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
InputType: 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)
InputType: 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)
InputType: 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)
InputType: Revised product information. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
InputType: 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
InputType: 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
InputType: 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)
InputType: 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)
InputType: 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)
InputType: Revised product information. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
InputType: 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
InputType: Article 5 [(exampleArticle5Code)] (https://spor.ema.europa.eu/v1/lists/900000003554-dummy)
Value: true
Focus:
Levetiracetam SUN (MedicinalProductDefinition[id=
variationProduct-1-1-1])
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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)
InputType: 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
InputType: Other Applications [(100000000999-example)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: None.
InputType: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-summary, summary
InputType: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-labelling, labelling
InputType: Annexed Documents [(100000000776)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Reference: DocumentReference/doc-ref-package, package
InputType: noOtherChanges [(100000002345-temp-noOtherChanges)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
InputType: conditionsSet [(100000002345-temp-conditionsSet)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
InputType: submitted [(100000002345-temp-submitted)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: true
ForSun Pharmaceutical Industries Europe B.V. LOC-100001640 (https://spor.ema.europa.eu/v1/locations)
Requested byOrganization 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
ByRole 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
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)
HolderOrganization 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
HolderSun 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)
AgentOrganization 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))