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
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-epi-type3-example-wondermox"/>
<language value="en"/>
<type value="document"/>
<timestamp value="2025-12-10T21:36:02.056920"/>
<entry>
<resource>
<Composition>
<id value="composition-wondermox-type3"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type3"/>
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<language value="en"/>
<text>
<status value="generated"/>
<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>
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<status value="final"/>
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<system value="https://spor.ema.europa.eu/v1/lists/100000155531"/>
<code value="100000155538"/>
<display value="Package Leaflet"/>
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<subject>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</subject>
<date value="2025-12-10"/>
<author>
<reference value="Organization/LOC-100009540-KrkaNovoMesto"/>
</author>
<title
value="Package Leaflet: Information for the user - WonderMox 500 mg/125 mg"/>
<section>
<title value="1. What WonderMox is and what it is used for"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029895"/>
<display value="What X is and what it is used for"/>
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</code>
<text>
<status value="additional"/>
<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>
</text>
<entry>
<reference
value="ClinicalUseDefinition/cud-indication-infection"/>
</entry>
<entry>
<reference
value="ClinicalUseDefinition/cud-contra-penicillin-allergy"/>
</entry>
<entry>
<reference
value="ClinicalUseDefinition/cud-interact-methotrexate"/>
</entry>
<entry>
<reference value="ClinicalUseDefinition/cud-warning-hepatic"/>
</entry>
<entry>
<reference value="ClinicalUseDefinition/cud-side-diarrhea"/>
</entry>
<entry>
<reference value="MedicationKnowledge/mk-wondermox"/>
</entry>
</section>
<section>
<title value="2. What you need to know before you take WonderMox"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029896"/>
<display value="What you need to know before you take X"/>
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</code>
<text>
<status value="additional"/>
<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>
</text>
</section>
<section>
<title value="3. How to take WonderMox"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029905"/>
<display value="How to take X"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Always take this medicine exactly as your doctor or pharmacist has told you.</p></div>
</text>
</section>
<section>
<title value="4. Possible side effects"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029906"/>
<display value="Possible side effects"/>
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<text>
<status value="additional"/>
<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>
</text>
</section>
<section>
<title value="5. How to store WonderMox"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029907"/>
<display value="How to store X"/>
</coding>
</code>
<text>
<status value="additional"/>
<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>
</text>
</section>
<section>
<title value="6. Contents of the pack and other information"/>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000029659"/>
<code value="200000029908"/>
<display value="Contents of the pack and other information"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>The active substances are amoxicillin and clavulanic acid.</p></div>
</text>
</section>
</Composition>
</resource>
</entry>
<entry>
<resource>
<MedicinalProductDefinition>
<id value="WonderMox-500mg-125mg-EE-MPD"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:51:48.908+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="http://ema.europa.eu/fhir/mpId"/>
<value value="EE-100009540-30722"/>
</identifier>
<identifier>
<system value="http://ema.europa.eu/fhir/pmsId"/>
<value value="0000000000006"/>
</identifier>
<domain>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000004"/>
<code value="100000000012"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000005003"/>
<code value="200000005004"/>
<display value="Current"/>
</coding>
</status>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072051"/>
<code value="100000072084"/>
<display
value="Medicinal Product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<classification>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
<code value="100000096162"/>
<display value="amoxicillin and beta-lactamase inhibitor"/>
</coding>
</classification>
<classification>
<coding>
<system value="http://www.whocc.no/atc"/>
<code value="J01CR02"/>
<display value="amoxicillin and beta-lactamase inhibitor"/>
</coding>
</classification>
<name>
<productName
value="WonderMox 500 mg/125 mg õhukese polümeerikattega tabletid"/>
<part>
<part value="WonderMox"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="500mg/125mg"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="õhukese polümeerikattega tabletid"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="et"/>
<display value="Estonian"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<resource>
<RegulatedAuthorization>
<id value="WonderMox-500mg-125mg-EE-RA"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:51:49.150+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<value value="879415"/>
</identifier>
<subject>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</subject>
<type>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
<code value="220000000061"/>
<display value="Marketing Authorisation"/>
</coding>
</type>
<region>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</region>
<status>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072049"/>
<code value="200000017708"/>
<display value="Valid - Renewed/Varied"/>
</coding>
</status>
<statusDate value="2021-02-03"/>
<holder>
<reference value="Organization/LOC-100009540-KrkaNovoMesto"/>
</holder>
</RegulatedAuthorization>
</resource>
</entry>
<entry>
<resource>
<PackagedProductDefinition>
<id value="WonderMox-500mg-125mg-EE-PPD-1635117"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:51:50.582+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</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>
</text>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
<value value="EE-100009540-30722-1635117"/>
</identifier>
<packageFor>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="10"/>
<unit value="tablet"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</containedItemQuantity>
<description
value="Ribapakend (Al/Al) 10 õhukese polümeerikattega tabletti karbis"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072083"/>
<display value="Marketed"/>
</coding>
</status>
</marketingStatus>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073559"/>
<display value="Strip"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003200"/>
<display value="Aluminium"/>
</coding>
</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"/>
</reference>
</item>
<amount>
<value value="10"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<resource>
<PackagedProductDefinition>
<id value="WonderMox-500mg-125mg-EE-PPD-1635207"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:51:50.839+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</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>
</text>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
<value value="EE-100009540-30722-1635207"/>
</identifier>
<packageFor>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="500"/>
<unit value="tablet"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</containedItemQuantity>
<description
value="Ribapakend (Al/Al) 500 õhukese polümeerikattega tabletti karbis"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072083"/>
<display value="Marketed"/>
</coding>
</status>
</marketingStatus>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073559"/>
<display value="Strip"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003200"/>
<display value="Aluminium"/>
</coding>
</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"/>
</reference>
</item>
<amount>
<value value="500"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<resource>
<PackagedProductDefinition>
<id value="WonderMox-500mg-125mg-EE-PPD-1635139"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:51:51.081+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</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>
</text>
<identifier>
<system value="http://ema.europa.eu/example/pcid"/>
<value value="EE-100009540-30722-1635139"/>
</identifier>
<packageFor>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</packageFor>
<containedItemQuantity>
<value value="14"/>
<unit value="tablet"/>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</containedItemQuantity>
<description
value="Blisterpakend (OPA/Al/PVC foil/Al foil) 14 õhukese polümeerikattega tabletti karbis"/>
<marketingStatus>
<country>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<code value="100000000388"/>
<display value="Republic of Estonia"/>
</coding>
</country>
<status>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000072052"/>
<code value="100000072083"/>
<display value="Marketed"/>
</coding>
</status>
</marketingStatus>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073498"/>
<display value="Box"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003529"/>
<display value="Cardboard"/>
</coding>
</material>
<packaging>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073346"/>
<code value="100000073496"/>
<display value="Blister"/>
</coding>
</type>
<quantity value="1"/>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003210"/>
<display value="Orientated PolyAmide"/>
</coding>
</material>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003200"/>
<display value="Aluminium"/>
</coding>
</material>
<material>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/200000003199"/>
<code value="200000003222"/>
<display value="PolyVinyl Chloride"/>
</coding>
</material>
<containedItem>
<item>
<reference>
<reference
value="ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"/>
</reference>
</item>
<amount>
<value value="14"/>
</amount>
</containedItem>
</packaging>
</packaging>
</PackagedProductDefinition>
</resource>
</entry>
<entry>
<resource>
<AdministrableProductDefinition>
<id value="WonderMox-500mg-125mg-EE-APD"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:53:25.335+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<status value="active"/>
<formOf>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</formOf>
<administrableDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</administrableDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
<producedFrom>
<reference
value="ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"/>
</producedFrom>
<routeOfAdministration>
<code>
<coding>
<system
value="https://spor.ema.europa.eu/v1/lists/100000073345"/>
<code value="100000073619"/>
<display value="Oral use"/>
</coding>
</code>
</routeOfAdministration>
</AdministrableProductDefinition>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="WonderMox-500mg-125mg-EE-I-100000092629"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:53:25.830+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<status value="active"/>
<for>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</for>
<for>
<reference
value="ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/WonderMox-500mg-125mg-EE-APD"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000092629"/>
<display value="AMOXICILLIN TRIHYDRATE"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="573.892"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000091596"/>
<display value="Amoxicillin"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="500"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<Ingredient>
<id value="WonderMox-500mg-125mg-EE-I-100000093061"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:53:26.087+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<status value="active"/>
<for>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</for>
<for>
<reference
value="ManufacturedItemDefinition/WonderMox-500mg-125mg-EE-MID"/>
</for>
<for>
<reference
value="AdministrableProductDefinition/WonderMox-500mg-125mg-EE-APD"/>
</for>
<role>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/100000072050"/>
<code value="100000072072"/>
<display value="Active"/>
</coding>
</role>
<substance>
<code>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000093061"/>
<display value="POTASSIUM CLAVULANATE"/>
</coding>
</concept>
</code>
<strength>
<presentationRatio>
<numerator>
<value value="151.915"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</presentationRatio>
<referenceStrength>
<substance>
<concept>
<coding>
<system
value="https://spor.ema.europa.eu/v2/SubstanceDefinition"/>
<code value="100000089842"/>
<display value="CLAVULANIC ACID"/>
</coding>
</concept>
</substance>
<strengthRatio>
<numerator>
<value value="125"/>
<unit value="milligram(s)"/>
<system
value="https://spor.ema.europa.eu/v1/lists/100000110633"/>
<code value="100000110655"/>
</numerator>
<denominator>
<value value="1"/>
<unit value="tablet"/>
<system
value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
</denominator>
</strengthRatio>
</referenceStrength>
</strength>
</substance>
</Ingredient>
</resource>
</entry>
<entry>
<resource>
<ManufacturedItemDefinition>
<id value="WonderMox-500mg-125mg-EE-MID"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:51:49.850+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<status value="active"/>
<manufacturedDoseForm>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000004"/>
<code value="100000073665"/>
<display value="Film-coated tablet"/>
</coding>
</manufacturedDoseForm>
<unitOfPresentation>
<coding>
<system value="https://spor.ema.europa.eu/v1/lists/200000000014"/>
<code value="200000002152"/>
<display value="Tablet"/>
</coding>
</unitOfPresentation>
</ManufacturedItemDefinition>
</resource>
</entry>
<entry>
<resource>
<Organization>
<id value="LOC-100009540-KrkaNovoMesto"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-26T10:50:40.787+00:00"/>
<profile
value="http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="https://spor.ema.europa.eu/v1/locations"/>
<value value="LOC-100009540"/>
</identifier>
<identifier>
<system value="https://spor.ema.europa.eu/v1/organisations"/>
<value value="ORG-100000627"/>
</identifier>
<name value="KRKA, d.d., Novo mesto"/>
</Organization>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-indication-infection"/>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<type value="indication"/>
<subject>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</subject>
<indication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="40733004"/>
<display value="Bacterial infectious disease"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</indication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-contra-penicillin-allergy"/>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<type value="contraindication"/>
<subject>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</subject>
<contraindication>
<diseaseSymptomProcedure>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="91936005"/>
<display value="Allergy to penicillin"/>
</coding>
</concept>
</diseaseSymptomProcedure>
</contraindication>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-interact-methotrexate"/>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<type value="interaction"/>
<subject>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</subject>
<interaction>
<interactant>
<itemCodeableConcept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="372567009"/>
<display value="Methotrexate"/>
</coding>
</itemCodeableConcept>
</interactant>
</interaction>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-warning-hepatic"/>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</div></td></tr></table></div>
</text>
<type value="warning"/>
<subject>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</subject>
<warning>
<description
value="Use with caution in patients with hepatic impairment."/>
</warning>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<ClinicalUseDefinition>
<id value="cud-side-diarrhea"/>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<type value="undesirable-effect"/>
<subject>
<reference
value="MedicinalProductDefinition/WonderMox-500mg-125mg-EE-MPD"/>
</subject>
<undesirableEffect>
<symptomConditionEffect>
<concept>
<coding>
<system value="http://snomed.info/sct"/>
<code value="62315008"/>
<display value="Diarrhea"/>
</coding>
</concept>
</symptomConditionEffect>
</undesirableEffect>
</ClinicalUseDefinition>
</resource>
</entry>
<entry>
<resource>
<MedicationKnowledge>
<id value="mk-wondermox"/>
<language value="en"/>
<text>
<status value="generated"/>
<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>
</text>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="777067007"/>
<display value="Amoxicillin + Clavulanic Acid"/>
</coding>
</code>
<status value="active"/>
<indicationGuideline>
<dosingGuideline>
<treatmentIntent>
<coding>
<system value="http://snomed.info/sct"/>
<code value="373808002"/>
<display value="Anti-infective treatment"/>
</coding>
</treatmentIntent>
<dosage>
<dosage>
<text value="One 500 mg/125 mg tablet every 8 hours"/>
</dosage>
</dosage>
</dosingGuideline>
</indicationGuideline>
</MedicationKnowledge>
</resource>
</entry>
</Bundle>
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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