Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions

: Bundle Japan JA - Package Insert for Tegretol (carbamazepine) 200 mg for tablet - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="bundlejpicarbamazepine200"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
  </meta>
  <language value="ja"/>
  <identifier>
    <system value="https://www.pmda.jp/"/>
    <value value="jpiplaceholder"/>
  </identifier>
  <type value="document"/>
  <timestamp value="2002-08-01T13:28:17Z"/>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Composition/carbamazepine200jpi"/>
    <resource>
      <Composition>
        <id value="carbamazepine200jpi"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
        </meta>
        <language value="ja"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="ja" lang="ja"><a name="Composition_carbamazepine200jpi"> </a><p class="res-header-id"><b>Generated Narrative: Composition carbamazepine200jpi</b></p><a name="carbamazepine200jpi"> </a><a name="hccarbamazepine200jpi"> </a><a name="carbamazepine200jpi-en-US"> </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">Language: ja</p><p style="margin-bottom: 0px">Profile: <a href="https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://spor.ema.europa.eu/rmswi/</code>/fcats34placeholder</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/ 100000155538}">Package Leaflet</span></p><p><b>date</b>: 2002-08-01 13:28:17+0000</p><p><b>author</b>: <a href="Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><p><b>title</b>: Tegretol (carbamazepine) 200 mg for tablet</p><h3>Attesters</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/composition-attestation-mode official}">Official</span></td><td>2002-08-01 13:28:17+0000</td></tr></table></div>
        </text>
        <identifier>
          <system value="https://spor.ema.europa.eu/rmswi/"/>
          <value value="fcats34placeholder"/>
        </identifier>
        <status value="final"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/"/>
            <code value="100000155538"/>
          </coding>
          <text value="Package Leaflet"/>
        </type>
        <subject>
          <reference
                     value="MedicinalProductDefinition/medprodcarbamazepine200"/>
        </subject>
        <date value="2002-08-01T13:28:17Z"/>
        <author>
          <reference value="Organization/orgfujinaga"/>
        </author>
        <title value="Tegretol (carbamazepine) 200 mg for tablet"/>
        <attester>
          <mode>
            <coding>
              <system
                      value="http://hl7.org/fhir/composition-attestation-mode"/>
              <code value="official"/>
            </coding>
          </mode>
          <time value="2002-08-01T13:28:17Z"/>
        </attester>
        <section>
          <title value="アロマターゼ阻害剤/閉経後乳癌治療剤"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="0"/>
            </coding>
            <text value="アロマターゼ阻害剤/閉経後乳癌治療剤"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
        </section>
        <section>
          <title value="1. 警告"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="1"/>
            </coding>
            <text value="1. 警告"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="1.1"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="2.1"/>
              </coding>
              <text value="1.1"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="1.2"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="2.1"/>
              </coding>
              <text value="1.2"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="1.3"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="2.1"/>
              </coding>
              <text value="1.3"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="2. 禁忌(次の患者には投与しないこと)"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="2"/>
            </coding>
            <text value="禁忌(次の患者には投与しないこと)"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="2.1"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="2.1"/>
              </coding>
              <text value="2.1"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="2.2"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="2.2"/>
              </coding>
              <text value="2.2"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="2.3"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="2.3"/>
              </coding>
              <text value="2.3"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="3. 組成・性状"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="3"/>
            </coding>
            <text value="3. 組成・性状"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="3.1 組成"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="3.1"/>
              </coding>
              <text value="3.1 組成"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="3.2 製剤の性状"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="3.2"/>
              </coding>
              <text value="3.2 製剤の性状"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="4. 効能又は効果"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="4"/>
            </coding>
            <text value="効能又は効果"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
        </section>
        <section>
          <title value="5. 効能又は効果に関連する注意"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="5"/>
            </coding>
            <text value="効能又は効果に関連する注意"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
        </section>
        <section>
          <title value="6. 用法及び用量"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="6"/>
            </coding>
            <text value="用法及び用量"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
        </section>
        <section>
          <title value="7. 用法及び用量に関連する注意"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="7"/>
            </coding>
            <text value="7. 用法及び用量に関連する注意"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
        </section>
        <section>
          <title value="8. 重要な基本的注意"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="8"/>
            </coding>
            <text value="重要な基本的注意"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="8.1"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="8.1"/>
              </coding>
              <text value="8.1"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="8.2"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="8.2"/>
              </coding>
              <text value="8.2"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="8.3"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="8.3"/>
              </coding>
              <text value="8.3"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="8.4"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="8.4"/>
              </coding>
              <text value="8.4"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="9. 特定の背景を有する患者に関する注意"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="9"/>
            </coding>
            <text value="特定の背景を有する患者に関する注意"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="9.1"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="9.2"/>
              </coding>
              <text value="9.1"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="9.2 腎機能障害患者"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="9.2"/>
              </coding>
              <text value="9.2 腎機能障害患者"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
            <section>
              <title value="9.2.1 重度の腎障害のある患者"/>
              <code>
                <coding>
                  <system value="https://pmda.jp/"/>
                  <code value="9"/>
                </coding>
                <text value="9.2.1 重度の腎障害のある患者"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
              </text>
            </section>
          </section>
          <section>
            <title value="9.3 肝機能障害患者"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="9.3"/>
              </coding>
              <text value="9.3 肝機能障害患者"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
            <section>
              <title value="9.3.1 重度の肝障害のある患者"/>
              <code>
                <coding>
                  <system value="https://pmda.jp/"/>
                  <code value="9.3.1"/>
                </coding>
                <text value="9.3.1 重度の肝障害のある患者"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
              </text>
            </section>
          </section>
          <section>
            <title value="9.4"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="9.4"/>
              </coding>
              <text value="9.4"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="9.5 妊婦"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="9"/>
              </coding>
              <text value="9.5 妊婦"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="9.6 授乳婦"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="9.6"/>
              </coding>
              <text value="9.6 授乳婦"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="10. 相互作用"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="10"/>
            </coding>
            <text value="10. 相互作用"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="10.1"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="9"/>
              </coding>
              <text value="10.1"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="10.2 併用注意(併用に注意すること)"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="10"/>
              </coding>
              <text value="10.2 併用注意(併用に注意すること)"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="11. 副作用"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="11"/>
            </coding>
            <text value="11. 副作用"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="11.1 重大な副作用"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="11.1"/>
              </coding>
              <text value="11.1 重大な副作用"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
            <section>
              <title value="11.1.1"/>
              <code>
                <coding>
                  <system value="https://pmda.jp/"/>
                  <code value="11.1.1"/>
                </coding>
                <text value="11.1.1"/>
              </code>
              <text>
                <status value="additional"/>
                <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
              </text>
            </section>
          </section>
          <section>
            <title value="11.2 その他の副作用"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="11.2"/>
              </coding>
              <text value="11.2 その他の副作用"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="12. 臨床検査結果に及ぼす影響"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="12"/>
            </coding>
            <text value="12. 臨床検査結果に及ぼす影響"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
        </section>
        <section>
          <title value="13. 過量投与"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="13"/>
            </coding>
            <text value="13. 過量投与"/>
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          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
        </section>
        <section>
          <title value="14. 適用上の注意"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="14"/>
            </coding>
            <text value="14. 適用上の注意"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="14.1 薬剤交付時の注意"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="14.1"/>
              </coding>
              <text value="14.1 薬剤交付時の注意"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="15. その他の注意"/>
          <code>
            <coding>
              <system value="https://pmda.jp/"/>
              <code value="13"/>
            </coding>
            <text value="15. その他の注意"/>
          </code>
          <text>
            <status value="additional"/>
            <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
          </text>
          <section>
            <title value="15.1"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="13"/>
              </coding>
              <text value="15.1"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="15.2 非臨床試験に基づく情報"/>
            <code>
              <coding>
                <system value="https://pmda.jp/"/>
                <code value="13"/>
              </coding>
              <text value="15.2 非臨床試験に基づく情報"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
        </section>
        <section>
          <title value="16. 薬物動態"/>
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            <coding>
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              <code value="13"/>
            </coding>
            <text value="16. 薬物動態"/>
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          <text>
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          </text>
          <section>
            <title value="16.1 血中濃度"/>
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              <coding>
                <system value="https://pmda.jp/"/>
                <code value="13"/>
              </coding>
              <text value="16.1 血中濃度"/>
            </code>
            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
          </section>
          <section>
            <title value="16.2 吸収"/>
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              <text value="16.2 吸収"/>
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            <text>
              <status value="additional"/>
              <div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
            </text>
            <section>
              <title value="16.2.1 食事の影響"/>
              <code>
                <coding>
                  <system value="https://pmda.jp/"/>
                  <code value="13"/>
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        <identifier>
          <system value="http://iyaku.info/medicine"/>
          <value value="1139002F1070"/>
        </identifier>
        <type>
          <coding>
            <system value="http://hl7.org/fhir/medicinal-product-type"/>
            <code value="MedicinalProduct"/>
            <display value="Medicinal Product"/>
          </coding>
        </type>
        <domain>
          <coding>
            <system value="http://hl7.org/fhir/medicinal-product-domain"/>
            <code value="Human"/>
            <display value="Human use"/>
          </coding>
        </domain>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="active"/>
          </coding>
        </status>
        <legalStatusOfSupply>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072084"/>
            <display
                     value="Medicinal product subject to medical prescription"/>
          </coding>
        </legalStatusOfSupply>
        <name>
          <productName value="Tegretol (carbamazepine) 200 mg for tablet"/>
          <type>
            <coding>
              <system value="https://spor.ema.europa.eu/lists/220000000000"/>
              <code value="220000000001"/>
            </coding>
            <text value="Full name"/>
          </type>
          <part>
            <part value="Tegretol"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000002"/>
              </coding>
              <text value="Invented name part"/>
            </type>
          </part>
          <part>
            <part value="carbamazepine"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000003"/>
              </coding>
              <text value="Scientific name part"/>
            </type>
          </part>
          <part>
            <part value="200 mg"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000004"/>
              </coding>
              <text value="Strength part"/>
            </type>
          </part>
          <part>
            <part value="tablet"/>
            <type>
              <coding>
                <system
                        value="https://spor.ema.europa.eu/lists/220000000000"/>
                <code value="220000000005"/>
              </coding>
              <text value="Pharmaceutical dose form part"/>
            </type>
          </part>
          <usage>
            <country>
              <coding>
                <system value="urn:iso:std:iso:3166"/>
                <code value="JP"/>
              </coding>
            </country>
            <jurisdiction>
              <coding>
                <system value="urn:iso:std:iso:3166"/>
                <code value="JP"/>
              </coding>
            </jurisdiction>
            <language>
              <coding>
                <system value="urn:ietf:bcp:47"/>
                <code value="ja-JP"/>
              </coding>
            </language>
          </usage>
        </name>
      </MedicinalProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/packcarbamazepine200"/>
    <resource>
      <PackagedProductDefinition>
        <id value="packcarbamazepine200"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_packcarbamazepine200"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition packcarbamazepine200</b></p><a name="packcarbamazepine200"> </a><a name="hcpackcarbamazepine200"> </a><a name="packcarbamazepine200-en-US"> </a><p><b>identifier</b>: <code>https://pmda-packinsertno/</code>/placeholder2 (use: official, )</p><p><b>name</b>: Tegretol (carbamazepine) 200 mg for tablet in bottles</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000155527}">Chemical Medininal Prodcut</span></p><p><b>packageFor</b>: <a href="Bundle-bundlejpicarbamazepine200.html#MedicinalProductDefinition_medprodcarbamazepine200">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2002-08-01 13:28:17+0000</p><p><b>containedItemQuantity</b>: 200 mg</p><p><b>manufacturer</b>: <a href="Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><h3>Packagings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Quantity</b></td><td><b>Material</b></td></tr><tr><td style="display: none">*</td><td><code>https://spor.ema.europa.eu/pmswi</code>/123456</td><td><span title="Codes:{https://spor.ema.europa.eu/rmswi 100000073497}">Bottle</span></td><td>28</td><td><span title="Codes:{https://spor.ema.europa.eu/rmswi 200000003222}">PolyVinyl Chloride</span></td></tr></table></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://pmda-packinsertno/"/>
          <value value="placeholder2"/>
        </identifier>
        <name value="Tegretol (carbamazepine) 200 mg for tablet in bottles"/>
        <type>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000155527"/>
            <display value="Chemical Medininal Prodcut"/>
          </coding>
        </type>
        <packageFor>
          <reference
                     value="MedicinalProductDefinition/medprodcarbamazepine200"/>
        </packageFor>
        <status>
          <coding>
            <system value="http://hl7.org/fhir/publication-status"/>
            <code value="active"/>
            <display value="Active"/>
          </coding>
        </status>
        <statusDate value="2002-08-01T13:28:17Z"/>
        <containedItemQuantity>
          <value value="200"/>
          <unit value="mg"/>
        </containedItemQuantity>
        <manufacturer>
          <reference value="Organization/orgfujinaga"/>
        </manufacturer>
        <packaging>
          <identifier>
            <system value="https://spor.ema.europa.eu/pmswi"/>
            <value value="123456"/>
          </identifier>
          <type>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="100000073497"/>
              <display value="Bottle"/>
            </coding>
          </type>
          <quantity value="28"/>
          <material>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="200000003222"/>
              <display value="PolyVinyl Chloride"/>
            </coding>
          </material>
        </packaging>
      </PackagedProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/adminprodcarbamazepine200"/>
    <resource>
      <AdministrableProductDefinition>
        <id value="adminprodcarbamazepine200"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="AdministrableProductDefinition_adminprodcarbamazepine200"> </a><p class="res-header-id"><b>Generated Narrative: AdministrableProductDefinition adminprodcarbamazepine200</b></p><a name="adminprodcarbamazepine200"> </a><a name="hcadminprodcarbamazepine200"> </a><a name="adminprodcarbamazepine200-en-US"> </a><p><b>identifier</b>: <code>https://www.who-umc.org/phpid</code>/FB9808F4FED210183F412F9998622287</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href="Bundle-bundlejpicarbamazepine200.html#MedicinalProductDefinition_medprodcarbamazepine200">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><p><b>administrableDoseForm</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 10219000}">Tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 15054000}">15054000</span></p><p><b>producedFrom</b>: <a href="Bundle-bundlejpicarbamazepine200.html#ManufacturedItemDefinition_manitemcarbamazepine200">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</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/rmswi 20053000}">20053000</span></td></tr></table></div>
        </text>
        <identifier>
          <system value="https://www.who-umc.org/phpid"/>
          <value value="FB9808F4FED210183F412F9998622287"/>
        </identifier>
        <status value="active"/>
        <formOf>
          <reference
                     value="MedicinalProductDefinition/medprodcarbamazepine200"/>
        </formOf>
        <administrableDoseForm>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="10219000"/>
          </coding>
          <text value="Tablet"/>
        </administrableDoseForm>
        <unitOfPresentation>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="15054000"/>
          </coding>
        </unitOfPresentation>
        <producedFrom>
          <reference
                     value="ManufacturedItemDefinition/manitemcarbamazepine200"/>
        </producedFrom>
        <routeOfAdministration>
          <code>
            <coding>
              <system value="https://spor.ema.europa.eu/rmswi"/>
              <code value="20053000"/>
            </coding>
          </code>
        </routeOfAdministration>
      </AdministrableProductDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/manitemcarbamazepine200"/>
    <resource>
      <ManufacturedItemDefinition>
        <id value="manitemcarbamazepine200"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ManufacturedItemDefinition_manitemcarbamazepine200"> </a><p class="res-header-id"><b>Generated Narrative: ManufacturedItemDefinition manitemcarbamazepine200</b></p><a name="manitemcarbamazepine200"> </a><a name="hcmanitemcarbamazepine200"> </a><a name="manitemcarbamazepine200-en-US"> </a><p><b>identifier</b>: <code>https://pmda-sccj</code>/placeholder (use: official, )</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title="Codes:{https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/ 10219000}">Tablet</span></p><p><b>unitOfPresentation</b>: <span title="Codes:{https://standardterms.edqm.eu/browse/get_concepts/UOP/ 15054000}">15054000</span></p><p><b>manufacturer</b>: <a href="Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://pmda-sccj"/>
          <value value="placeholder"/>
        </identifier>
        <status value="active"/>
        <manufacturedDoseForm>
          <coding>
            <system
                    value="https://standardterms.edqm.eu/browse/get_concepts_by/SOM/SOM/"/>
            <code value="10219000"/>
          </coding>
          <text value="Tablet"/>
        </manufacturedDoseForm>
        <unitOfPresentation>
          <coding>
            <system
                    value="https://standardterms.edqm.eu/browse/get_concepts/UOP/"/>
            <code value="15054000"/>
          </coding>
        </unitOfPresentation>
        <manufacturer>
          <reference value="Organization/orgfujinaga"/>
        </manufacturer>
      </ManufacturedItemDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/Ingredient/carbamazepine"/>
    <resource>
      <Ingredient>
        <id value="carbamazepine"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_carbamazepine"> </a><p class="res-header-id"><b>Generated Narrative: Ingredient carbamazepine</b></p><a name="carbamazepine"> </a><a name="hccarbamazepine"> </a><a name="carbamazepine-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/33CM23913M (use: official, )</p><p><b>status</b>: Active</p><p><b>for</b>: <a href="Bundle-bundlejpicarbamazepine200.html#ManufacturedItemDefinition_manitemcarbamazepine200">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><p><b>role</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072072}">Active</span></p><h3>Manufacturers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Manufacturer</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></td></tr></table><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://gsrs.ncats.nih.gov/ginas/app/beta 33CM23913M}">carbamazepine</span></td></tr></table><h3>Strengths</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Presentation[x]</b></td><td><b>Basis</b></td></tr><tr><td style="display: none">*</td><td>200 mg</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-RoleClass ACTIB}">active ingredient - basis of strength</span></td></tr></table></blockquote></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="33CM23913M"/>
        </identifier>
        <status value="active"/>
        <for>
          <reference
                     value="ManufacturedItemDefinition/manitemcarbamazepine200"/>
        </for>
        <role>
          <coding>
            <system value="https://spor.ema.europa.eu/rmswi"/>
            <code value="100000072072"/>
            <display value="Active"/>
          </coding>
        </role>
        <manufacturer>
          <manufacturer>
            <reference value="Organization/orgfujinaga"/>
          </manufacturer>
        </manufacturer>
        <substance>
          <code>
            <concept>
              <coding>
                <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/>
                <code value="33CM23913M"/>
                <display value="carbamazepine"/>
              </coding>
            </concept>
          </code>
          <strength>
            <presentationQuantity>
              <value value="200"/>
              <unit value="mg"/>
            </presentationQuantity>
            <basis>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/>
                <code value="ACTIB"/>
              </coding>
              <text value="active ingredient - basis of strength"/>
            </basis>
          </strength>
        </substance>
      </Ingredient>
    </resource>
  </entry>
  <entry>
    <fullUrl
             value="http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/subcarbamazepine200"/>
    <resource>
      <SubstanceDefinition>
        <id value="subcarbamazepine200"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_subcarbamazepine200"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition subcarbamazepine200</b></p><a name="subcarbamazepine200"> </a><a name="hcsubcarbamazepine200"> </a><a name="subcarbamazepine200-en-US"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/33CM23913M (use: official, )</p><p><b>version</b>: 39</p><p><b>status</b>: <span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}">Validated (UNII)</span></p><p><b>description</b>: </p><div><p>White to pale yellow</p>
</div><p><b>manufacturer</b>: <a href="Bundle-bundlejpicarbamazepine200.html#Organization_orgfujinaga">Bundle: identifier = https://www.pmda.jp/#jpiplaceholder; type = document; timestamp = 2002-08-01 13:28:17+0000</a></p><h3>Structures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>MolecularFormula</b></td></tr><tr><td style="display: none">*</td><td>C15H12N2O</td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>carbamazepine</td><td><span title="Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta/ 1}">Chemical Name</span></td></tr></table></div>
        </text>
        <identifier>
          <use value="official"/>
          <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
          <value value="33CM23913M"/>
        </identifier>
        <version value="39"/>
        <status>
          <coding>
            <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
            <code value="1"/>
          </coding>
          <text value="Validated (UNII)"/>
        </status>
        <description value="White to pale yellow"/>
        <manufacturer>
          <reference value="Organization/orgfujinaga"/>
        </manufacturer>
        <structure>
          <molecularFormula value="C15H12N2O"/>
        </structure>
        <name>
          <name value="carbamazepine"/>
          <type>
            <coding>
              <system value="https://gsrs.ncats.nih.gov/ginas/app/beta/"/>
              <code value="1"/>
            </coding>
            <text value="Chemical Name"/>
          </type>
        </name>
      </SubstanceDefinition>
    </resource>
  </entry>
</Bundle>