Generated Narrative
Resource "cfsb1316794754115" (Language "no")
status: final
type: Package Leaflet (#100000155538)
date: 2015-02-07T13:28:17Z
author: See above (Organization/cfsb6005885654359)
title: TEST PURPOSES ONLY - Suliqua Vulcan ePI
confidentiality: unrestricted
Generated Narrative
Resource "cfsb6005885654359"
identifier: id: ORG-100000789 (OFFICIAL)
active: true
type: Marketing authorisation holder (#/#bus)
name: Sanofi-Aventis Groupe
address: 54 Rue La Boetie Paris 75008 France(WORK)
Generated Narrative
Resource "cfsb2176224411725"
identifier: id: ORG-100001175 (OFFICIAL)
active: true
type: Manufacturer API (#/#220000000033)
name: Sanofi-Aventis Deutschland GmbH
address: Brueningstrasse 50, Industriepark Höchst, 65926 Frankfurt am Main, GERMANY(WORK)
Generated Narrative
Resource "cfsb7719260512249"
identifier: id: ORG-100001175 (OFFICIAL)
active: true
type: Manufacturer Batch release (#/#220000000033)
name: Sanofi-Aventis Deutschland GmbH
address: Brueningstrasse 50, Industriepark Höchst, 65926 Frankfurt am Main, GERMANY(WORK)
Generated Narrative
Resource "cfsb1639015880655"
identifier: id: ORG-100013412 (OFFICIAL)
active: true
type: Medicines Regulatory Authority (#/#220000000033)
name: European Medicines Agency
address: Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands(WORK)
Generated Narrative
Resource "cfsb2023900992766"
identifier: id: EU/1/16/1157/003 (OFFICIAL)
subject: See above (MedicinalProductDefinition/cfsb7123030148537)
type: Marketing Authorisation (#/#100000072062)
description: Suliqua 100 units/ml + 33 microgram/ml solution for injection in x3 pre-filled pens
region: European Union (unknown#eu)
status: Active ( PublicationStatus#active)
statusDate: 2017-01-11T13:28:17Z
validityPeriod: 2017-01-11T13:28:17Z --> (ongoing)
holder: See above (Organization/cfsb6005885654359)
regulator: See above (Organization/cfsb1639015880655)
Generated Narrative
Resource "cfsb7123030148537"
identifier: id: EU/1/16/1157/003 (OFFICIAL)
type: Marketing Authorisation (#/#100000072062)
domain: Human use (#/#100000000012)
version: 1
status: Active ( PublicationStatus#active)
statusDate: 2015-02-07T13:28:17Z
description: Suliqua 100 units/ml + 33 microgram/ml solution for injection in a pre-filled pen: Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 33 micrograms lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide
route: Subcutaneous use (#/#100000073633)
indication: 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.
legalStatusOfSupply: Medicinal product subject to medical prescription (#/#100000072084)
classification: insulin glargine and lixisenatide (#A10AE54), Diabetes mellitus inadequate control (#/#100000019249)
name
productName: Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen
type: Full name (#/#220000000001)
NameParts
- Part Type * Solution for injection Pharmaceutical dose form part (#/#220000000005) CountryLanguages
- Country Jurisdiction Language * European Union (unknown#eu) European Union (unknown#eu) English ( Tags for the Identification of Languages#en)
Generated Narrative
Resource "cfsb5595996591065"
identifier: id: EU/1/16/1157/003 (OFFICIAL)
name: 3 ml cartridge (glass) in a pre-filled pen
type: Chemical Medicinal Product (#/#100000155527)
status: Active ( PublicationStatus#active)
statusDate: 2015-02-07T13:28:17Z
containedItemQuantity: 3 ml
description: 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.
copackagedIndicator: false
manufacturer: See above (Organization/cfsb2176224411725)
- | Identifier | Type | Quantity | Material |
* | id: EU/1/16/1157/003 (OFFICIAL) | Pre-filled pen (#/#100000073543) | 3 | Glass type I (#/#200000003204) |
Generated Narrative
Resource "cfsb5880516529064"
identifier: id: TBD (OFFICIAL)
status: active
formOf: See above (MedicinalProductDefinition/cfsb7123030148537)
administrableDoseForm: Solution for injection (#100000073863)
unitOfPresentation: Pen (#/#200000002135)
producedFrom: See above (ManufacturedItemDefinition/cfsb7089233601948)
routeOfAdministration
code: Subcutaneous use (#100000073633)
TargetSpecies
- Code * Human (#/#100000109093)
Generated Narrative
Resource "cfsb7089233601948"
identifier: id: EU/1/16/1157/003 (OFFICIAL)
status: active
manufacturedDoseForm: Solution (#/#200000002007)
unitOfPresentation: Pen (#/#200000002135)
manufacturer: See above (Organization/cfsb2176224411725)
Generated Narrative
Resource "cfsb3768802370375"
identifier: id: 2ZM8CX04RZ (OFFICIAL)
status: active
role: active (#/#00000072072)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Strengths
- Presentation[x] Basis * 100 units/ml active ingredient - basis of strength (v3-RoleClassIngredientEntity#ACTIB)
Generated Narrative
Resource "cfsb8724428384435"
identifier: id: 74O62BB01U (OFFICIAL)
status: active
role: active (#/#00000072072)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Strengths
- Presentation[x] Basis * 50 ug/ml active ingredient - basis of strength (v3-RoleClassIngredientEntity#ACTIB)
Generated Narrative
Resource "cfsb8364716455502"
identifier: id: 74O62BB01U (OFFICIAL)
status: active
role: active (#/#00000072072)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Strengths
- Presentation[x] Basis * 33 ug/ml active ingredient - basis of strength (v3-RoleClassIngredientEntity#ACTIB)
Generated Narrative
Resource "cfsb7644964356957"
identifier: id: PDC6A3C0OX (OFFICIAL)
status: active
role: Excipient (#/#100000072082)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource "cfsb8873568628101"
identifier: id: AE28F7PNPL (OFFICIAL)
status: active
role: Excipient (#/#100000072082)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource "cfsb7194634205639"
identifier: id: GGO4Y809LO (OFFICIAL)
status: active
role: Excipient (#/#100000072082)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource "cfsb9561966749493"
identifier: id: 86Q357L16B (OFFICIAL)
status: active
role: Excipient (#/#100000072082)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource "cfsb1268193754623"
identifier: id: QTT17582CB (OFFICIAL)
status: active
role: Excipient (#/#100000072082)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource "cfsb3286639616821"
identifier: id: 55X04QC32I (OFFICIAL)
status: active
role: Excipient (#/#100000072082)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource "cfsb7034777237464"
identifier: id: 059QF0KO0R (OFFICIAL)
status: active
role: Excipient (#/#100000072082)
allergenicIndicator: false
- | Manufacturer |
* | See above (Organization/cfsb2176224411725) |
substance
Generated Narrative
Resource "cfsb4325643431772"
identifier: id: Hypersensitivity reaction (OFFICIAL)
type: contraindication
subject:
Generated Narrative
Resource "cfsb8699684597483"
identifier: id: Type 2 diabetes mellitus (OFFICIAL)
type: indication
subject: