
}
]
}
]
}
}
},
{
"resource" : {
"resourceType" : "ManufacturedItemDefinition",
"id" : "WonderMox-500mg-125mg-EE-MID",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:51:49.850+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_WonderMox-500mg-125mg-EE-MID\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition WonderMox-500mg-125mg-EE-MID</b></p><a name=\"WonderMox-500mg-125mg-EE-MID\"> </a><a name=\"hcWonderMox-500mg-125mg-EE-MID\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:51:49+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition</code></p></div><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000004 100000073665}\">Film-coated tablet</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/v1/lists/200000000014 200000002152}\">Tablet</span></p></div>"
},
"status" : "active",
"manufacturedDoseForm" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000004",
"code" : "100000073665",
"display" : "Film-coated tablet"
}
]
},
"unitOfPresentation" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/v1/lists/200000000014",
"code" : "200000002152",
"display" : "Tablet"
}
]
}
}
},
{
"resource" : {
"resourceType" : "Organization",
"id" : "LOC-100009540-KrkaNovoMesto",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-26T10:50:40.787+00:00",
"profile" : [
"http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"
]
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_LOC-100009540-KrkaNovoMesto\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization LOC-100009540-KrkaNovoMesto</b></p><a name=\"LOC-100009540-KrkaNovoMesto\"> </a><a name=\"hcLOC-100009540-KrkaNovoMesto\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-11-26 10:50:40+0000</p><p style=\"margin-bottom: 0px\">Profile: <code>http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization</code></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/v1/locations</code>/LOC-100009540, <code>https://spor.ema.europa.eu/v1/organisations</code>/ORG-100000627</p><p><b>name</b>: KRKA, d.d., Novo mesto</p></div>"
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/v1/locations",
"value" : "LOC-100009540"
},
{
"system" : "https://spor.ema.europa.eu/v1/organisations",
"value" : "ORG-100000627"
}
],
"name" : "KRKA, d.d., Novo mesto"
}
},
{
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "cud-indication-infection",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-indication-infection\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-indication-infection</b></p><a name=\"cud-indication-infection\"> </a><a name=\"hccud-indication-infection\"> </a><p><b>type</b>: Indication</p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><blockquote><p><b>indication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 40733004}\">Bacterial infectious disease</span></td></tr></table></blockquote></div>"
},
"type" : "indication",
"subject" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"indication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "40733004",
"display" : "Bacterial infectious disease"
}
]
}
}
}
}
},
{
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "cud-contra-penicillin-allergy",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-contra-penicillin-allergy\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-contra-penicillin-allergy</b></p><a name=\"cud-contra-penicillin-allergy\"> </a><a name=\"hccud-contra-penicillin-allergy\"> </a><p><b>type</b>: Contraindication</p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><blockquote><p><b>contraindication</b></p><h3>DiseaseSymptomProcedures</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 91936005}\">Allergy to penicillin</span></td></tr></table></blockquote></div>"
},
"type" : "contraindication",
"subject" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"contraindication" : {
"diseaseSymptomProcedure" : {
"concept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "91936005",
"display" : "Allergy to penicillin"
}
]
}
}
}
}
},
{
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "cud-interact-methotrexate",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-interact-methotrexate\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-interact-methotrexate</b></p><a name=\"cud-interact-methotrexate\"> </a><a name=\"hccud-interact-methotrexate\"> </a><p><b>type</b>: Interaction</p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><blockquote><p><b>interaction</b></p><h3>Interactants</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 372567009}\">Methotrexate</span></td></tr></table></blockquote></div>"
},
"type" : "interaction",
"subject" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"interaction" : {
"interactant" : [
{
"itemCodeableConcept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "372567009",
"display" : "Methotrexate"
}
]
}
}
]
}
}
},
{
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "cud-warning-hepatic",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-warning-hepatic\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-warning-hepatic</b></p><a name=\"cud-warning-hepatic\"> </a><a name=\"hccud-warning-hepatic\"> </a><p><b>type</b>: Warning</p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><h3>Warnings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Description</b></td></tr><tr><td style=\"display: none\">*</td><td><div><p>Use with caution in patients with hepatic impairment.</p>\n</div></td></tr></table></div>"
},
"type" : "warning",
"subject" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"warning" : {
"description" : "Use with caution in patients with hepatic impairment."
}
}
},
{
"resource" : {
"resourceType" : "ClinicalUseDefinition",
"id" : "cud-side-diarrhea",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ClinicalUseDefinition_cud-side-diarrhea\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ClinicalUseDefinition cud-side-diarrhea</b></p><a name=\"cud-side-diarrhea\"> </a><a name=\"hccud-side-diarrhea\"> </a><p><b>type</b>: Undesirable Effect</p><p><b>subject</b>: <a href=\"Bundle-bundle-epi-type2-example-wondermox.html#MedicinalProductDefinition_WonderMox-500mg-125mg-EE-MPD\">MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor</a></p><blockquote><p><b>undesirableEffect</b></p><h3>SymptomConditionEffects</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://snomed.info/sct 62315008}\">Diarrhea</span></td></tr></table></blockquote></div>"
},
"type" : "undesirable-effect",
"subject" : [
{
"reference" : "MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"
}
],
"undesirableEffect" : {
"symptomConditionEffect" : {
"concept" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "62315008",
"display" : "Diarrhea"
}
]
}
}
}
}
},
{
"resource" : {
"resourceType" : "MedicationKnowledge",
"id" : "mk-wondermox",
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicationKnowledge_mk-wondermox\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicationKnowledge mk-wondermox</b></p><a name=\"mk-wondermox\"> </a><a name=\"hcmk-wondermox\"> </a><p><b>code</b>: <span title=\"Codes:{http://snomed.info/sct 777067007}\">Amoxicillin + Clavulanic Acid</span></p><p><b>status</b>: Active</p><blockquote><p><b>indicationGuideline</b></p><blockquote><p><b>dosingGuideline</b></p><p><b>treatmentIntent</b>: <span title=\"Codes:{http://snomed.info/sct 373808002}\">Anti-infective treatment</span></p><blockquote><p><b>dosage</b></p><h3>Dosages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Text</b></td></tr><tr><td style=\"display: none\">*</td><td>One 500 mg/125 mg tablet every 8 hours</td></tr></table></blockquote></blockquote></blockquote></div>"
},
"code" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "777067007",
"display" : "Amoxicillin + Clavulanic Acid"
}
]
},
"status" : "active",
"indicationGuideline" : [
{
"dosingGuideline" : [
{
"treatmentIntent" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "373808002",
"display" : "Anti-infective treatment"
}
]
},
"dosage" : [
{
"dosage" : [
{
"text" : "One 500 mg/125 mg tablet every 8 hours"
}
]
}
]
}
]
}
]
}
}
]
}
IG © 2022+ HL7 International - Biomedical Research & Regulation Work Group.
Package hl7.fhir.uv.emedicinal-product-info#1.1.0 based on FHIR 5.0.0.
Generated
2026-01-02
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