electronic Product Information (ePI) document
 <!-- Root/Level 1 Section. id value is optional, and in EMA systems id has a GUID format. --> <section id="66b16954-0d4e-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="ANNEX II" /> <!-- 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="200000029850" /> <display value="ANNEX II" /> </coding> </code> <!-- Level 2 Section(s). id value is optional, and in EMA systems id has a GUID format. --> <section id="6db16954-0d4e-ee11-be6e-000d3aaa06fe"> <title value="A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE" /> <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="200000029851" /> <display value="A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE" /> </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><span>Name and address of the manufacturers responsible for batch release</span></p><p><span>CompanyY Czech Industries s.r.o.</span></p><p><span>Ostravská 29, c.p. 305</span></p><p><span>CZ-74770 Opava - Komárov </span></p><p><span>Czech Republic</span></p><p><span> </span></p><p><span>Merckle GmbH</span></p><p><span>Graf-Arco-Str. 3, 89079 Ulm</span></p><p><span>Germany</span></p><p><span> </span></p><p><span>CompanyY Operations Poland Sp. z.o.o</span></p><p><span>ul. Mogilska 80. 31-546, Krakow</span></p><p><span>Poland</span></p><p><span> </span></p><p><span>TEVA Pharmaceutical Works Private Limited Company</span></p><p><span>Pallagi út 13, 4042 Debrecen</span></p><p><span>Hungary</span></p><p><span> </span></p><p><span>TEVA PHARMA S.L.U.</span></p><p><span>C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza</span></p><p><span>Spain</span></p><p><span> </span></p><p><span>CompanyY Pharma B.V.</span></p><p><span>Swensweg 5, 2031 GA Haarlem</span></p><p><span>The Netherlands</span></p><p><span> </span></p><p><span>PLIVA Croatia Ltd.</span></p><p><span>Prilaz baruna Filipovica 25</span></p><p><span>10000 Zagreb</span></p><p><span>Croatia</span></p><p><span> </span></p><p><span>The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.</span></p></div> </text> </section> <section id="71b16954-0d4e-ee11-be6e-000d3aaa06fe"> <title value="B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029852" /> <display value="B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p><span>Medicinal product subject to restricted medical prescription</span><span> (see Annex I: Summary of Product Characteristics, section 4.2).</span></p></div> </text> </section> <section id="79b16954-0d4e-ee11-be6e-000d3aaa06fe"> <title value="C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029854" /> <display value="C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION" /> </coding> </code> <section id="7db16954-0d4e-ee11-be6e-000d3aaa06fe"> <title value="Periodic safety update reports (PSURs)" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029855" /> <display value="Periodic safety update reports (PSURs)" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p><span>The </span>requirements for submission of<span> PSURs for this </span>medicinal<span> product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and </span>any subsequent updates <span>published on the European medicines web-portal.</span></p></div> </text> </section> </section> <section id="83b16954-0d4e-ee11-be6e-000d3aaa06fe"> <title value="D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029856" /> <display value="D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT" /> </coding> </code> <section id="87b16954-0d4e-ee11-be6e-000d3aaa06fe"> <title value="Risk management plan (RMP)" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029857" /> <display value="Risk management plan (RMP)" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><p><span>Not applicable.</span></p></div> </text> </section> </section> </section> </Composition> </resource> </entry> </Bundle>