show codes show debug x
Task id=task-application fullUrl=(none)
Code: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Identifier: EMEA/H/C/XXXX/WS/1965/G (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Status: requested
Intent: order
Date: Next Production Run/Next Printing - false
Task id=variation-1 fullUrl=(none)
Code: C.I.4 - SAFETY, EFFICACY, PHARMACOVIGILANCE CHANGES - HUMAN AND VETERINARY MEDICINAL PRODUCTS - Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, preclinical, clinical or pharmacovigilance data [(C.I.4)] (https://spor.ema.europa.eu/v1/lists/100000152091-todo-scope-type)
Status: requested
Intent: order
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: II [(typeII)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: II [(typeIIapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IIart29 [(typeIIart29applicable)] (https://spor.ema.europa.eu/v1/lists/100000145688)
Focus: Losec Control 20 mg gastro-resistant tablets (MedicinalProductDefinition[id=losec-example-id])
Input
Type: Grouping details [(grouping-code-tbc)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: Grouped Regulatory Activity [(100000155555)] (https://spor.ema.europa.eu/v1/lists/100000155553)
Input
Type: Procedure Type [(120000000888-todo)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: Regulatory Activity subject to a Worksharing Agreement [(100000155556)] (https://spor.ema.europa.eu/v1/lists/100000155553)
Value: true
Input
Type: Change concern [(change-concern)] (https://spor.ema.europa.eu/v1/lists/example/variation-parameter-tbc)
Value: Other [(other)] (https://spor.ema.europa.eu/v1/lists/example/change-concern-type-tbc)
Input
Type: Domain [(100000000777)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: Variation Type IB unforseen (invented) [((unknown))] (https://spor.ema.europa.eu/v1/lists/100000155688)
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: (Link to an SmPC for one or more products)
Input
Type: Declaration - There are no other changes than those identified in this application (except for those addressed in other variations submitted in parallel) [(100000002345-temp-noOtherChanges)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: Declaration - the required documents as specified for the changes concerned have been submitted [(100000002346)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
For
Bayer Limited LOC-100000833 (https://spor.ema.europa.eu/v1/locations)
Requested by
Organization id=applicant-org-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82004
Identifier: ORG-100021611 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Alexion Pharma Nordics AB
email: aa@aa.com
Phone: 1111111
Address:
Stockholms Domkyrkoförs
Vasagatan 7
Stockholm
111 20
Sweden
↸arrow indicates that this points back to the parent Task rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
Payment Notice id=(none) fullUrl=(none)
Identifier: PO Number (https://spor.ema.europa.eu/v1/po-number)
Notice of Payment Created: 2019-09-16
Status: active
Payment status: paid (http://terminology.hl7.org/CodeSystem/paymentstatus)
Fee category: fee category under National rules A
Fee category: fee category under National rules B
Provider
Organization id=applicant-org-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82004
Identifier: ORG-100021611 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Alexion Pharma Nordics AB
email: aa@aa.com
Phone: 1111111
Address:
Stockholms Domkyrkoförs
Vasagatan 7
Stockholm
111 20
Sweden
Recipient
EMA
↸arrow indicates that this points back to the parent Task rather then being linked forwards from it
Provenance (Signature) id=signature-id fullUrl=(none)
Type: Author's Signature [(1.2.840.10065.1.12.1.1)] (urn:iso-astm:E1762-95:2013)
When: 2020-10-28
By
Role id=signature-person-id fullUrl=(none) - Regulatory Product Manager [(tbc)] (https://spor.ema.europa.eu/v1/lists/100000154441)
Practitioner id=signature-practitioner-id fullUrl=(none)
Name: Mrs Bob Billy Billing contact
Organization id=applicant-org-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82004
Identifier: ORG-100021611 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Alexion Pharma Nordics AB
email: aa@aa.com
Phone: 1111111
Address:
Stockholms Domkyrkoförs
Vasagatan 7
Stockholm
111 20
Sweden
Grouping - Confirm authority to sign: true
Type: Coauthor's Signature [(1.2.840.10065.1.12.1.2)] (urn:iso-astm:E1762-95:2013)
When: 2020-10-29
By
Role id=secondary-signature-person-id fullUrl=(none) - etc [(tbc)] (https://spor.ema.europa.eu/v1/lists/100000154441)
Practitioner id=secondary-signature-practitioner-id fullUrl=(none)
Name: mr second signatory
Organization id=applicant-org-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82004
Identifier: ORG-100021611 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Alexion Pharma Nordics AB
email: aa@aa.com
Phone: 1111111
Address:
Stockholms Domkyrkoförs
Vasagatan 7
Stockholm
111 20
Sweden
Recorded date: 2020-10-28
Target
Resource: Task[id=task-application]
Activity: attest (http://terminology.hl7.org/CodeSystem/iso-21089-lifecycle)
Product id=losec-example-id fullUrl=(none)
Name: Losec Control 20 mg gastro-resistant tablets
Invented name part: Losec Control
Strength name part: 20 mg
Pharmaceutical dose form name part: Gastro-resistant tablets
Country: Ireland [(100000000427)] (https://spor.ema.europa.eu/v1/lists/100000000002)
Language: English [(100000072147)] (https://spor.ema.europa.eu/v1/lists/100000072057)
Identifier: IE-100000833-00000003 (http://ema.europa.eu/fhir/mpId)
Identifier: 2215 (http://ema.europa.eu/fhir/eurdId)
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
Authorised Dose Form: Gastro-resistant tablet [(100000073667)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Legal Status of Supply: Medicinal Product not subject to prescription [(100000072076)] (https://spor.ema.europa.eu/v1/lists/100000072051)
Additional Monitoring Indicator: False [(False)] (http://ema.europa.eu/fhir/additionalMonitoringIndicator)
Paediatric Use: medicinal product not authorised for paediatric use [(False)] (http://ema.europa.eu/fhir/paediatricUseIndicator)
Indication(s) text: Losec Control gastro-resistant tablets is indicated for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Characteristic: False (https://ema.europa.eu/fhir/gmo)
Classification: Other [(200000003517)] (https://spor.ema.europa.eu/v1/lists/200000000324)
Classification: Well-established use application (Article 10a of Directive No 2001/83/EC) [(100000116053)] (https://spor.ema.europa.eu/v1/lists/100000116045)
Classification: A02BC01 [(100000093631)] (https://spor.ema.europa.eu/v1/lists/100000093533)
Classification: Chemical [(100000155527)] (https://spor.ema.europa.eu/v1/lists/100000155526)
Manufacturing (Operation)
Operation: Manufacture of active substance [(100000160467)] (https://spor.ema.europa.eu/v1/lists/100000160406)
Date: from 2011-03-03
Manufacturer: ABC (LOC-1000XXXXX (https://spor.ema.europa.eu/v1/locations))
Confidentiality: Confidential [(200000004984)] (https://spor.ema.europa.eu/v1/lists/200000004983)
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Authorisation id=Op216448f82002 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82002
Type: Manufacturing Authorisation [(220000000099)] (https://spor.ema.europa.eu/v1/lists/authorisationTypeExample)
Identifier: 12345 (http://ema.europa.eu/fhir/manufacturingAuthorizationNumber)
Granted by:
ABC LOC1000YYYYY (https://spor.ema.europa.eu/v1/locations)
Manufacturing (Operation)
Operation: Manufacturer responsible for batch certification [(100000160407)] (https://spor.ema.europa.eu/v1/lists/100000160406)
Date: from 2011-03-03
Manufacturer: Corden Pharma GmbH, Germany Otto Hahn Strasse, 68723, Plankstadt DE (LOC-100021495 (https://spor.ema.europa.eu/v1/locations))
Confidentiality: Public [(200000004985)] (https://spor.ema.europa.eu/v1/lists/200000004983)
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Authorisation id=Op216448f82004 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82003
Type: Manufacturing Authorisation [(220000000099)] (https://spor.ema.europa.eu/v1/lists/authorisationTypeExample)
Identifier: DE_BW_01_MIA_2019_0050 (http://ema.europa.eu/fhir/manufacturingAuthorizationNumber)
Date: from 2019-06-21
Granted by:
Regierungspraesidium Tuebingen, Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg LOC-100011003 (https://spor.ema.europa.eu/v1/locations)
Manufacturing (Operation)
Operation: Secondary packaging [(100000160464)] (https://spor.ema.europa.eu/v1/lists/100000160406)
Date: from 2019
Manufacturer: BCD (LOC-1000AAAAA (https://spor.ema.europa.eu/v1/locations))
Confidentiality: Confidential [(200000004984)] (https://spor.ema.europa.eu/v1/lists/200000004983)
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Authorisation id=Op216448f82006 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82004
Type: Manufacturing Authorisation [(220000000099)] (https://spor.ema.europa.eu/v1/lists/authorisationTypeExample)
Identifier: xx_MIA_2019_xx (http://ema.europa.eu/fhir/manufacturingAuthorizationNumber)
Date: from 2019-06
Granted by:
CAB LOC-1000ZZZZZ (https://spor.ema.europa.eu/v1/locations)
Manufacturing (Operation)
Operation: Primary packaging [(100000160463)] (https://spor.ema.europa.eu/v1/lists/100000160406)
Date: from 2011 to 2020-07-29 [Element created] @id=losec-primary-packaging-old-end-date-id
Manufacturer: CBD (LOC-1000BBBBB (https://spor.ema.europa.eu/v1/locations))
Confidentiality: Confidential [(200000004984)] (https://spor.ema.europa.eu/v1/lists/200000004983)
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Authorisation id=Op216448f82008 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82005
Type: Manufacturing Authorisation [(220000000099)] (https://spor.ema.europa.eu/v1/lists/authorisationTypeExample)
Identifier: xx_MIA_2019_xx (http://ema.europa.eu/fhir/manufacturingAuthorizationNumber)
Date: from 2019-06
Granted by:
DCB LOC-1000QQQQQ (https://spor.ema.europa.eu/v1/locations)
Manufacturing (Operation) [Element created] @id=losec-primary-packaging-new-id
Operation: Primary packaging [(100000160463)] (https://spor.ema.europa.eu/v1/lists/100000160406)
Date: from 2020-07-30
Manufacturer: New Manufacturer (LOC-1000CCCC (https://spor.ema.europa.eu/v1/locations))
Confidentiality: Confidential [(200000004984)] (https://spor.ema.europa.eu/v1/lists/200000004983)
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Authorisation id=Op216448f82008 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82005
Type: Manufacturing Authorisation [(220000000099)] (https://spor.ema.europa.eu/v1/lists/authorisationTypeExample)
Identifier: xx_MIA_2019_xx (http://ema.europa.eu/fhir/manufacturingAuthorizationNumber)
Date: from 2019-06
Granted by:
DCB LOC-1000QQQQQ (https://spor.ema.europa.eu/v1/locations)
Contact:
Type: Qualified Person in the EEA for Pharmacovigilance [(100000155057)] (https://spor.ema.europa.eu/v1/lists/100000154441)
Contact:
Type: 200000017719 (http://spor.ema.europa.eu/v1/lists/100000154441)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Package (1 of 3) id=Losec-example-package2-id fullUrl=urn:uuid:c6a838d9-27ca-49b4-a6ba-216448f82013
Identifier: IE-6006100000833-003-001 (http://ema.europa.eu/fhir/pcId)
Language: en
Contained Items: 7 tablets
Description: Polyamide/Aluminium/PVC blister containing 7 tablets
Packaging
Type: Box [(100000073498)] (https://spor.ema.europa.eu/v1/lists/100000073346)
Quantity: 1
Material: Cardboard [(200000003529)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Shelf Life: Shelf life of the medicinal product as packaged for sale [(100000073403)] (https://spor.ema.europa.eu/v1/lists/100000073343)- 3 year
Special Precautions: Do not store above 25 °C [(100000073410)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Special Precautions: Store in the original package [(100000073421)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Special Precautions: in order to protect from moisture [(100000073427)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Packaging
Type: Blister [(100000073496)] (https://spor.ema.europa.eu/v1/lists/100000073346)
Quantity: 1
Material: Polyamid [(200000003209)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Material: Aluminium [(200000003200)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Material: PVC [(200000003222)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Amount: 7 (items within)
↸arrow indicates that this points back to the parent PackagedProductDefinition rather then being linked forwards from it
Found a parent (PackagedProductDefinition/item, id=Losec-example-package2-id fullUrl=urn:uuid:c6a838d9-27ca-49b4-a6ba-216448f82013)
which is linked to this by resource.id
Found a parent (PackagedProductDefinition/item, id=Losec-example-package1-id fullUrl=(none))
which is linked to this by resource.id
Found a parent (PackagedProductDefinition/item, id=Losec-example-package-new-id fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82013)
which is linked to this by resource.id
Manufactured Item id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009
Dose Form: Gastro-resistant tablet [(100000073667)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Unit of presentation: Tablet [(200000002152)] (https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82018 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82010
Role: Active [(100000072072)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Omeprazole magnesium [(100000085918)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: 20.6 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
Reference Substance: Omeprazole [(100000092047)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82019 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82011
Role: Excipient [(100000072082)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Cellulose microcrystalline [(100000078235)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: 50 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82020 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82012
Role: Excipient [(100000072082)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Sucrose [(100000135386)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: between 19 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014) and 20 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Package (2 of 3) id=Losec-example-package1-id fullUrl=(none)
Identifier: IE-6006100000833-003-002 (http://ema.europa.eu/fhir/pcId)
Contained Items: 14 tablets
Description: Polyamide/Aluminium/PVC blister containing 14 tablets
Packaging
Type: Box [(100000073498)] (https://spor.ema.europa.eu/v1/lists/100000073346)
Quantity: 1
Material: Cardboard [(200000003529)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Shelf Life: Shelf life of the medicinal product as packaged for sale [(100000073403)] (https://spor.ema.europa.eu/v1/lists/100000073343)- 3 year
Special Precautions: Do not store above 25 °C [(100000073410)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Special Precautions: Store in the original package [(100000073421)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Special Precautions: in order to protect from moisture [(100000073427)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Packaging
Type: Blister [(100000073496)] (https://spor.ema.europa.eu/v1/lists/100000073346)
Quantity: 1
Material: Polyamid [(200000003209)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Material: Aluminium [(200000003200)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Material: PVC [(200000003222)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Amount: 14 (items within)
↸arrow indicates that this points back to the parent PackagedProductDefinition rather then being linked forwards from it
Found a parent (PackagedProductDefinition/item, id=Losec-example-package2-id fullUrl=urn:uuid:c6a838d9-27ca-49b4-a6ba-216448f82013)
which is linked to this by resource.id
Found a parent (PackagedProductDefinition/item, id=Losec-example-package1-id fullUrl=(none))
which is linked to this by resource.id
Found a parent (PackagedProductDefinition/item, id=Losec-example-package-new-id fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82013)
which is linked to this by resource.id
Manufactured Item id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009
Dose Form: Gastro-resistant tablet [(100000073667)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Unit of presentation: Tablet [(200000002152)] (https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82018 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82010
Role: Active [(100000072072)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Omeprazole magnesium [(100000085918)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: 20.6 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
Reference Substance: Omeprazole [(100000092047)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82019 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82011
Role: Excipient [(100000072082)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Cellulose microcrystalline [(100000078235)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: 50 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82020 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82012
Role: Excipient [(100000072082)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Sucrose [(100000135386)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: between 19 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014) and 20 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Found a parent (Provenance/target, id=prov-id-1 fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82001)
which is linked to this by resource.id
Package (3 of 3) [Resource created] id=Losec-example-package-new-id fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82013
Identifier: IE-6006100000833-003-003 (http://ema.europa.eu/fhir/pcId)
Language: en
Contained Items: 28 tablets
Description: [New package] Polyamide/Aluminium/PVC blister containing 28 tablets
Packaging
Type: Box [(100000073498)] (https://spor.ema.europa.eu/v1/lists/100000073346)
Quantity: 1
Material: Cardboard [(200000003529)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Shelf Life: Shelf life of the medicinal product as packaged for sale [(100000073403)] (https://spor.ema.europa.eu/v1/lists/100000073343)- 3 year
Special Precautions: Do not store above 25 °C [(100000073410)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Special Precautions: Store in the original package [(100000073421)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Special Precautions: in order to protect from moisture [(100000073427)] (https://spor.ema.europa.eu/v1/lists/100000073344)
Packaging
Type: Blister [(100000073496)] (https://spor.ema.europa.eu/v1/lists/100000073346)
Quantity: 1
Material: Polyamid [(200000003209)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Material: Aluminium [(200000003200)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Material: PVC [(200000003222)] (https://spor.ema.europa.eu/v1/lists/200000003199)
Amount: 28 (items within)
↸arrow indicates that this points back to the parent PackagedProductDefinition rather then being linked forwards from it
Found a parent (PackagedProductDefinition/item, id=Losec-example-package2-id fullUrl=urn:uuid:c6a838d9-27ca-49b4-a6ba-216448f82013)
which is linked to this by resource.id
Found a parent (PackagedProductDefinition/item, id=Losec-example-package1-id fullUrl=(none))
which is linked to this by resource.id
Found a parent (PackagedProductDefinition/item, id=Losec-example-package-new-id fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82013)
which is linked to this by resource.id
Manufactured Item id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009
Dose Form: Gastro-resistant tablet [(100000073667)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Unit of presentation: Tablet [(200000002152)] (https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82018 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82010
Role: Active [(100000072072)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Omeprazole magnesium [(100000085918)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: 20.6 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
Reference Substance: Omeprazole [(100000092047)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82019 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82011
Role: Excipient [(100000072082)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Cellulose microcrystalline [(100000078235)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: 50 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82020 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82012
Role: Excipient [(100000072082)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Sucrose [(100000135386)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: between 19 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014) and 20 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent PackagedProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82001
Recorded date: 2021-03-30
Target
Resource: PackagedProductDefinition[id=Losec-example-package-new-id]
Occurred date: 2021-03-29
Reason: B.II.e.5.a Change in the number of units (e.g. tablets, ampoules, etc.) in a pack [(100000152447)] (https://spor.ema.europa.eu/v1/lists/100000152091)
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Role id=applicant-person-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82003 - Variation Applicant
Practitioner id=applicant-practitioner-id fullUrl=(none)
Name: Mr John Applicant
Location id=location-BE fullUrl=(none)
Address:
Belgium
Organization id=applicant-org-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82004
Identifier: ORG-100021611 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Alexion Pharma Nordics AB
email: aa@aa.com
Phone: 1111111
Address:
Stockholms Domkyrkoförs
Vasagatan 7
Stockholm
111 20
Sweden
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Administrable version of product id=apd216448f82024 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82014
Administrable Dose Form: Gastro-resistant tablet [(100000073667)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Unit of Presentation: Tablet [(200000002152)] (https://spor.ema.europa.eu/v1/lists/200000000014)
Route of Administration: Oral use [(100000073619)] (https://spor.ema.europa.eu/v1/lists/100000073345)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82018 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82010
Role: Active [(100000072072)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Omeprazole magnesium [(100000085918)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: 20.6 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
Reference Substance: Omeprazole [(100000092047)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82019 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82011
Role: Excipient [(100000072082)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Cellulose microcrystalline [(100000078235)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: 50 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=mid216448f82017 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82009)
which is linked to this by resource.id
(unknown resource type)
which is linked to this by resource.id
Ingredient id=ing216448f82020 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82012
Role: Excipient [(100000072082)] (https://spor.ema.europa.eu/v1/lists/100000072050)
Substance: Sucrose [(100000135386)] (https://spor.ema.europa.eu/v2/SubstanceDefinition)
Strength:
Presentation Strength: between 19 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014) and 20 milligram(s) (100000110655 https://spor.ema.europa.eu/v1/lists/100000110633) per 1 tablet (200000002152 https://spor.ema.europa.eu/v1/lists/200000000014)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Clinical Use Issue id=cui216448f82025 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82015
Type: indication
Details of indication: Heartburn [(100000026489)] (https://spor.ema.europa.eu/v1/lists/100000000006)
Intended Effect: Treatment [(X)] (https://spor.ema.europa.eu/v1/lists/intendedEffect)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=Ma216448f82010 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82006
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: PA1410/066/001 (http://ema.europa.eu/fhir/marketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Region: Ireland [(100000000427)] (https://spor.ema.europa.eu/v1/lists/100000000002)
Status date: 2016-02-17
Holder
Bayer Limited LOC-100000833 (https://spor.ema.europa.eu/v1/locations)
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Date - dateOfFirstAuthorisation: 2011-12-21
Date - internationalBirthDate: 1987-04-15
Case
Identifier: IE/H/0655/001 (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Type: Mutual Recognition Procedure [(100000155061)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Date: from 2009-10-29 to 2011-03-03
Application IE/H/0655/05/II/0015 (http://ema.europa.eu/fhir/applicationIdentifierNumber)
Type: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Date: 2019-02-17
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-2a fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82002
Recorded date: 2021-03-30
Based on: C.I.4
Target
Resource: MedicinalProductDefinition[id=losec-example-id]
Element: MedicinalProductDefinition.operation.effectiveDate.end[id=losec-primary-packaging-old-end-date-id]
New data: "2020-07-29"
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Role id=applicant-person-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82003 - Variation Applicant
Practitioner id=applicant-practitioner-id fullUrl=(none)
Name: Mr John Applicant
Location id=location-BE fullUrl=(none)
Address:
Belgium
Organization id=applicant-org-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82004
Identifier: ORG-100021611 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Alexion Pharma Nordics AB
email: aa@aa.com
Phone: 1111111
Address:
Stockholms Domkyrkoförs
Vasagatan 7
Stockholm
111 20
Sweden
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-2b fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82006
Recorded date: 2020-10-28
Based on: C.I.4
Based on: B.II.b.1.b Primary packaging site
Target
Resource: MedicinalProductDefinition[id=losec-example-id]
Element: MedicinalProductDefinition.operation[id=losec-primary-packaging-new-id]
New data:
Manufacturing (Operation) [Element created] @id=losec-primary-packaging-new-id
Operation: Primary packaging [(100000160463)] (https://spor.ema.europa.eu/v1/lists/100000160406)
Date: from 2020-07-30
Manufacturer: New Manufacturer (LOC-1000CCCC (https://spor.ema.europa.eu/v1/locations))
Confidentiality: Confidential [(200000004984)] (https://spor.ema.europa.eu/v1/lists/200000004983)
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Found a parent (MedicinalProductDefinition/authorization, id=losec-example-id fullUrl=(none))
which is linked to this by resource.id
Authorisation id=Op216448f82008 fullUrl=urn:uuid:c6a838d9-27ca-49a4-a6ba-216448f82005
Type: Manufacturing Authorisation [(220000000099)] (https://spor.ema.europa.eu/v1/lists/authorisationTypeExample)
Identifier: xx_MIA_2019_xx (http://ema.europa.eu/fhir/manufacturingAuthorizationNumber)
Date: from 2019-06
Granted by:
DCB LOC-1000QQQQQ (https://spor.ema.europa.eu/v1/locations)
Activity: CREATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=urn:uuid:d6a838d9-27ca-49a4-a6ba-216448f82004
Identifier: ORG-100021611 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Alexion Pharma Nordics AB
email: aa@aa.com
Phone: 1111111
Address:
Stockholms Domkyrkoförs
Vasagatan 7
Stockholm
111 20
Sweden
Warning - Found 2 copies of Ingredient equal to(id=ing216448f82018)(id=ing216448f82019).
Warning - Found 2 copies of Ingredient equal to(id=ing216448f82018)(id=ing216448f82019).
Warning - Found 2 copies of Ingredient equal to(id=ing216448f82018)(id=ing216448f82019).
Warning - Found 2 copies of RegulatedAuthorization xx_MIA_2019_xx(id=Op216448f82006)(id=Op216448f82008).
Warning - Found 2 copies of RegulatedAuthorization xx_MIA_2019_xx(id=Op216448f82006)(id=Op216448f82008).
Warning - Found 2 copies of Operation Primary packaging.
Warning - Found 2 copies of Operation Primary packaging.