{ "resourceType" : "Bundle", "id" : "08f553cb-1404-4972-bf14-2023a5f59955", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-bundle"] }, "type" : "collection", "entry" : [{ "fullUrl" : "http://fhir.epl.bag.admin.ch/CHIDMP/MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet", "resource" : { "resourceType" : "MedicinalProductDefinition", "id" : "Cuprior-150mg-Filmcoatedtablet", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-medicinalproductdefinition"] }, "text" : { "status" : "extensions", "div" : "

Generated Narrative: MedicinalProductDefinition Cuprior-150mg-Filmcoatedtablet

Profile: MedicinalProductDefinition

CH SMC - Authorized Dose Form: Film-coated tablet

identifier: Medical Product Identifier/CH-01100726-0677190010000

indication:

Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.

\n

legalStatusOfSupply: Medicinal product subject to medical or veterinary prescription (B)

additionalMonitoringIndicator: No Warning

pediatricUseIndicator: Authorised for the treatment in children

classification: gilteritinib, NA KAS art. 12 para. 5 TPLO, Synthetic, Originator product, 07. STOFFWECHSEL, 07.99. Varia

attachedDocument:

name

productName: Cuprior 150 mg, Filmtabletten

type: FOPH Medicinal Product Name

Usages

-CountryLanguage
*SwitzerlandGerman (Switzerland)
" }, "extension" : [{ "url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm", "valueCodeableConcept" : { "coding" : [{ "system" : "http://standardterms.edqm.eu", "code" : "10221000", "display" : "Film-coated tablet" }] } }], "identifier" : [{ "system" : "http://fhir.ch/ig/ch-epl/sid/mpid", "value" : "CH-01100726-0677190010000" }], "indication" : "Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.", "legalStatusOfSupply" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply", "code" : "756005022003", "display" : "Medicinal product subject to medical or veterinary prescription (B)" }] }, "additionalMonitoringIndicator" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator", "code" : "756005001003", "display" : "No Warning" }] }, "pediatricUseIndicator" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator", "code" : "756005003001", "display" : "Authorised for the treatment in children" }] }, "classification" : [{ "coding" : [{ "system" : "http://www.whocc.no/atc", "code" : "L01EX13" }] }, { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-category", "code" : "756005021001", "display" : "NA KAS art. 12 para. 5 TPLO" }] }, { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode", "code" : "756005004001", "display" : "Synthetic" }] }, { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type", "code" : "756001003002", "display" : "Originator product" }] }, { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus", "code" : "070000", "display" : "07. STOFFWECHSEL" }] }, { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus", "code" : "079900", "display" : "07.99. Varia" }] }], "attachedDocument" : [{ "reference" : "DocumentReference/DocRef-FI-Cuprior" }, { "reference" : "DocumentReference/DocRef-PI-Cuprior" }], "name" : [{ "productName" : "Cuprior 150 mg, Filmtabletten", "type" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-medicinal-product-name-type", "code" : "FOPH", "display" : "FOPH Medicinal Product Name" }] }, "usage" : [{ "country" : { "coding" : [{ "system" : "urn:iso:std:iso:3166", "code" : "CH", "display" : "Switzerland" }] }, "language" : { "coding" : [{ "system" : "urn:ietf:bcp:47", "code" : "de-CH", "display" : "German (Switzerland)" }] } }] }] } }, { "fullUrl" : "http://fhir.epl.bag.admin.ch/CHIDMP/DocumentReference/DocRef-FI-Cuprior", "resource" : { "resourceType" : "DocumentReference", "id" : "DocRef-FI-Cuprior", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"] }, "language" : "de-CH", "text" : { "status" : "generated", "div" : "

Generated Narrative: DocumentReference DocRef-FI-Cuprior

Language: de-CH

Profile: DocumentReference

identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-abc-123

status: Current

type: Information for healthcare professionals

date: 2020-09-01 00:00:00+0000

content

Attachments

-Url
*https://swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67719&supportMultipleResults=1
" }, "identifier" : [{ "system" : "http://fhir.ch/ig/ch-epl/sid/attno", "value" : "123456789-initial submission-Example-abc-123" }], "status" : "current", "type" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type", "code" : "756005007001", "display" : "Information for healthcare professionals" }] }, "date" : "2020-09-01T00:00:00Z", "content" : [{ "attachment" : { "url" : "https://swissmedicinfo.ch/showText.aspx?textType=FI&lang=DE&authNr=67719&supportMultipleResults=1" } }] } }, { "fullUrl" : "http://fhir.epl.bag.admin.ch/CHIDMP/DocumentReference/DocRef-PI-Cuprior", "resource" : { "resourceType" : "DocumentReference", "id" : "DocRef-PI-Cuprior", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-documentreference"] }, "language" : "de-CH", "text" : { "status" : "generated", "div" : "

Generated Narrative: DocumentReference DocRef-PI-Cuprior

Language: de-CH

Profile: DocumentReference

identifier: Application / Assessment Tracking Number/123456789-initial submission-Example-abc-321

status: Current

type: Patient Information

date: 2020-09-01 00:00:00+0000

content

Attachments

-Url
*https://swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67719&supportMultipleResults=1
" }, "identifier" : [{ "system" : "http://fhir.ch/ig/ch-epl/sid/attno", "value" : "123456789-initial submission-Example-abc-321" }], "status" : "current", "type" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-attached-document-type", "code" : "756005007002", "display" : "Patient Information" }] }, "date" : "2020-09-01T00:00:00Z", "content" : [{ "attachment" : { "url" : "https://swissmedicinfo.ch/showText.aspx?textType=PI&lang=DE&authNr=67719&supportMultipleResults=1" } }] } }, { "fullUrl" : "http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/MA-6771901", "resource" : { "resourceType" : "RegulatedAuthorization", "id" : "MA-6771901", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"] }, "text" : { "status" : "generated", "div" : "

Generated Narrative: RegulatedAuthorization MA-6771901

Profile: RegulatedAuthorization

identifier: Marketing Authorisation Number/6771901

subject: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia

type: Marketing Authorisation

region: Switzerland

status: valid

statusDate: 2021-01-21

holder: Organization Curatis AG

regulator: Organization Swissmedic Swiss Agency for Therapeutic Products

Generated Narrative: Organization #holder-Curatis-AG

Profile: Organization

identifier: Swissmedic Location Identifier/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007

name: Curatis AG

Generated Narrative: Organization #regulator-SMC

Profile: Organization

identifier: LOC Identifier/100010911, GLN Identifier/7601001398511

name: Swissmedic Swiss Agency for Therapeutic Products

" }, "contained" : [{ "resourceType" : "Organization", "id" : "holder-Curatis-AG", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"] }, "identifier" : [{ "system" : "https://www.swissmedic.ch/fhir/identifier/locations", "value" : "01100726" }, { "system" : "https://spor.ema.europa.eu/v1/locations", "value" : "100082791" }, { "system" : "urn:oid:2.51.1.3", "value" : "7640109110007" }], "name" : "Curatis AG" }, { "resourceType" : "Organization", "id" : "regulator-SMC", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"] }, "identifier" : [{ "system" : "https://spor.ema.europa.eu/v1/locations", "value" : "100010911" }, { "system" : "urn:oid:2.51.1.3", "value" : "7601001398511" }], "name" : "Swissmedic Swiss Agency for Therapeutic Products" }], "identifier" : [{ "system" : "http://fhir.ch/ig/ch-epl/sid/authno", "value" : "6771901" }], "subject" : [{ "reference" : "MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet" }], "type" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type", "code" : "756000002001", "display" : "Marketing Authorisation" }] }, "region" : [{ "coding" : [{ "system" : "urn:iso:std:iso:3166", "code" : "CH", "display" : "Switzerland" }] }], "status" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status", "code" : "756005023007", "display" : "valid" }] }, "statusDate" : "2021-01-21", "holder" : { "reference" : "#holder-Curatis-AG" }, "regulator" : { "reference" : "#regulator-SMC" } } }, { "fullUrl" : "http://fhir.epl.bag.admin.ch/CHIDMP/PackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet", "resource" : { "resourceType" : "PackagedProductDefinition", "id" : "PMP-Cuprior-150mg-Filmcoatedtablet", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-packagedproductdefinition"] }, "text" : { "status" : "generated", "div" : "

Generated Narrative: PackagedProductDefinition PMP-Cuprior-150mg-Filmcoatedtablet

Profile: PackagedProductDefinition

identifier: Clinical Product Identifier/CH-01100726-0677190010000-0001

packageFor: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia

containedItemQuantity: 72 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')

description:

CUPRIOR Filmtabl 150 mg 72 Stk

\n

LegalStatusOfSupplies

-Code
*Medicinal product subject to medical or veterinary prescription (B)

packaging

identifier: Global Trade Item Number/7680677190018

type: Box

quantity: 1

ShelfLifeStorages

-TypePeriod[x]SpecialPrecautionsForStorage
*Shelf life of the medicinal product as packaged for saleNo display for Duration (value: 36; unit: month; system: http://unitsofmeasure.org; code: mo)Do not store above 30°C

Characteristics

-TypeValue[x]
*Package Size TypeModal pack
" }, "identifier" : [{ "system" : "http://fhir.ch/ig/ch-epl/sid/pcid", "value" : "CH-01100726-0677190010000-0001" }], "packageFor" : [{ "reference" : "MedicinalProductDefinition/Cuprior-150mg-Filmcoatedtablet" }], "containedItemQuantity" : [{ "value" : 72, "unit" : "Tablet", "system" : "http://standardterms.edqm.eu", "code" : "15054000" }], "description" : "CUPRIOR Filmtabl 150 mg 72 Stk", "legalStatusOfSupply" : [{ "code" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-legal-status-of-supply", "code" : "756005022003", "display" : "Medicinal product subject to medical or veterinary prescription (B)" }] } }], "packaging" : { "identifier" : [{ "system" : "urn:oid:2.51.1.1", "value" : "7680677190018" }], "type" : { "coding" : [{ "system" : "http://standardterms.edqm.eu", "code" : "30009000", "display" : "Box" }] }, "quantity" : 1, "shelfLifeStorage" : [{ "type" : { "coding" : [{ "system" : "http://spor.ema.europa.eu/v1/lists/100000073343", "code" : "100000073403", "display" : "Shelf life of the medicinal product as packaged for sale" }] }, "periodDuration" : { "value" : 36, "unit" : "month", "system" : "http://unitsofmeasure.org", "code" : "mo" }, "specialPrecautionsForStorage" : [{ "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-special-precautions-for-storage", "code" : "756005042009", "display" : "Do not store above 30°C" }] }] }] }, "characteristic" : [{ "type" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-other-characteristics-type", "code" : "756000003001", "display" : "Package Size Type" }] }, "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-other-characteristics-packaged-item", "code" : "756005041001", "display" : "Modal pack" }] } }] } }, { "fullUrl" : "http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/MA-67719001", "resource" : { "resourceType" : "RegulatedAuthorization", "id" : "MA-67719001", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"] }, "text" : { "status" : "generated", "div" : "

Generated Narrative: RegulatedAuthorization MA-67719001

Profile: RegulatedAuthorization

identifier: Marketing Authorisation Number/67719001

subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01100726-0677190010000-0001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk

type: Marketing Authorisation

region: Switzerland

status: valid

statusDate: 2021-01-21

holder: Organization Curatis AG

regulator: Organization Swissmedic Swiss Agency for Therapeutic Products

Generated Narrative: Organization #holder-Curatis-AG

Profile: Organization

identifier: Swissmedic Location Identifier/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007

name: Curatis AG

Generated Narrative: Organization #regulator-SMC

Profile: Organization

identifier: LOC Identifier/100010911, GLN Identifier/7601001398511

name: Swissmedic Swiss Agency for Therapeutic Products

" }, "contained" : [{ "resourceType" : "Organization", "id" : "holder-Curatis-AG", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"] }, "identifier" : [{ "system" : "https://www.swissmedic.ch/fhir/identifier/locations", "value" : "01100726" }, { "system" : "https://spor.ema.europa.eu/v1/locations", "value" : "100082791" }, { "system" : "urn:oid:2.51.1.3", "value" : "7640109110007" }], "name" : "Curatis AG" }, { "resourceType" : "Organization", "id" : "regulator-SMC", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"] }, "identifier" : [{ "system" : "https://spor.ema.europa.eu/v1/locations", "value" : "100010911" }, { "system" : "urn:oid:2.51.1.3", "value" : "7601001398511" }], "name" : "Swissmedic Swiss Agency for Therapeutic Products" }], "identifier" : [{ "system" : "http://fhir.ch/ig/ch-epl/sid/authno", "value" : "67719001" }], "subject" : [{ "reference" : "PackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet" }], "type" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type", "code" : "756000002001", "display" : "Marketing Authorisation" }] }, "region" : [{ "coding" : [{ "system" : "urn:iso:std:iso:3166", "code" : "CH", "display" : "Switzerland" }] }], "status" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-authorisation-status", "code" : "756005023007", "display" : "valid" }] }, "statusDate" : "2021-01-21", "holder" : { "reference" : "#holder-Curatis-AG" }, "regulator" : { "reference" : "#regulator-SMC" } } }, { "fullUrl" : "http://fhir.epl.bag.admin.ch/CHIDMP/RegulatedAuthorization/FOPH-21208", "resource" : { "resourceType" : "RegulatedAuthorization", "id" : "FOPH-21208", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"] }, "text" : { "status" : "extensions", "div" : "

Generated Narrative: RegulatedAuthorization FOPH-21208

Profile: RegulatedAuthorization

CH EPL - Reimbursement SL

url

FOPHDossierNumber

value: FOPH Dossier Number/21208

url

status

value: Reimbursed

url

statusDate

value: 2021-08-01

url

listingStatus

value: Listed

url

listingPeriod

value: 2021-08-01 --> (ongoing)

url

firstListingDate

value: 2021-08-01

url

costShare

value: 10

url

gamme

value: Oral

value: CHF3,022.10 (CHF)

type: Ex-factory price

changeType: Price mutation after triennal review of pharmaceuticals

changeDate: 2024-01-01

url

CH EPL - Product Price

value: CHF3,347.10 (CHF)

type: Retail price

changeType: VAT-change

changeDate: 2024-01-01

url

CH EPL - Product Price

subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01100726-0677190010000-0001; containedItemQuantity = 72 Tablet; description = CUPRIOR Filmtabl 150 mg 72 Stk

type: Reimbursement SL

Indications

-ExtensionReference
*ClinicalUseDefinition: type = indication

holder: Organization Curatis AG

Generated Narrative: Organization #holder-Curatis-AG

Profile: Organization

identifier: Swissmedic Location Identifier/01100726, LOC Identifier/100082791, GLN Identifier/7640109110007

name: Curatis AG

" }, "contained" : [{ "resourceType" : "Organization", "id" : "holder-Curatis-AG", "meta" : { "profile" : ["http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"] }, "identifier" : [{ "system" : "https://www.swissmedic.ch/fhir/identifier/locations", "value" : "01100726" }, { "system" : "https://spor.ema.europa.eu/v1/locations", "value" : "100082791" }, { "system" : "urn:oid:2.51.1.3", "value" : "7640109110007" }], "name" : "Curatis AG" }], "extension" : [{ "extension" : [{ "url" : "FOPHDossierNumber", "valueIdentifier" : { "system" : "urn:oid:2.16.756.1", "value" : "21208" } }, { "url" : "status", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-reimbursement-status", "code" : "756001021001", "display" : "Reimbursed" }] } }, { "url" : "statusDate", "valueDate" : "2021-08-01" }, { "url" : "listingStatus", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-listing-status", "code" : "756001002001", "display" : "Listed" }] } }, { "url" : "listingPeriod", "valuePeriod" : { "start" : "2021-08-01" } }, { "url" : "firstListingDate", "valueDate" : "2021-08-01" }, { "url" : "costShare", "valueInteger" : 10 }, { "url" : "gamme", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-gamme", "code" : "756002004001", "display" : "Oral" }] } }, { "extension" : [{ "url" : "value", "valueMoney" : { "value" : 3022.1, "currency" : "CHF" } }, { "url" : "type", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type", "code" : "756002005002", "display" : "Ex-factory price" }] } }, { "url" : "changeType", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change", "code" : "756002006010", "display" : "Price mutation after triennal review of pharmaceuticals" }] } }, { "url" : "changeDate", "valueDate" : "2024-01-01" }], "url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice" }, { "extension" : [{ "url" : "value", "valueMoney" : { "value" : 3347.1, "currency" : "CHF" } }, { "url" : "type", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type", "code" : "756002005001", "display" : "Retail price" }] } }, { "url" : "changeType", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-type-of-price-change", "code" : "756002006008", "display" : "VAT-change" }] } }, { "url" : "changeDate", "valueDate" : "2024-01-01" }], "url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/productPrice" }], "url" : "http://fhir.ch/ig/ch-epl/StructureDefinition/reimbursementSL" }], "subject" : [{ "reference" : "PackagedProductDefinition/PMP-Cuprior-150mg-Filmcoatedtablet" }], "type" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type", "code" : "756000002003", "display" : "Reimbursement SL" }] }, "indication" : [{ "extension" : [{ "extension" : [{ "url" : "status", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-limitationstatus", "code" : "756002071001", "display" : "Limitation Reimbursed" }] } }, { "url" : "statusDate", "valueDate" : "2021-08-01" }, { "url" : "period", "valuePeriod" : { "start" : "2021-08-01" } }, { "url" : "firstLimitationDate", "valueDate" : "2021-08-01" }, { "url" : "limitationIndication", "valueReference" : { "reference" : "ClinicalUseDefinition/LIM-79886009-CUPRIOR" } }, { "extension" : [{ "url" : "value", "valueMoney" : { "value" : 3022.1, "currency" : "CHF" } }, { "url" : "type", "valueCodeableConcept" : { "coding" : [{ "system" : "http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-price-type", "code" : "756002005002", "display" : "Ex-factory price" }] } }, { "url" : "changeType", "valueCodeableConcept" : { "coding" : [{ "system" : 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Profile: ManufacturedItemDefinition

status: Active

manufacturedDoseForm: Film-coated tablet

unitOfPresentation: Tablet

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Generated Narrative: AdministrableProductDefinition PhP-Trientinum-150mg-Filmcoatedtablet

Profile: AdministrableProductDefinition

status: Active

formOf: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia

administrableDoseForm: Film-coated tablet

unitOfPresentation: Tablet

RouteOfAdministrations

-Code
*Oral use
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Generated Narrative: Ingredient Trientinum150

Profile: Ingredient

status: Active

for:

role: Active

substance

Codes

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*Trientine

Strengths

-Presentation[x]
*150 mg (Details: UCUM codemg = 'mg')/1 Tablet (Details: EDQM - Standard Terms code15054000 = 'Tablet')
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Generated Narrative: ClinicalUseDefinition IND-10061091

Profile: ClinicalUseDefinition Indication

type: Indication

subject: MedicinalProductDefinition: extension = Film-coated tablet; identifier = http://fhir.ch/ig/ch-epl/sid/mpid#Medical Product Identifier#CH-01100726-0677190010000; indication = Cuprior wird angewendet zur Behandlung von Morbus Wilson bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter mit Unverträglichkeit gegenüber einer D-Penicillamin-Therapie.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = gilteritinib,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product,07. STOFFWECHSEL,07.99. Varia

indication

DiseaseSymptomProcedures

-Concept
*Wilson's disease

IntendedEffects

-Concept
*therapeutic
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Generated Narrative: ClinicalUseDefinition LIM-79886009-CUPRIOR

type: Indication

indication

DiseaseSymptomProcedures

-Concept
*CUPRIOR wird vergütet zur Behandlung der Kupferspeicherkrankheit (Morbus Wilson) bei Erwachsenen, Jugendlichen und Kindern im Alter von 5 Jahren oder älter, die eine Behandlung mit D-Penicillamin nicht vertragen. Die Behandlung muss von Gastroenterologen oder Hepatologen mit Erfahrung bei der Behandlung von Patienten mit Morbus Wilson initiiert und überwacht werden.

IntendedEffects

-Concept
*therapeutic
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