show codes show debug x
Task id=task-application fullUrl=(none)
Code: id=(none) fullUrl=(none)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-temp)
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-temp)
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-temp)
Input
Type: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
Task id=variation-2 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-temp)
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-temp)
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-temp)
Input
Type: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
Task id=variation-3 fullUrl=(none)
Code: C.z - SAFETY, EFFICACY, PHARMACOVIGILANCE CHANGES - Other variation [(C.z)] (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: IBunforeseen [(typeIBun)] (https://spor.ema.europa.eu/v1/lists/100000155688-temp)
Input
Type: Procedure Type Applicable [(100000000889)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IBunforeseen [(typeIBunapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
Focus: Wonderpill (MedicinalProductDefinition[id=variationProduct-1-1-1])
Focus: WonderDrug (MedicinalProductDefinition[id=variationProduct-1-1-2])
Focus: WonderCap (MedicinalProductDefinition[id=variationProduct-1-1-3])
Input
Type: Grouping details [(grouping-code-tbc)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: id=(none) fullUrl=(none)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: id=(none) fullUrl=(none)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: id=(none) fullUrl=(none)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: id=(none) fullUrl=(none)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: id=(none) fullUrl=(none)Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Input
Type: Scope [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: Type of the Variation Application:1) Type II variation C.I.4: Variations related to significant modifications of the Summary of Product Characteristics intended to improve the manufacturing process and the quality of the medicinal product concerned or its active substance(s)”.
Input
Type: Other Applications [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: Not provided as this variation application is a worksharing procedure affecting more than one procedure. This is other applications text.
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-summary, summary
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-manufacturing, manufacturing
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-labelling, labelling
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-package, package
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-mockups, mockups
Input
Type: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-specimens, specimens
Input
Type: noOtherChanges [(100000002345-temp-noOtherChanges)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: conditionsSet [(100000002345-temp-conditionsSet)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: requiredDocuments [(100000002345-temp-requiredDocuments)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: nationalFees [(100000002345-temp-nationalFees)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: submitted [(100000002345-temp-submitted)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
Input
Type: sharing [(100000002345-temp-sharing)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
For
Sanofi Pasteur LOC-100010589 (https://spor.ema.europa.eu/v1/locations)
Requested by
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
↸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
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
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=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recipient
EMA
↸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
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Payment Notice id=(none) fullUrl=(none)
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 second one
Provider
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recipient
EMA
↸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
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
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: not paid
Fee not paid reason: reason for not paying
Provider
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recipient
EMA
↸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
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Payment Notice id=(none) fullUrl=(none)
Identifier: PO Number 2 (https://spor.ema.europa.eu/v1/po-number)
Notice of Payment Created: 2019-09-16
Status: active
Payment status: not paid
Fee not paid reason: reason for not paying 2
Provider
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
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) - id=(none) 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=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
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) - id=(none) 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=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recorded date: 2020-10-28
Target
Resource: Task[id=task-application]
Activity: attest (http://terminology.hl7.org/CodeSystem/iso-21089-lifecycle)
Product id=variationProduct-1-1-1 fullUrl=(none)
Name: Wonderpill
Invented name part: Wonderpill
Pharmaceutical dose form name part: Suspension for injection
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Suspension for injection [(100000073864)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Authorisation id=(none) fullUrl=(none)
Type: Orphan Designation [(220000000062)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: orphan-proc-number (https://spor.ema.europa.eu/v1/orphan-designation-number)
Identifier: register-number (https://spor.ema.europa.eu/v1/orphan-register-number)
Date: from 2021-09-01
Status: granted [(granted)] (https://spor.ema.europa.eu/v1/lists/todoOrphanStatus)
Orphan - Significant Benefit: true
Holder
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Authorisation id=(none) fullUrl=(none)
Type: Orphan Designation [(220000000062)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: orphan-proc-number-2 (https://spor.ema.europa.eu/v1/orphan-designation-number)
Identifier: register-number-2 (https://spor.ema.europa.eu/v1/orphan-register-number)
Date: from 2021-09-02
Status: granted [(granted)] (https://spor.ema.europa.eu/v1/lists/todoOrphanStatus)
Holder
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Authorisation id=(none) fullUrl=(none)
Type: Paediatric Use [(220000000088TODO)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Status: Applied [(applied)] (https://spor.ema.europa.eu/v1/lists/todoAuthorisationStatus)
Holder
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Case
Application
Type: regulationApplies [(regulationApplies)] (https://spor.ema.europa.eu/v1/lists/paediatric-applicaton-type-todo)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Authorisation id=(none) fullUrl=(none)
Type: Extended Data Exclusivity/Marked Protection [(220000000077TODO-1)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Status: Applied [(applied)] (https://spor.ema.europa.eu/v1/lists/todoAuthorisationStatus)
Holder
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-1-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: See Annex A (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Sanofi LOC-100010589 (https://spor.ema.europa.eu/v1/locations)
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2020-10-28
Based on: C.I.4
Based on: C.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-2 fullUrl=(none)
Name: WonderDrug
Invented name part: WonderDrug
Pharmaceutical dose form name part: Suspension for injection
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Suspension for injection [(100000073864)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-2-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: See Annex A (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Sanofi LOC-100010589 (https://spor.ema.europa.eu/v1/locations)
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2020-10-28
Based on: C.I.4
Based on: C.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-3 fullUrl=(none)
Name: WonderCap
Invented name part: WonderCap
Pharmaceutical dose form name part: Suspension for injection
Domain: Human use [(100000000012)] (https://spor.ema.europa.eu/v1/lists/100000000004)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Suspension for injection [(100000073864)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=ra-red-1-blue-1-3-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: See Annex A (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Sanofi LOC-100010589 (https://spor.ema.europa.eu/v1/locations)
Granted by:
Health Products Regulatory Authority LOC-10000032 (https://spor.ema.europa.eu/v1/locations)
Case
Type: Centralised Procedure [(100000155059)] (https://spor.ema.europa.eu/v1/lists/100000154442)
Application
Type: Variation Type II [(100000155693)] (https://spor.ema.europa.eu/v1/lists/100000155688)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Provenance (Change) id=prov-id-1 fullUrl=(none)
Recorded date: 2020-10-28
Based on: C.I.4
Based on: C.z
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
New data: "Please refer to the comparative table for detailed comparison between the present and proposed information."
Old data:
Reference: Organization/present-contact-1-org-id, Present Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, Proposed Company One LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
Activity: UPDATE (http://terminology.hl7.org/CodeSystem/v3-DataOperation)
Agent
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100000788 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sanofi Pasteur
email: billy.bob@company.com
Phone: +33 (0)4 1233455
Address:
Campus Merieux
1541 Avenue Marcel Merieux
Marcy L'Etoile
69280
France (France [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001840 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=related-orphan-variationProduct-0-0-1 fullUrl=(none)
Name: product with orphan status
Invented name part: product with orphan status
Indication(s) text: headache
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Bath additive [(100000073711)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Chewable tablet [(100000073684)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
Product id=related-orphan-variationProduct-0-0-2 fullUrl=(none)
Name: product 2 name
Invented name part: product 2 name
Indication(s) text: broken leg
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Cachet [(100000073659)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
(unknown resource type)
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Found a parent (RegulatedAuthorization/subject, id=(none) fullUrl=(none))
which is linked to this by contained resource.id
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Anticoagulant and preservative solution for blood [(100000073912)] (https://spor.ema.europa.eu/v1/lists/200000000004)
Route of Administration: ()unknown ()
Warning - Found 3 copies of Ingredient DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), HEPATITIS B (RDNA), POLIOMYELITIS (INACT.) AND HAEMOPHILUS TYPE B CONJUGATE VACCINE (ADSORBED)(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1).
Warning - Found 3 copies of Ingredient DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), HEPATITIS B (RDNA), POLIOMYELITIS (INACT.) AND HAEMOPHILUS TYPE B CONJUGATE VACCINE (ADSORBED)(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1).
Warning - Found 3 copies of Ingredient DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), HEPATITIS B (RDNA), POLIOMYELITIS (INACT.) AND HAEMOPHILUS TYPE B CONJUGATE VACCINE (ADSORBED)(id=Ingredient-p1-1)(id=Ingredient-p2-1)(id=Ingredient-p3-1).
Warning - Found 3 copies of RegulatedAuthorization See Annex A(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-2-euAuthorisation)(id=ra-red-1-blue-1-3-euAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization See Annex A(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-2-euAuthorisation)(id=ra-red-1-blue-1-3-euAuthorisation).
Warning - Found 3 copies of RegulatedAuthorization See Annex A(id=ra-red-1-blue-1-1-euAuthorisation)(id=ra-red-1-blue-1-2-euAuthorisation)(id=ra-red-1-blue-1-3-euAuthorisation).