{
  "resourceType" : "Bundle",
  "id" : "bundle-finasteride-raw",
  "meta" : {
    "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"]
  },
  "language" : "en",
  "identifier" : {
    "system" : "https://www.gravitatehealth.eu/sid/doc",
    "value" : "himss-finasteride"
  },
  "type" : "document",
  "timestamp" : "2023-06-27T10:09:22Z",
  "entry" : [{
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-finasteride",
    "resource" : {
      "resourceType" : "Composition",
      "id" : "composition-en-finasteride",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"]
      },
      "language" : "en",
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-finasteride\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-finasteride</b></p><a name=\"composition-en-finasteride\"> </a><a name=\"hccomposition-en-finasteride\"> </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: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.gravitatehealth.eu/sid/doc</code>/himss-finasteride</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: EMA</p><p><b>title</b>: TEST PURPOSES ONLY - finasteride</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>2022-02-16 13:28:17+0000</td></tr></table></div>"
      },
      "identifier" : [{
        "system" : "https://www.gravitatehealth.eu/sid/doc",
        "value" : "himss-finasteride"
      }],
      "status" : "final",
      "type" : {
        "coding" : [{
          "system" : "https://spor.ema.europa.eu/rmswi/",
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        "text" : "Package Leaflet"
      },
      "category" : [{
        "coding" : [{
          "system" : "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs",
          "code" : "R",
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        }]
      }],
      "subject" : [{
        "reference" : "MedicinalProductDefinition/himss-finasteride-mpd"
      }],
      "date" : "2022-02-16T13:28:17Z",
      "author" : [{
        "display" : "EMA"
      }],
      "title" : "TEST PURPOSES ONLY - finasteride",
      "attester" : [{
        "mode" : {
          "coding" : [{
            "system" : "http://hl7.org/fhir/composition-attestation-mode",
            "code" : "official"
          }]
        },
        "time" : "2022-02-16T13:28:17Z"
      }],
      "section" : [{
        "title" : "B. Package Leaflet",
        "code" : {
          "coding" : [{
            "system" : "https://spor.ema.europa.eu/rmswi/",
            "code" : "100000155538"
          }],
          "text" : "B. Package Leaflet"
        },
        "text" : {
          "status" : "additional",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>"
        },
        "section" : [{
          "title" : "Package leaflet: Information for the user",
          "code" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }],
            "text" : "Package leaflet: Information for the user"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><h2>Finasteride 5 mg film-coated tablets</h2><h2>(Finasteride)</h2><p>Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.</p><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor, pharmacist or nurse.</li><li>This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.</li><li>If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul><!--  [oai_citation:0‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>"
          }
        },
        {
          "title" : "What is in this leaflet",
          "code" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }],
            "text" : "What is in this leaflet"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ol><li>What Finasteride is and what it is used for</li><li>What you need to know before you take Finasteride</li><li>How to take Finasteride</li><li>Possible side effects</li><li>How to store Finasteride</li><li>Contents of the pack and other information</li></ol><!--  [oai_citation:1‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>"
          }
        },
        {
          "title" : "1. What finasteride is and what it is used for",
          "code" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }],
            "text" : "1. What finasteride is and what it is used for"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Finasteride contains the active substance finasteride which belongs to the group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men.</p><p>Finasteride is used in the treatment and control of benign (non-cancerous) enlargement of the prostate (benign prostatic hyperplasia BPH). It reduces the risk of you developing a sudden inability to pass urine (acute urinary retention) and the need for surgery.</p><!--  [oai_citation:2‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>"
          }
        },
        {
          "title" : "2. What you need to know before you take finasteride",
          "code" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }],
            "text" : "2. What you need to know before you take finasteride"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><h3>Do not take Finasteride if you:</h3><ul><li>are allergic to finasteride or any of the other ingredients (listed in section 6)</li><li>are a woman (see also under ‘Pregnancy, breast-feeding and fertility’)</li><li>are a child</li></ul><!--  [oai_citation:3‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Warnings and precautions</h3><ul><li>reduced liver function</li><li>difficulty emptying your bladder completely or greatly reduced urine flow (exclude other urinary obstruction first)</li><li>any changes in breast tissue (lumps, pain, enlargement, nipple discharge)—report these promptly</li></ul><!--  [oai_citation:4‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><p>If your sexual partner is or may be pregnant, avoid exposing her to your semen which could contain a tiny amount of the drug.</p><!--  [oai_citation:5‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Mood alterations and depression</h3><p>Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported. If you experience these, contact your doctor as soon as possible.</p><!--  [oai_citation:6‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Other medicines and Finasteride</h3><p>Finasteride does not usually interfere with other medicines. Tell your doctor or pharmacist if you are taking any other medicines.</p><!--  [oai_citation:7‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Finasteride with food and drink</h3><p>Finasteride can be taken with or without food.</p><!--  [oai_citation:8‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Pregnancy, breast-feeding and fertility</h3><ul><li>Finasteride is only intended for men.</li><li>Women who are or may be pregnant should not handle broken or crushed tablets—absorption may cause fetal genital malformation.</li></ul><!--  [oai_citation:9‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Driving and using machines</h3><p>No evidence suggests Finasteride affects driving or machine use.</p><!--  [oai_citation:10‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Finasteride contains lactose</h3><p>If you have an intolerance to some sugars, contact your doctor before taking this medicine.</p><!--  [oai_citation:11‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Finasteride contains sodium</h3><p>This medicine contains less than 1 mmol sodium (23 mg) per tablet (essentially ‘sodium-free’).</p><!--  [oai_citation:12‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>"
          }
        },
        {
          "title" : "3. How to take finasteride",
          "code" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }],
            "text" : "3. How to take finasteride"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The recommended dose is one tablet daily (5 mg finasteride). Swallow the film-coated tablet whole; do not break or crush. It may be taken with or without food.</p><!--  [oai_citation:13‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>If you take more Finasteride than you should</h3><p>Contact a doctor, hospital casualty department or poison centre immediately.</p><!--  [oai_citation:14‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>If you forget to take Finasteride</h3><p>Do not take a double dose. Take the next dose when it is due.</p><!--  [oai_citation:15‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>If you stop taking Finasteride</h3><p>Although improvement may be noticed shortly, treatment should continue for at least 6 months. Do not alter or stop without medical advice.</p><!--  [oai_citation:16‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>"
          }
        },
        {
          "title" : "4. Possible side effects",
          "code" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }],
            "text" : "4. Possible side effects"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><h3>Stop using and contact your doctor immediately if you experience any of the following (angioedema):</h3><ul><li>Swelling of face, tongue or throat; difficulty swallowing; hives; breathing difficulties</li></ul><!--  [oai_citation:17‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Common (may affect up to 1 in 10 people):</h3><ul><li>Decreased ejaculate volume</li><li>Impotence</li><li>Reduced sex drive</li></ul><h3>Uncommon (may affect up to 1 in 100 people):</h3><ul><li>Rash</li><li>Ejaculation problems that may continue after stopping</li><li>Breast swelling or tenderness</li></ul><h3>Not known (frequency cannot be estimated):</h3><ul><li>Itching, hives</li><li>Palpitations</li><li>Increased liver enzymes</li><li>Testicular pain</li><li>Male infertility or poor semen quality</li><li>Depression, anxiety</li></ul><!--  [oai_citation:18‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Combination therapy with doxazosin</h3><p>When used with doxazosin, higher incidence of asthenia (16.8%), postural hypotension (17.8%), dizziness (23.2%) and ejaculation disorders (14.1%) versus placebo.</p><!--  [oai_citation:19‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Reporting of side effects</h3><p>Talk to your doctor or pharmacist about any side effects. You can also report them via the Yellow Card Scheme at <a href=\"https://www.mhra.gov.uk/yellowcard\" target=\"_blank\" rel=\"noopener noreferrer\">www.mhra.gov.uk/yellowcard</a>.</p><!--  [oai_citation:20‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>"
          }
        },
        {
          "title" : "5. How to store finasteride",
          "code" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }],
            "text" : "5. How to store finasteride"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Keep out of sight and reach of children.</li><li>No special storage conditions required.</li><li>Do not use after the expiry date on the label (last day of that month).</li><li>Do not dispose via wastewater or household waste; ask your pharmacist.</li></ul><!--  [oai_citation:21‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>"
          }
        },
        {
          "title" : "6. Contents of the pack and other information",
          "code" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000155538"
            }],
            "text" : "6. Contents of the pack and other information"
          },
          "text" : {
            "status" : "additional",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><h3>What Finasteride contains</h3><ul><li><strong>Active substance:</strong> finasteride 5 mg per film-coated tablet.</li><li><strong>Other ingredients:</strong><ul><li>Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, sodium starch glycolate, docusate sodium, magnesium stearate.</li><li>Film coating: hypromellose (E 464), titanium dioxide (E 171), indigo carmine aluminium lake (E 132), talc, iron oxide yellow (E 172).</li></ul></li></ul><!--  [oai_citation:22‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>What Finasteride looks like and pack sizes</h3><p>Blue, round, film-coated tablets debossed ‘H’ and ‘37’. Available in blister packs of 15, 28, 30, 50, 90, 98 or 100 tablets.</p><!--  [oai_citation:23‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Marketing Authorisation Holder and Manufacturer</h3><p><strong>Marketing Authorisation Holder:</strong></p><p>Amarox Limited, Congress House, 14 Lyon Road, Harrow, Middlesex HA1 2EN, United Kingdom</p><p><strong>Manufacturer:</strong></p><p>Pharmadox Healthcare Ltd, Kordin Industrial Park, Paola PLA 3000, Malta</p><p>or</p><p>Amarox Limited, Congress House, 14 Lyon Road, Harrow, Middlesex HA1 2EN, United Kingdom</p><!--  [oai_citation:24‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><h3>Authorisations in the EEA</h3><ul><li>Germany: Finasterid Amarox 5 mg Filmtabletten</li><li>Denmark: Finasterid Amarox 5 mg Filmovertrukne tabletter</li><li>France: Finasteride Amarox 5 mg comprimé pelliculé</li><li>Spain: Finasterida Tarbis 5 mg comprimidos recubiertos con película EFG</li><li>Italy: Finasterida Amarox</li><li>Netherlands: Finasteride Amarox 5 mg filmomhulde tabletten</li><li>Portugal: Finasterida Amarox</li><li>Sweden: Finasteride Amarox 5 mg Filmdragerad tablett</li><li>United Kingdom: Finasteride 5 mg film-coated tablets</li></ul><!--  [oai_citation:25‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --><p>This leaflet was last revised in 09/2021.</p><!--  [oai_citation:26‡pil.13543.pdf](file-service://file-JCS7gTrRt25FFSUPp8bKGr) --></div>"
          }
        }]
      }]
    }
  },
  {
    "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/Composition/himss-finasteride-mpd",
    "resource" : {
      "resourceType" : "MedicinalProductDefinition",
      "id" : "himss-finasteride-mpd",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_himss-finasteride-mpd\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition himss-finasteride-mpd</b></p><a name=\"himss-finasteride-mpd\"> </a><a name=\"hchimss-finasteride-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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/uv/emedicinal-product-info/STU1/StructureDefinition-MedicinalProductDefinition-uv-epi.html\">MedicinalProductDefinition (ePI)</a></p></div><p><b>identifier</b>: <code>https://www.gravitatehealth.eu/sid/doc</code>/himss-finasteride</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: finasteride Flexpen 100 units/ml solution for injection in pre-filled pens</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: finasteride FlexPen</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Insulin</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 100 units/ml</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: solution for injection in pre-filled pens</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/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>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 GBR}\">United Kingdom</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 GBR}\">United Kingdom</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">English</span></td></tr></table></blockquote></div>"
      },
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          "code" : "MedicinalProduct",
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      },
      "domain" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/medicinal-product-domain",
          "code" : "Human",
          "display" : "Human use"
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      },
      "status" : {
        "coding" : [{
          "system" : "http://hl7.org/fhir/publication-status",
          "code" : "active",
          "display" : "active"
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      },
      "legalStatusOfSupply" : {
        "coding" : [{
          "system" : "https://spor.ema.europa.eu/rmswi",
          "code" : "100000072084",
          "display" : "Medicinal product subject to medical prescription"
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      },
      "name" : [{
        "productName" : "finasteride Flexpen 100 units/ml solution for injection in pre-filled pens",
        "type" : {
          "coding" : [{
            "system" : "https://spor.ema.europa.eu/lists/220000000000",
            "code" : "220000000001",
            "display" : "Full name"
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        },
        "part" : [{
          "part" : "finasteride FlexPen",
          "type" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/lists/220000000000",
              "code" : "220000000002",
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        {
          "part" : "Insulin",
          "type" : {
            "coding" : [{
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              "code" : "220000000003",
              "display" : "Scientific name part"
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        },
        {
          "part" : "100 units/ml",
          "type" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/lists/220000000000",
              "code" : "220000000004",
              "display" : "Strength part"
            }]
          }
        },
        {
          "part" : "solution for injection in pre-filled pens",
          "type" : {
            "coding" : [{
              "system" : "https://spor.ema.europa.eu/lists/220000000000",
              "code" : "220000000005",
              "display" : "Pharmaceutical dose form part"
            }]
          }
        }],
        "usage" : [{
          "country" : {
            "coding" : [{
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              "code" : "GBR",
              "display" : "United Kingdom"
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          "jurisdiction" : {
            "coding" : [{
              "system" : "urn:iso:std:iso:3166",
              "code" : "GBR",
              "display" : "United Kingdom"
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          "language" : {
            "coding" : [{
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              "code" : "en",
              "display" : "English"
            }]
          }
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      }]
    }
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}