FQL is a query language that allows you to retrieve, filter and project data from any data source containing FHIR Resources. It brings the power of three existing languages together: SQL, JSON and FhirPath. It allows you to create tables and is useful for gaining insight and perform quality control.
<Bundle xmlns="http://hl7.org/fhir"> <meta> <versionId value="1" /> <lastUpdated value="2025-03-31T16:45:17.089+00:00" /> </meta> <identifier> <system value="http://ema.europa.eu/fhir/epiId" /> <value value="7097ba24-4f0e-f011-a4dd-6045bd977e93" /> </identifier> <type value="collection" /> <timestamp value="2025-03-31T16:45:17.089+00:00" /> <entry> <fullUrl value="urn:uuid:7097ba24-4f0e-f011-a4dd-6045bd977e93" /> <resource> <List> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml">electronic Product Information (ePI) master document list</div> </text> <extension url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-authorization-type"> <valueString value="CAP" /> </extension> <extension url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-marketing-authorisation-holder"> <valueIdentifier> <system value="https://spor.ema.europa.eu/v1/organisations/" /> <value value="ORG-100005184" /> <!-- display value="[ INACTIVE ] 123Ratio Sp. z o.o." / --> </valueIdentifier> </extension> <extension url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-medicine-domain"> <valueCoding> <system value="http://ema.europa.eu/fhir/CodeSystem/100000000004" /> <code value="100000000012" /> <display value="Human Use" /> </valueCoding> </extension> <extension url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-procedure-number"> <valueIdentifier> <system value="http://ema.europa.eu/fhir/procedureNumber/" /> <value value="5456" /> </valueIdentifier> </extension> <extension url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-procedure-number"> <valueIdentifier> <system value="http://ema.europa.eu/fhir/procedureNumber/" /> <value value="98989" /> </valueIdentifier> </extension> <extension url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-regulatory-agency"> <valueIdentifier> <system value="https://spor.ema.europa.eu/v1/organisations/" /> <value value="ORG-100013412" /> <!-- display value="European Medicines Agency" / --> </valueIdentifier> </extension> <extension url="http://ema.europa.eu/fhir/StructureDefinition/ext-epi-version-number"> <valueString value="2" /> </extension> <identifier> <system value="http://ema.europa.eu/fhir/epiId" /> <value value="EPI/25/507" /> </identifier> <status value="current" /> <mode value="working" /> <title value="Publish test with multiple proc numbers" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/100000155531" /> <code value="100000155539" /> <display value="Combined File of all Documents" /> </coding> </code> <entry> <item> <reference value="urn:uuid:83c9a229-4f0e-f011-998b-7c1e5272e500" /> <display value="Summary of Product Characteristics" /> </item> </entry> <entry> <item> <reference value="urn:uuid:c8f9a62f-4f0e-f011-998b-7c1e5272e500" /> <display value="Annex II" /> </item> </entry> <entry> <item> <reference value="urn:uuid:a001a435-4f0e-f011-998b-7c1e5272e500" /> <display value="Labelling" /> </item> </entry> <entry> <item> <reference value="urn:uuid:e5f9a62f-4f0e-f011-998b-7c1e5272e500" /> <display value="Package Leaflet" /> </item> </entry> </List> </resource> </entry> <entry> <fullUrl value="urn:uuid:83c9a229-4f0e-f011-998b-7c1e5272e500" /> <resource> <Bundle> <id value="83c9a229-4f0e-f011-998b-7c1e5272e500" /> <meta> <versionId value="1" /> <lastUpdated value="2025-03-31T16:45:17.089+00:00" /> </meta> <identifier> <system value="http://ema.europa.eu/fhir/epiDocument" /> <value value="83c9a229-4f0e-f011-998b-7c1e5272e500" /> </identifier> <type value="document" /> <timestamp value="2025-03-31T16:45:17.089+00:00" /> <entry> <fullUrl value="urn:uuid:83c9a229-4f0e-f011-998b-7c1e5272e500" /> <resource> <Composition> <language value="en" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml" lang="en" xml:lang="en">Summary of Product Characteristics</div> </text> <status value="final" /> <type> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/100000155531" /> <code value="100000155532" /> <display value="Summary of Product Characteristics" /> </coding> </type> <date value="2025-03-31" /> <author> <identifier> <value value="[ INACTIVE ] 123Ratio Sp. z o.o." /> </identifier> </author> <title value="Summary of Product Characteristics" /> <section id="85c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="SUMMARY OF PRODUCT CHARACTERISTICS" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029791" /> <display value="SUMMARY OF PRODUCT CHARACTERISTICS" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="88c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="1. NAME OF THE MEDICINAL PRODUCT" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029792" /> <display value="1. NAME OF THE MEDICINAL PRODUCT" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="89c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029793" /> <display value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="92c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="3. PHARMACEUTICAL FORM" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029797" /> <display value="3. PHARMACEUTICAL FORM" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="93c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4. CLINICAL PARTICULARS" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029798" /> <display value="4. CLINICAL PARTICULARS" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="96c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.1 Therapeutic indications" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029799" /> <display value="4.1 Therapeutic indications" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="97c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.2 Posology and method of administration" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029800" /> <display value="4.2 Posology and method of administration" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="9ec9a229-4f0e-f011-998b-7c1e5272e500"> <title value="Posology" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029801" /> <display value="Posology" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="aac9a229-4f0e-f011-998b-7c1e5272e500"> <title value="Method of administration" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029803" /> <display value="Method of administration" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> <section id="b7c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.3 Contraindications" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029805" /> <display value="4.3 Contraindications" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b9c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.4 Special warnings and precautions for use" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029806" /> <display value="4.4 Special warnings and precautions for use" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="bdc9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.5 Interaction with other medicinal products and other forms of interaction" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029809" /> <display value="4.5 Interaction with other medicinal products and other forms of interaction" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="c1c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.6 Fertility, pregnancy and lactation" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029811" /> <display value="4.6 Fertility, pregnancy and lactation" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="ccc9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.7 Effects on ability to drive and use machines" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029815" /> <display value="4.7 Effects on ability to drive and use machines" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="cdc9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.8 Undesirable effects" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029816" /> <display value="4.8 Undesirable effects" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="d2c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="Reporting of suspected adverse reactions" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029818" /> <display value="Reporting of suspected adverse reactions" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> <section id="d4c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="4.9 Overdose" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029819" /> <display value="4.9 Overdose" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> <section id="d7c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="5. PHARMACOLOGICAL PROPERTIES" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029821" /> <display value="5. PHARMACOLOGICAL PROPERTIES" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="d9c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="5.1 Pharmacodynamic properties" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029822" /> <display value="5.1 Pharmacodynamic properties" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="e4c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="5.2 Pharmacokinetic properties" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029827" /> <display value="5.2 Pharmacokinetic properties" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="f7c9a229-4f0e-f011-998b-7c1e5272e500"> <title value="5.3 Preclinical safety data" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029834" /> <display value="5.3 Preclinical safety data" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> <section id="aff9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="6. PHARMACEUTICAL PARTICULARS" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029836" /> <display value="6. PHARMACEUTICAL PARTICULARS" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="b1f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="6.1 List of excipients" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029837" /> <display value="6.1 List of excipients" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b2f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="6.2 Incompatibilities" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029838" /> <display value="6.2 Incompatibilities" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b4f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="6.3 Shelf life" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029839" /> <display value="6.3 Shelf life" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b6f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="6.4 Special precautions for storage" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029840" /> <display value="6.4 Special precautions for storage" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b7f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="6.5 Nature and contents of container <and special equipment for use, administration or implantation>" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029841" /> <display value="6.5 Nature and contents of container [and special equipment for use, administration or implantation]" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b9f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="6.6 Special precautions for disposal <and other handling>" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029842" /> <display value="6.6 Special precautions for disposal [and other handling]" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> <section id="bdf9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="7. MARKETING AUTHORISATION HOLDER" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029844" /> <display value="7. MARKETING AUTHORISATION HOLDER" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="bff9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="8. MARKETING AUTHORISATION NUMBER(S)" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029845" /> <display value="8. MARKETING AUTHORISATION NUMBER(S)" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="c1f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029846" /> <display value="9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="c2f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="10. DATE OF REVISION OF THE TEXT" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029847" /> <display value="10. DATE OF REVISION OF THE TEXT" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> </Composition> </resource> </entry> </Bundle> </resource> </entry> <entry> <fullUrl value="urn:uuid:c8f9a62f-4f0e-f011-998b-7c1e5272e500" /> <resource> <Bundle> <id value="c8f9a62f-4f0e-f011-998b-7c1e5272e500" /> <meta> <versionId value="1" /> <lastUpdated value="2025-03-31T16:45:17.089+00:00" /> </meta> <identifier> <system value="http://ema.europa.eu/fhir/epiDocument" /> <value value="c8f9a62f-4f0e-f011-998b-7c1e5272e500" /> </identifier> <type value="document" /> <timestamp value="2025-03-31T16:45:17.089+00:00" /> <entry> <fullUrl value="urn:uuid:c8f9a62f-4f0e-f011-998b-7c1e5272e500" /> <resource> <Composition> <language value="en" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml" lang="en" xml:lang="en">Annex II</div> </text> <status value="final" /> <type> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/100000155531" /> <code value="100000155533" /> <display value="Annex II" /> </coding> </type> <date value="2025-03-31" /> <author> <identifier> <value value="[ INACTIVE ] 123Ratio Sp. z o.o." /> </identifier> </author> <title value="Annex II" /> <section id="caf9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="ANNEX II" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029850" /> <display value="ANNEX II" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="ccf9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE" /> <code> <coding> <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> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="cef9a62f-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="d2f9a62f-4f0e-f011-998b-7c1e5272e500"> <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> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="d5f9a62f-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> <section id="d7f9a62f-4f0e-f011-998b-7c1e5272e500"> <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> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="daf9a62f-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> </section> </Composition> </resource> </entry> </Bundle> </resource> </entry> <entry> <fullUrl value="urn:uuid:a001a435-4f0e-f011-998b-7c1e5272e500" /> <resource> <Bundle> <id value="a001a435-4f0e-f011-998b-7c1e5272e500" /> <meta> <versionId value="1" /> <lastUpdated value="2025-03-31T16:45:17.089+00:00" /> </meta> <identifier> <system value="http://ema.europa.eu/fhir/epiDocument" /> <value value="a001a435-4f0e-f011-998b-7c1e5272e500" /> </identifier> <type value="document" /> <timestamp value="2025-03-31T16:45:17.089+00:00" /> <entry> <fullUrl value="urn:uuid:a001a435-4f0e-f011-998b-7c1e5272e500" /> <resource> <Composition> <language value="en" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml" lang="en" xml:lang="en">Labelling</div> </text> <status value="final" /> <type> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/100000155531" /> <code value="100000155535" /> <display value="Labelling" /> </coding> </type> <date value="2025-03-31" /> <author> <identifier> <value value="[ INACTIVE ] 123Ratio Sp. z o.o." /> </identifier> </author> <title value="Labelling" /> <section id="a201a435-4f0e-f011-998b-7c1e5272e500"> <title value="LABELLING" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029861" /> <display value="LABELLING" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="a401a435-4f0e-f011-998b-7c1e5272e500"> <title value="PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}" /> <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> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="a601a435-4f0e-f011-998b-7c1e5272e500"> <title value="1. NAME OF THE MEDICINAL PRODUCT" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029863" /> <display value="1. NAME OF THE MEDICINAL PRODUCT" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="a701a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="a901a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="ac01a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="ae01a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b001a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b201a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b401a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b601a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="b801a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="ba01a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="bb01a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="be01a435-4f0e-f011-998b-7c1e5272e500"> <title value="13. BATCH NUMBER<, DONATION AND PRODUCT CODES>" /> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="c001a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="c201a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="c501a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="c701a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="c901a435-4f0e-f011-998b-7c1e5272e500"> <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"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> </section> </Composition> </resource> </entry> </Bundle> </resource> </entry> <entry> <fullUrl value="urn:uuid:e5f9a62f-4f0e-f011-998b-7c1e5272e500" /> <resource> <Bundle> <id value="e5f9a62f-4f0e-f011-998b-7c1e5272e500" /> <meta> <versionId value="1" /> <lastUpdated value="2025-03-31T16:45:17.089+00:00" /> </meta> <identifier> <system value="http://ema.europa.eu/fhir/epiDocument" /> <value value="e5f9a62f-4f0e-f011-998b-7c1e5272e500" /> </identifier> <type value="document" /> <timestamp value="2025-03-31T16:45:17.089+00:00" /> <entry> <fullUrl value="urn:uuid:e5f9a62f-4f0e-f011-998b-7c1e5272e500" /> <resource> <Composition> <language value="en" /> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml" lang="en" xml:lang="en">Package Leaflet</div> </text> <status value="final" /> <type> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/100000155531" /> <code value="100000155538" /> <display value="Package Leaflet" /> </coding> </type> <date value="2025-03-31" /> <author> <identifier> <value value="[ INACTIVE ] 123Ratio Sp. z o.o." /> </identifier> </author> <title value="Package Leaflet" /> <section id="f2f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="PACKAGE LEAFLET" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029894" /> <display value="PACKAGE LEAFLET" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="f8f9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="1. What X is and what it is used for" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029895" /> <display value="1. What X is and what it is used for" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="fdf9a62f-4f0e-f011-998b-7c1e5272e500"> <title value="2. What you need to know before you <take> <use> X" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029896" /> <display value="2. What you need to know before you [take] [use] X" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="03faa62f-4f0e-f011-998b-7c1e5272e500"> <title value="Do not <take> <use> X" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029897" /> <display value="Do not [take] [use] X" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="05faa62f-4f0e-f011-998b-7c1e5272e500"> <title value="Warnings and precautions" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029898" /> <display value="Warnings and precautions" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="0afaa62f-4f0e-f011-998b-7c1e5272e500"> <title value="Other medicines and X" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029900" /> <display value="Other medicines and X" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="0efaa62f-4f0e-f011-998b-7c1e5272e500"> <title value="Pregnancy <and> <,> breast-feeding <and fertility>" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029902" /> <display value="Pregnancy [and] [,] breast-feeding [and fertility]" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="0ffaa62f-4f0e-f011-998b-7c1e5272e500"> <title value="Driving and using machines" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029903" /> <display value="Driving and using machines" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> <section id="32faa62f-4f0e-f011-998b-7c1e5272e500"> <title value="3. How to <take> <use> X" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029905" /> <display value="3. How to [take] [use] X" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="7cfaa62f-4f0e-f011-998b-7c1e5272e500"> <title value="4. Possible side effects" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029910" /> <display value="4. Possible side effects" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="83faa62f-4f0e-f011-998b-7c1e5272e500"> <title value="Reporting of side effects" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029912" /> <display value="Reporting of side effects" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> <section id="84faa62f-4f0e-f011-998b-7c1e5272e500"> <title value="5. How to store X" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029913" /> <display value="5. How to store X" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="86faa62f-4f0e-f011-998b-7c1e5272e500"> <title value="6. Contents of the pack and other information" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029914" /> <display value="6. Contents of the pack and other information" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> <section id="8afaa62f-4f0e-f011-998b-7c1e5272e500"> <title value="What X contains" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029915" /> <display value="What X contains" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="8cfaa62f-4f0e-f011-998b-7c1e5272e500"> <title value="What X looks like and contents of the pack" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029916" /> <display value="What X looks like and contents of the pack" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="8efaa62f-4f0e-f011-998b-7c1e5272e500"> <title value="Marketing Authorisation Holder and Manufacturer" /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029917" /> <display value="Marketing Authorisation Holder and Manufacturer" /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> <section id="94faa62f-4f0e-f011-998b-7c1e5272e500"> <title value="This leaflet was last revised in <{MM/YYYY}><{month YYYY}>." /> <code> <coding> <system value="http://ema.europa.eu/fhir/CodeSystem/200000029659" /> <code value="200000029919" /> <display value="This leaflet was last revised in [{MM/YYYY}][{month YYYY}]." /> </coding> </code> <text> <status value="generated" /> <div xmlns="http://www.w3.org/1999/xhtml"><div xmlns="http://www.w3.org/1999/xhtml"> </div></div> </text> </section> </section> </section> </Composition> </resource> </entry> </Bundle> </resource> </entry> </Bundle>