{ "resourceType":"Bundle", "id": "suliqua-gravitate", "identifier": { "system": "https://www.gravitatehealth.eu/sid/doc", "value": "EU/1/16/1157/003" }, "type": "document", "timestamp": "2017-06-23T08:38:00+02:00", "entry": [{ "resource": { "resourceType":"Composition", "id": "cfsb1316794754115", "language": "no", "text": { "status": "generated", "div": "
Generated Narrative
Resource \"cfsb1316794754115\" (Language \"no\")
: final\n status
: Package Leaflet \n type (#100000155538)
: 2015-02-07T13:28:17Z\n date
: \n authorSee above (Organization/cfsb6005885654359)
: TEST PURPOSES ONLY - Suliqua Vulcan ePI\n title
: unrestricted\n confidentiality
Generated Narrative
Resource \"cfsb6005885654359\"
: id: ORG-100000789 (OFFICIAL)\n identifier
: true\n active
: Marketing authorisation holder \n type (#/#bus)
: Sanofi-Aventis Groupe\n name
: 54 Rue La Boetie Paris 75008 France(WORK)\n address
Generated Narrative
Resource \"cfsb2176224411725\"
: id: ORG-100001175 (OFFICIAL)\n identifier
: true\n active
: Manufacturer API \n type (#/#220000000033)
: Sanofi-Aventis Deutschland GmbH\n name
: Brueningstrasse 50, Industriepark Höchst, 65926 Frankfurt am Main, GERMANY(WORK)\n address
Generated Narrative
Resource \"cfsb7719260512249\"
: id: ORG-100001175 (OFFICIAL)\n identifier
: true\n active
: Manufacturer Batch release \n type (#/#220000000033)
: Sanofi-Aventis Deutschland GmbH\n name
: Brueningstrasse 50, Industriepark Höchst, 65926 Frankfurt am Main, GERMANY(WORK)\n address
Generated Narrative
Resource \"cfsb1639015880655\"
: id: ORG-100013412 (OFFICIAL)\n identifier
: true\n active
: Medicines Regulatory Authority \n type (#/#220000000033)
: European Medicines Agency\n name
: Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands(WORK)\n address
Generated Narrative
Resource \"cfsb2023900992766\"
: id: EU/1/16/1157/003 (OFFICIAL)\n identifier
: \n subjectSee above (MedicinalProductDefinition/cfsb7123030148537)
: Marketing Authorisation \n type (#/#100000072062)
: Suliqua 100 units/ml + 33 microgram/ml solution for injection in x3 pre-filled pens\n description
: European Union \n region (unknown#eu)
: Active \n status (\n PublicationStatus
: 2017-01-11T13:28:17Z\n statusDate
: 2017-01-11T13:28:17Z --> (ongoing)\n validityPeriod
: \n holderSee above (Organization/cfsb6005885654359)
: \n regulatorSee above (Organization/cfsb1639015880655)
Generated Narrative
Resource \"cfsb7123030148537\"
: id: EU/1/16/1157/003 (OFFICIAL)\n identifier
: Marketing Authorisation \n type (#/#100000072062)
: Human use \n domain (#/#100000000012)
: 1\n version
: Active \n status (\n PublicationStatus
: 2015-02-07T13:28:17Z\n statusDate
: Suliqua 100 units/ml + 33 microgram/ml solution for injection in a pre-filled pen:\nEach pre-filled pen contains 300 units of insulin glargine and 100 micrograms lixisenatide in 3 ml solution.\nEach ml contains 100 units of insulin glargine and 33 micrograms lixisenatide.\nEach dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide\n description
: Subcutaneous use \n route (#/#100000073633)
: Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.\n indication
: Medicinal product subject to medical prescription \n legalStatusOfSupply (#/#100000072084)
: insulin glargine and lixisenatide \n classification (#A10AE54) (#/#100000019249)
name
: Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen\n productName
: Full name \n type (#/#220000000001)
NameParts
- Part Type * Solution for injection Pharmaceutical dose form part \n (#/#220000000005) CountryLanguages
- Country Jurisdiction Language * European Union \n (unknown#eu) European Union \n (unknown#eu) English \n (\n Tags for the Identification of Languages
Generated Narrative
Resource \"cfsb5595996591065\"
: id: EU/1/16/1157/003 (OFFICIAL)\n identifier
: 3 ml cartridge (glass) in a pre-filled pen\n name
: Chemical Medicinal Product \n type (#/#100000155527)
: Active \n status (\n PublicationStatus
: 2015-02-07T13:28:17Z\n statusDate
: 3 ml\n containedItemQuantity
: Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen.\n description
: false\n copackagedIndicator
: \n manufacturerSee above (Organization/cfsb2176224411725)
- | Identifier | Type | Quantity | Material |
* | id: EU/1/16/1157/003 (OFFICIAL) | Pre-filled pen \n (#/#100000073543) | 3 | Glass type I \n (#/#200000003204) |
Generated Narrative
Resource \"cfsb5880516529064\"
: id: TBD (OFFICIAL)\n identifier
: active\n status
: \n formOfSee above (MedicinalProductDefinition/cfsb7123030148537)
: Solution for injection \n administrableDoseForm (#100000073863)
: Pen \n unitOfPresentation (#/#200000002135)
: \n producedFromSee above (ManufacturedItemDefinition/cfsb7089233601948)
routeOfAdministration
: Subcutaneous use \n code (#100000073633)
TargetSpecies
- Code * Human \n (#/#100000109093)
Generated Narrative
Resource \"cfsb7089233601948\"
: id: EU/1/16/1157/003 (OFFICIAL)\n identifier
: active\n status
: Solution \n manufacturedDoseForm (#/#200000002007)
: Pen \n unitOfPresentation (#/#200000002135)
: \n manufacturerSee above (Organization/cfsb2176224411725)
Generated Narrative
Resource \"cfsb3768802370375\"
: id: 2ZM8CX04RZ (OFFICIAL)\n identifier
: active\n status
: active \n role (#/#00000072072)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Strengths
- Presentation[x] Basis * 100 units/ml active ingredient - basis of strength \n (v3-RoleClassIngredientEntity#ACTIB)
Generated Narrative
Resource \"cfsb8724428384435\"
: id: 74O62BB01U (OFFICIAL)\n identifier
: active\n status
: active \n role (#/#00000072072)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Strengths
- Presentation[x] Basis * 50 ug/ml active ingredient - basis of strength \n (v3-RoleClassIngredientEntity#ACTIB)
Generated Narrative
Resource \"cfsb8364716455502\"
: id: 74O62BB01U (OFFICIAL)\n identifier
: active\n status
: active \n role (#/#00000072072)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Strengths
- Presentation[x] Basis * 33 ug/ml active ingredient - basis of strength \n (v3-RoleClassIngredientEntity#ACTIB)
Generated Narrative
Resource \"cfsb7644964356957\"
: id: PDC6A3C0OX (OFFICIAL)\n identifier
: active\n status
: Excipient \n role (#/#100000072082)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource \"cfsb8873568628101\"
: id: AE28F7PNPL (OFFICIAL)\n identifier
: active\n status
: Excipient \n role (#/#100000072082)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource \"cfsb7194634205639\"
: id: GGO4Y809LO (OFFICIAL)\n identifier
: active\n status
: Excipient \n role (#/#100000072082)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource \"cfsb9561966749493\"
: id: 86Q357L16B (OFFICIAL)\n identifier
: active\n status
: Excipient \n role (#/#100000072082)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource \"cfsb1268193754623\"
: id: QTT17582CB (OFFICIAL)\n identifier
: active\n status
: Excipient \n role (#/#100000072082)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource \"cfsb3286639616821\"
: id: 55X04QC32I (OFFICIAL)\n identifier
: active\n status
: Excipient \n role (#/#100000072082)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource \"cfsb7034777237464\"
: id: 059QF0KO0R (OFFICIAL)\n identifier
: active\n status
: Excipient \n role (#/#100000072082)
: false\n allergenicIndicator
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource \"cfsb4325643431772\"
: id: Hypersensitivity reaction (OFFICIAL)\n identifier
: contraindication\n type
: \n subject
Generated Narrative
Resource \"cfsb8699684597483\"
: id: Type 2 diabetes mellitus (OFFICIAL)\n identifier
: indication\n type
: \n subject