show codes show debug x
Task id=task-application fullUrl=(none)
Code: id=(none) fullUrl=(none)Variation Type IA [(100000155690)] (https://spor.ema.europa.eu/v1/lists/100000155688)
Identifier: EMEA/H/C/001234/IG1336 (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Identifier: EMEA/H/C/004321/IG1336 (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Identifier: EMEA/H/C/003412/IG1336 (http://ema.europa.eu/fhir/procedureIdentifierNumber)
Status: requested
Intent: order
Task id=variation-1 fullUrl=(none)
Code: A.7 - ADMINISTRATIVE CHANGES - Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)* [(A.7)] (https://spor.ema.europa.eu/v1/lists/100000152091-todo-scope-type)
Status: requested
Intent: order
Date: from 2021-01-28
Input
Type: Procedure Type [(100000000888)] (https://spor.ema.europa.eu/v1/lists/example/procedure-detail-type)
Value: IA [(typeIA)] (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: IA [(typeIAapplicable)] (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: 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: conditions [(conditionsapplicable)] (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: The deletion should not be due to critical deficiencies concerning manufacturing. [(exampleConditionCode)] (https://spor.ema.europa.eu/v1/lists/200000003554)
Value: (no text)
Condition Applies: true
Input
Type: There should at least remain one site/manufacturer, as previously authorised, performing the same function as the one(s) concerned by the deletion. Where applicable at least one manufacturer responsible for batch release that is able to certify the product testing for the purpose of batch release within the EU/EEA remains in the EU/EEA. [(exampleConditionCode)] (https://spor.ema.europa.eu/v1/lists/200000003554)
Value: (no text)
Condition Applies: true
Input
Type: The variation application form should clearly outline the ‘present’ and ‘proposed’ manufacturers as listed in section 2.5 of the application form for marketing authorisations. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
Input
Type: Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate) including revised product information as appropriate. [(exampleDocumentationCode)] (https://spor.ema.europa.eu/v1/lists/200000003964)
Value: (no text)
Condition Applies: true
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: Wonderpill (MedicinalProductDefinition[id=variationProduct-1-1-2])
Focus: Wonderdrug (MedicinalProductDefinition[id=variationProduct-1-1-3])
Focus: Wonderdrug (MedicinalProductDefinition[id=variationProduct-1-1-4])
Focus: WonderMed (MedicinalProductDefinition[id=variationProduct-1-1-5])
Focus: WonderMed (MedicinalProductDefinition[id=variationProduct-1-1-6])
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: 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 IA [(100000155690)] (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 1A, A.7 - BREXIT-related UK batch release site deletionIn addition, the opportunity is taken to make some corrections of typo in local language product information files. The changes do not change the scientific content of the previously approved 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: 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: 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
Medicines Evaluation Board LOC-100000046 (https://spor.ema.europa.eu/v1/locations)
Requested by
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (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: 2021-01-28
By
Role id=signature-person-id fullUrl=(none) - id=(none) fullUrl=(none)Project lead consulting [(tbc)] (https://spor.ema.europa.eu/v1/lists/100000154441)
Practitioner id=signature-practitioner-id fullUrl=(none)
Name: Mrs Contact Person
Organization id=applicant-org-id fullUrl=(none)
Identifier: ORG-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Recorded date: 2021-01-28
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: Concentrate and solvent for 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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Concentrate and solvent for suspension for injection [(100000073990)] (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
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-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (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/1/11/1111/001 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
MEB LOC-100000046 (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 IA [(100000155690)] (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: 2021-01-28
Based on: A.7
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (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: Wonderpill
Invented name part: Wonderpill
Pharmaceutical dose form name part: Concentrate and solvent for 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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Concentrate and solvent for suspension for injection [(100000073990)] (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: EU/1/11/1111/002 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
MEB LOC-100000046 (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 IA [(100000155690)] (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: 2021-01-28
Based on: A.7
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (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: Wonderdrug
Invented name part: Wonderdrug
Pharmaceutical dose form name part: Concentrate and solvent for 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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Concentrate and solvent for suspension for injection [(100000073990)] (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: EU/1/22/2222/001 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
MEB LOC-100000046 (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 IA [(100000155690)] (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: 2021-01-28
Based on: A.7
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-4 fullUrl=(none)
Name: Wonderdrug
Invented name part: Wonderdrug
Pharmaceutical dose form name part: Concentrate and solvent for 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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Concentrate and solvent for suspension for injection [(100000073990)] (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-1-4-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/22/2222/002 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
MEB LOC-100000046 (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 IA [(100000155690)] (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: 2021-01-28
Based on: A.7
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-5 fullUrl=(none)
Name: WonderMed
Invented name part: WonderMed
Pharmaceutical dose form name part: Concentrate and solvent for 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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Concentrate and solvent for suspension for injection [(100000073990)] (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-1-5-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/33/3333/001 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
MEB LOC-100000046 (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 IA [(100000155690)] (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: 2021-01-28
Based on: A.7
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Product id=variationProduct-1-1-6 fullUrl=(none)
Name: WonderMed
Invented name part: WonderMed
Pharmaceutical dose form name part: Concentrate and solvent for 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
Administrable version of product id=(none) fullUrl=(none)
Administrable Dose Form: id=(none) fullUrl=(none)Concentrate and solvent for suspension for injection [(100000073990)] (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-1-6-euAuthorisation fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/33/3333/002 (http://ema.europa.eu/fhir/MarketingAuthorizationNumber)
Status: Valid [(100000072099)] (https://spor.ema.europa.eu/v1/lists/100000072049)
Status date: 2016-02-17
Holder
MEB LOC-100000046 (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 IA [(100000155690)] (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: 2021-01-28
Based on: A.7
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-1]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-2]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-3]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-4]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-5]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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)
Target
Resource: MedicinalProductDefinition[id=variationProduct-1-1-6]
Old data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Company Services International Ltd. Ireland"
New data: "Product information: Annex II A. manufacturer of the biological active substance and manufacturers responsible for batch release Annex III B. package leaflet 6. manufacturer Healthcare Ltd. Ireland"
Old data: "3.3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site' "
New data: "3.2.P.3.1 Manufacturer(s) Table 3.2.P.3.1-1: 'QP release site'"
Old data: "Editorial changes: 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
New data: "Editorial changes (indicated in bold below): 1) Product information in CZ and HR: Annex I. Section 6.1 List of excipients Sodium chloride text"
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-100022780 (https://spor.ema.europa.eu/v1/organizationsTODO)
Name: Parexel International (Irl) Limited
email: contact.person@parexel.com
Phone: +3531234
Address:
1 Kilmainham Square
Inchicore Road
Dublin
Ireland (Ireland [(codeTodo)] (https://spor.ema.europa.eu/v1/lists/100000000002))
Location id=(none) fullUrl=(none)
Identifier: LOC-100031480 (https://spor.ema.europa.eu/v1/locations)
Address:
European Union (European Union [(100000000390)] (https://spor.ema.europa.eu/v1/lists/100000000002))