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: EMA example-sections-smpc - XML Representation

Active as of 2022-09-02

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="Examplesmpc"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p>This code system http://spor.ema.europa.eu/v1/example-sections-smpc defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td></tr><tr><td style="white-space:nowrap">3<a name="Examplesmpc-3"> </a></td></tr><tr><td style="white-space:nowrap">4<a name="Examplesmpc-4"> </a></td></tr><tr><td style="white-space:nowrap">8<a name="Examplesmpc-8"> </a></td></tr><tr><td style="white-space:nowrap">9<a name="Examplesmpc-9"> </a></td></tr><tr><td style="white-space:nowrap">32<a name="Examplesmpc-32"> </a></td></tr><tr><td style="white-space:nowrap">47<a name="Examplesmpc-47"> </a></td></tr><tr><td style="white-space:nowrap">55<a name="Examplesmpc-55"> </a></td></tr><tr><td style="white-space:nowrap">56<a name="Examplesmpc-56"> </a></td></tr><tr><td style="white-space:nowrap">57<a name="Examplesmpc-57"> </a></td></tr><tr><td style="white-space:nowrap">58<a name="Examplesmpc-58"> </a></td></tr></table><p><b>Additional Language Displays</b></p><table class="codes"><tr><td><b>Code</b></td><td><b>Greek (el)</b></td><td><b>English (English, en)</b></td><td><b>Norwegian (no)</b></td></tr><tr><td>3</td><td>1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ</td><td></td><td>1. LEGEMIDLETS NAVN</td></tr><tr><td>4</td><td>2. ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ</td><td>2. QUALITATIVE AND QUANTITATIVE COMPOSITION</td><td>2. KVALITATIV OG KVANTITATIV SAMMENSETNING</td></tr><tr><td>8</td><td>3. ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ</td><td>3. PHARMACEUTICAL FORM</td><td>3. LEGEMIDDELFORM</td></tr><tr><td>9</td><td>4. ΚΛΙΝΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ</td><td>4. CLINICAL PARTICULARS</td><td>4. KLINISKE OPPLYSNINGER</td></tr><tr><td>32</td><td>5. ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ</td><td>5. PHARMACOLOGICAL PROPERTIES</td><td>5. FARMAKOLOGISKE EGENSKAPER</td></tr><tr><td>47</td><td>6. ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ</td><td>6. PHARMACEUTICAL PARTICULARS</td><td>6. FARMASØYTISKE OPPLYSNINGER</td></tr><tr><td>55</td><td>7. ΚΑΤΟΧΟΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ</td><td>7. MARKETING AUTHORISATION HOLDER</td><td>7. INNEHAVER AV MARKEDSFØRINGSTILLATELSEN</td></tr><tr><td>56</td><td>8. ΑΡΙΘΜΟΣ(ΟΙ) ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ</td><td>8. MARKETING AUTHORISATION NUMBER(S)</td><td>8. MARKEDSFØRINGSTILLATELSESNUMMER (NUMRE)</td></tr><tr><td>57</td><td>9. ΗΜΕΡΟΜΗΝΙΑ ΠΡΩΤΗΣ ΕΓΚΡΙΣΗΣ/ΑΝΑΝΕΩΣΗΣ ΤΗΣ ΑΔΕΙΑΣ</td><td>9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION</td><td>9. DATO FOR FØRSTE MARKEDSFØRINGSTILLATELSE / SISTE FORNYELSE</td></tr><tr><td>58</td><td>10. ΗΜΕΡΟΜΗΝΙΑ ΑΝΑΘΕΩΡΗΣΗΣ ΤΟΥ ΚΕΙΜΕΝΟΥ</td><td>10. DATE OF REVISION OF THE TEXT</td><td>10. OPPDATERINGSDATO</td></tr></table></div>
  </text>
  <url value="http://spor.ema.europa.eu/v1/example-sections-smpc"/>
  <version value="0.1.0"/>
  <name value="Examplesmpc"/>
  <title value="EMA example-sections-smpc"/>
  <status value="active"/>
  <date value="2022-09-02T12:45:28+00:00"/>
  <contact>
    <name value="Gravitate Health Project"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.gravitatehealth.eu/"/>
    </telecom>
  </contact>
  <description value="Placeholder for EMA example-sections smpc"/>
  <content value="complete"/>
  <count value="10"/>
  <concept>
    <code value="3"/>
    <designation>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="1. NAME OF THE MEDICINAL PRODUCT"/>
    </designation>
    <designation>
      <language value="no"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="1. LEGEMIDLETS NAVN"/>
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      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="1. ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ"/>
    </designation>
  </concept>
  <concept>
    <code value="4"/>
    <designation>
      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION"/>
    </designation>
    <designation>
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      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="2. KVALITATIV OG KVANTITATIV SAMMENSETNING"/>
    </designation>
    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="2. ΠΟΙΟΤΙΚΗ ΚΑΙ ΠΟΣΟΤΙΚΗ ΣΥΝΘΕΣΗ"/>
    </designation>
  </concept>
  <concept>
    <code value="8"/>
    <designation>
      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="3. PHARMACEUTICAL FORM"/>
    </designation>
    <designation>
      <language value="no"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="3. LEGEMIDDELFORM"/>
    </designation>
    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="3. ΦΑΡΜΑΚΟΤΕΧΝΙΚΗ ΜΟΡΦΗ"/>
    </designation>
  </concept>
  <concept>
    <code value="9"/>
    <designation>
      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="4. CLINICAL PARTICULARS"/>
    </designation>
    <designation>
      <language value="no"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="4. KLINISKE OPPLYSNINGER"/>
    </designation>
    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="4. ΚΛΙΝΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ"/>
    </designation>
  </concept>
  <concept>
    <code value="32"/>
    <designation>
      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="5. PHARMACOLOGICAL PROPERTIES"/>
    </designation>
    <designation>
      <language value="no"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="5. FARMAKOLOGISKE EGENSKAPER"/>
    </designation>
    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="5. ΦΑΡΜΑΚΟΛΟΓΙΚΕΣ ΙΔΙΟΤΗΤΕΣ"/>
    </designation>
  </concept>
  <concept>
    <code value="47"/>
    <designation>
      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="6. PHARMACEUTICAL PARTICULARS"/>
    </designation>
    <designation>
      <language value="no"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="6. FARMASØYTISKE OPPLYSNINGER"/>
    </designation>
    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="6. ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ"/>
    </designation>
  </concept>
  <concept>
    <code value="55"/>
    <designation>
      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="7. MARKETING AUTHORISATION HOLDER"/>
    </designation>
    <designation>
      <language value="no"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="7. INNEHAVER AV MARKEDSFØRINGSTILLATELSEN"/>
    </designation>
    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="7. ΚΑΤΟΧΟΣ ΤΗΣ ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ"/>
    </designation>
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    <code value="56"/>
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      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="8. MARKETING AUTHORISATION NUMBER(S)"/>
    </designation>
    <designation>
      <language value="no"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="8. MARKEDSFØRINGSTILLATELSESNUMMER (NUMRE)"/>
    </designation>
    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="8. ΑΡΙΘΜΟΣ(ΟΙ) ΑΔΕΙΑΣ ΚΥΚΛΟΦΟΡΙΑΣ"/>
    </designation>
  </concept>
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    <code value="57"/>
    <designation>
      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION"/>
    </designation>
    <designation>
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      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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             value="9. DATO FOR FØRSTE MARKEDSFØRINGSTILLATELSE / SISTE FORNYELSE"/>
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    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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    </designation>
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  <concept>
    <code value="58"/>
    <designation>
      <language value="en"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="10. DATE OF REVISION OF THE TEXT"/>
    </designation>
    <designation>
      <language value="no"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
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      <value value="10. OPPDATERINGSDATO"/>
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    <designation>
      <language value="el"/>
      <use>
        <system value="http://snomed.info/sct"/>
        <code value="900000000000003001"/>
      </use>
      <value value="10. ΗΜΕΡΟΜΗΝΙΑ ΑΝΑΘΕΩΡΗΣΗΣ ΤΟΥ ΚΕΙΜΕΝΟΥ"/>
    </designation>
  </concept>
</CodeSystem>