show codes show debug x
Task id=task-application fullUrl=(none)
Code: id=(none) fullUrl=(none)Variation Type IB [(100000155692)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Identifier: EMEA/H/C/002345 (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.2.a - SAFETY, EFFICACY, PHARMACOVIGILANCE CHANGES - HUMAN AND VETERINARY MEDICINAL PRODUCTS - Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH [(C.I.2.a)] (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: IB [(typeIB)] (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: IB [(typeIBapplicable)] (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: documentations [(documentationsapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Revised product information. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
Input
Type: Attached to the cover letter of the variation application: EMA/NCA request, if applicable. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: The EMA request (dated 26 October 2020) is attached to the Application Form as Annex 2.
Condition Applies: true
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.2.a - SAFETY, EFFICACY, PHARMACOVIGILANCE CHANGES - HUMAN AND VETERINARY MEDICINAL PRODUCTS - Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product - Implementation of change(s) for which no new additional data is required to be submitted by the MAH [(C.I.2.a)] (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: IB [(typeIB)] (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: IB [(typeIBapplicable)] (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: documentations [(documentationsapplicable)] (https://spor.ema.europa.eu/v1/lists/100000145688-temp)
Input
Type: Revised product information. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
Input
Type: Attached to the cover letter of the variation application: EMA/NCA request, if applicable. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: The EMA request (dated 10 November 2020) is attached to the Application Form as Annex 3.
Condition Applies: true
Input
Type: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
Focus: Levetiracetam SUN (MedicinalProductDefinition[id=variationProduct-1-1-1])
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: Change concern [(change-concern)] (https://spor.ema.europa.eu/v1/lists/example/variation-parameter-tbc)
Value: id=(none) fullUrl=(none)safety [(safety)] (https://spor.ema.europa.eu/v1/lists/example/change-concern-type-tbc)
Input
Type: Change concern [(change-concern)] (https://spor.ema.europa.eu/v1/lists/example/variation-parameter-tbc)
Value: id=(none) fullUrl=(none)followingUrgentSafetyRestriction [(followingUrgentSafetyRestriction)] (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 [(100000155692)] (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: On 23 July 2020 the CHMP adopted a variation to the Marketing Authorisation for Wonderdrug WS1827.The CHMP adopted m
Input
Type: Other Applications [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: None.
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-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: 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: submitted [(100000002345-temp-submitted)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
For
Sun Pharmaceutical Industries Europe B.V. LOC-100001640 (https://spor.ema.europa.eu/v1/locations)
Requested by
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100001121 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sun Pharmaceutical Industries Europe B.V.
email: kissa.koira@slimia.com
Phone: +31 23 568 1234
Address:
Polarisavenue 87
Hoofddorp
2132 JH
Netherlands (Netherlands [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001640 (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
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: 2020-12-22
By
Role id=signature-person-id fullUrl=(none) - id=(none) fullUrl=(none)Manager Regulatory Affairs [(tbc)] (https://spor.ema.europa.eu/v1/lists/100000154441)
Practitioner id=signature-practitioner-id fullUrl=(none)
Name: Mrs Kissa Koira
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100001121 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sun Pharmaceutical Industries Europe B.V.
email: kissa.koira@slimia.com
Phone: +31 23 568 1234
Address:
Polarisavenue 87
Hoofddorp
2132 JH
Netherlands (Netherlands [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001640 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recorded date: 2020-12-22
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: Levetiracetam SUN
Invented name part: Levetiracetam SUN
Pharmaceutical dose form name part: Concentrate for solution for infusion
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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Concentrate for solution for infusion [(100000073871)] (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
Authorisation id=(none) fullUrl=(none)
Type: Extended Data Exclusivity/Marked Protection [(220000000077TODO-)] (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-100001121 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sun Pharmaceutical Industries Europe B.V.
email: kissa.koira@slimia.com
Phone: +31 23 568 1234
Address:
Polarisavenue 87
Hoofddorp
2132 JH
Netherlands (Netherlands [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001640 (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: EU/1/11/841/001 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
Sun Pharmaceutical Industries Europe B.V. LOC-100001640 (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 IB [(100000155692)] (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: 2020-12-22
Based on: C.I.2.a
Based on: C.I.2.a
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Please refer to Annex 4."
New data: "Please refer to Annex 4."
Old data:
Reference: Organization/present-contact-1-org-id, LOC-100000XXX (https://spor.ema.europa.eu/v1/locations)
New data:
Reference: Organization/proposed-contact-1-org-id, 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-100001121 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Sun Pharmaceutical Industries Europe B.V.
email: kissa.koira@slimia.com
Phone: +31 23 568 1234
Address:
Polarisavenue 87
Hoofddorp
2132 JH
Netherlands (Netherlands [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100001640 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))