electronic Product Information (ePI) document
 <!-- Root/Level 1 Section. id value is optional, and in EMA systems id has a GUID format. --> <section id="0501625a-0d4e-ee11-be6e-000d3aaa06fe"> <!-- The title for this particular section. Section headings are standardized for different types of documents and they give guidance on how the document is organized. --> <title value="LABELLING" /> <!-- Every section has a unique code associated, that identifies the nature of content contained within the section. --> <!-- Section codes are defined in EMA Referentials Management System (RMS) and published in QRD template documents. --> <code> <coding> <!-- All document section codes are defined in the RMS list http://ema.europa.eu/fhir/CodeSystem/200000029659 --> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029861" /> <display value="LABELLING" /> </coding> </code> <!-- Level 2 Section(s). id value is optional, and in EMA systems id has a GUID format. --> <section id="0f01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029862" /> <display value="PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}" /> </coding> </code> <!-- Level 3 Section(s). id value is optional, and in EMA systems id has a GUID format. --> <section id="1a01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="1. NAME OF THE MEDICINAL PRODUCT" /> <code> <coding> <!-- All document section codes are defined in the RMS list http://ema.europa.eu/fhir/CodeSystem/200000029659 --> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029863" /> <display value="1. NAME OF THE MEDICINAL PRODUCT" /> </coding> </code> <!-- Section's content - in XHTML - goes into the text.div element. Content should contain the formatting elements allowed in the FHIR Narrative element https://www.hl7.org/fhir/narrative.html#xhtml Suggested list of HTML elements (and styling properties) is currently under analysis and suggested list below is expected to be revised. Suggested HTML elements include: p paragraph <p></p> span inline container <span></span> img image <img /> sup superscript text <sup></sup> sub subscript text <sub></sub> strong bold text <strong></strong> i italic style <i></i> em emphasized text <em></em> s strikethrough <s></s> q quotation mark <q></q> ol ordered list <ol></ol> ul unordered list <ul></ul> a anchor <a></a> table table <table></table> Headings h1 - h6 are not recommended elements in the section content narrative, as headings are related with section title and section nested level. Suggested styling properties include: table: width auto, 0-numeric value <table option-width="150"></table> border dark, light, black (deprecated) <table option-border="light"></table> align auto, left, center, right <table option-align="auto"></table> scroll yes, no <table option-scroll="yes"></table> preset blend, strips-rows, strips-columns <table option-preset="strips-rows"></table> color default, red, blue, green <table option-color="red"></table> tr: (table row) align auto, left, center, right <tr option-align="center"></tr> color default, red, blue, green <tr option-color="red"></tr> td: (table data or cell) align auto, left, center, right <td option-align="center"></td> color default, red, blue, green <td option-color="red"></td> img: width auto, 0-numeric value <img option-width="40" /> align auto, left, center, right <img option-align="auto" /> filter no, grayscale <img option-filter="no" /> p: align auto, left, center, right <p option-align="auto"></p> color default, red, blue, green <p option-color="red"></p> ol: align auto, left, center, right <ol option-align="auto"></ol> color default, red, blue, green <li option-color="red"></li> ul: align auto, left, center, right <ul option-align="auto"></ul> color default, red, blue, green <li option-color="red"></li> li: color default, red, blue, green <li option-color="red"></li> --> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Imatinib CompanyY 100 mg hard capsules</p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">ProductX</p></div> </text> </section> <section id="2601625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="2. STATEMENT OF ACTIVE SUBSTANCE(S)" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029864" /> <display value="2. STATEMENT OF ACTIVE SUBSTANCE(S)" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Each hard capsule contains 100 mg of imatinib (as mesilate).</p></div> </text> </section> <section id="2e01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="3. LIST OF EXCIPIENTS" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029865" /> <display value="3. LIST OF EXCIPIENTS" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml">[Include content on list of excipients]</div> </text> </section> <section id="3801625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="4. PHARMACEUTICAL FORM AND CONTENTS" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029866" /> <display value="4. PHARMACEUTICAL FORM AND CONTENTS" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">Capsule, hard</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"> </p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">20x1 hard capsules</p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">60 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">60x1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">120 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">120x1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">180x1 hard capsules</span></p></div> </text> </section> <section id="4101625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="5. METHOD AND ROUTE(S) OF ADMINISTRATION" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029867" /> <display value="5. METHOD AND ROUTE(S) OF ADMINISTRATION" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Read the package leaflet before use.</p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Oral use.</p></div> </text> </section> <section id="4801625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029868" /> <display value="6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Keep out of the sight and reach of children.</p></div> </text> </section> <section id="5101625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="7. OTHER SPECIAL WARNING(S), IF NECESSARY" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029869" /> <display value="7. OTHER SPECIAL WARNING(S), IF NECESSARY" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml">[Include special warnings]</div> </text> </section> <section id="5c01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="8. EXPIRY DATE" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029870" /> <display value="8. EXPIRY DATE" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">EXP</p></div> </text> </section> <section id="6401625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="9. SPECIAL STORAGE CONDITIONS" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029871" /> <display value="9. SPECIAL STORAGE CONDITIONS" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml">[Special storage conditions]</div> </text> </section> <section id="6d01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029872" /> <display value="10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml">[Special precautions]</div> </text> </section> <section id="7601625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029873" /> <display value="11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">CompanyY B.V.</p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Swensweg 5</p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">2031 GA Haarlem</p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">The Netherlands</p></div> </text> </section> <section id="8301625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="12. MARKETING AUTHORISATION NUMBER(S)" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029874" /> <display value="12. MARKETING AUTHORISATION NUMBER(S)" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">EU/1/12/808/021    <span style="background: lightgrey;">20 x 1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/022    60 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/023    60 x 1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/024    120 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/025    120 x 1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/026    180 x 1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/027    20 x 1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/028    60 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/029    60 x 1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/030    120 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/031    120 x 1 hard capsules</span></p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">EU/1/12/808/03</span><span style="background: lightgrey;">2    180 x 1 hard capsules</span></p></div> </text> </section> <section id="8d01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="13. BATCH NUMBER" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029875" /> <display value="13. BATCH NUMBER[, DONATION AND PRODUCT CODES]" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Lot</p></div> </text> </section> <section id="9701625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="14. GENERAL CLASSIFICATION FOR SUPPLY" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029876" /> <display value="14. GENERAL CLASSIFICATION FOR SUPPLY" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml">[General classification for supply]</div> </text> </section> <section id="9f01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="15. INSTRUCTIONS ON USE" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029877" /> <display value="15. INSTRUCTIONS ON USE" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml">[Instructions on use]</div> </text> </section> <section id="a501625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="16. INFORMATION IN BRAILLE" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029878" /> <display value="16. INFORMATION IN BRAILLE" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Imatinib CompanyY 100 mg hard capsules</p></div> </text> </section> <section id="ae01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="17. UNIQUE IDENTIFIER - 2D BARCODE" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029879" /> <display value="17. UNIQUE IDENTIFIER - 2D BARCODE" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="margin: 0cm 0cm 0.0001pt; line-height: 13pt; font-size: 11pt; font-family: 'Times New Roman', serif;"><span style="background: lightgrey;">2D barcode carrying the unique identifier included.</span></p></div> </text> </section> <section id="b801625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="18. UNIQUE IDENTIFIER - HUMAN READABLE DATA" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029880" /> <display value="18. UNIQUE IDENTIFIER - HUMAN READABLE DATA" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="margin: 0cm 0cm 0.0001pt; line-height: 13pt; font-size: 11pt; font-family: 'Times New Roman', serif;">PC</p><p style="margin: 0cm 0cm 0.0001pt; line-height: 13pt; font-size: 11pt; font-family: 'Times New Roman', serif;">SN</p><p style="margin: 0cm 0cm 0.0001pt; line-height: 13pt; font-size: 11pt; font-family: 'Times New Roman', serif;">NN</p></div> </text> </section> </section> <section id="bf01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029881" /> <display value="MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}" /> </coding> </code> <section id="ca01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="1. NAME OF THE MEDICINAL PRODUCT" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029882" /> <display value="1. NAME OF THE MEDICINAL PRODUCT" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Imatinib CompanyY 100 mg hard capsules</p><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">imatinib</p></div> </text> </section> <section id="d301625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="2. NAME OF THE MARKETING AUTHORISATION HOLDER" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029883" /> <display value="2. NAME OF THE MARKETING AUTHORISATION HOLDER" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">CompanyY B.V.</p></div> </text> </section> <section id="dc01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="3. EXPIRY DATE" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029884" /> <display value="3. EXPIRY DATE" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">EXP</p></div> </text> </section> <section id="e501625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="4. BATCH NUMBER" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029885" /> <display value="4. BATCH NUMBER[, DONATION AND PRODUCT CODES]" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p style="line-height: normal; margin: 0cm 0cm 0.0001pt; font-size: 11pt; font-family: 'Times New Roman', serif;">Lot</p></div> </text> </section> <section id="ee01625a-0d4e-ee11-be6e-000d3aaa06fe"> <title value="5. OTHER" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029886" /> <display value="5. OTHER" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml">[Other content]</div> </text> </section> </section> </section> </Composition> </resource> </entry> </Bundle>