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Product id=Injectulin-contained fullUrl=(none)
Name: Injectulin
Invented name part: Injectulin
Country: EU (http://ema.europa.eu/fhir/countryCode)
Language: EN (http://ema.europa.eu/fhir/languageCode)
Identifier: {mpid} (http://ema.europa.eu/fhir/MPID)
Legal Status of Supply: Subjecttomedicalprescription (http://ema.europa.eu/fhir/legalstatusofsupply)
Classification: A10AB01 (http://ema.europa.eu/fhir/value)
Manufacturing (Operation)
Operation: Batchrelease (http://ema.europa.eu/fhir/manufacturingOperationType)
Date: from 2011-04-15
Manufacturer:  Injectulin-organization (https://spor.ema.europa.eu/v1/locations)
Found a parent (MedicinalProductDefinition/authorization, id=Injectulin-contained fullUrl=(none))
which is linked to this by resource.id
Authorisation id=RA-1314TZ-d3e94 fullUrl=(none)
Identifier: 1314TZ (http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber)
Granted by:
Injectulin-regulator (https://spor.ema.europa.eu/v1/locations)
Marketing Status
Country: EU (http://ema.europa.eu/fhir/countryCode)
Status:  Marketed (http://ema.europa.eu/fhir/marketingstatus)
Date:      2005-11-20
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Package id=Injectulin-d3e363 fullUrl=(none)
Identifier: {PCID} (http://ema.europa.eu/fhir/pcid)
Description: VIAL.PACK SIZE:5 X 10 ML
Packaging
Type: Carton (http://ema.europa.eu/fhir/packageitemcontainertype)
Quantity: 1
Material: Paperboard (http://ema.europa.eu/fhir/packageItemContainerMaterial)
Manufacturer
Injectulin-manufacturer (https://spor.ema.europa.eu/v1/locations)
Packaging
Type: Vial (http://ema.europa.eu/fhir/packageitemcontainertype)
Quantity: 1
Material: type1colourlessglass (http://ema.europa.eu/fhir/packageItemContainerMaterial)
Shelf Life: ShelfLifeofPackagedMedicinalProduct (http://ema.europa.eu/fhir/shelfLifeTypePlaceHolder)- 2 a
Amount: 10 ml
↸arrow indicates that this points back to the parent PackagedProductDefinition rather then being linked forwards from it
Found a parent (PackagedProductDefinition/item, id=Injectulin-d3e363 fullUrl=(none))
which is linked to this by resource.id
Manufactured Item id=Injectulin-d3e458 fullUrl=(none)
Dose Form: Solutionforinjection (http://ema.europa.eu/fhir/manufactureddoseform)
Unit of presentation: vial (http://ema.europa.eu/fhir/unitofpresentation)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=Injectulin-d3e458 fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e466 fullUrl=(none)
Role: ActiveBase (http://ema.europa.eu/fhir/ingredientRole)
Substance: Insulinhuman (http://ema.europa.eu/fhir/substance)
Strength:
Presentation Strength: 100 IU per 1 ml
Concentration Strength: 100 IU per 1 ml
Manufacturer: Injectulin-manufacturer (https://spor.ema.europa.eu/v1/locations)
Manufacturer: Injectulin-manufacturer (https://spor.ema.europa.eu/v1/locations)
[skipping item Ingredient.specifiedSubstance]
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=Injectulin-d3e458 fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e626 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: WATERFORINJECTION (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=Injectulin-d3e458 fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e647 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: HYDROCHLORICACID (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=Injectulin-d3e458 fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e667 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: METACRESOL (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=Injectulin-d3e458 fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e689 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: SODIUMHYDROXIDE (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent ManufacturedItemDefinition rather then being linked forwards from it
Found a parent (ManufacturedItemDefinition/ingredient, id=Injectulin-d3e458 fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e709 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: GLYCEROL (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Administrable version of product id=Injectulin-d3e745 fullUrl=(none)
Identifier: {PhPID} (http://ema.europa.eu/fhir/phpididentifiersets)
Administrable Dose Form: Solutionforinjection (http://ema.europa.eu/fhir/administrabledoseform)
Route of Administration: ()SUBCUTANEOUSUSE (http://ema.europa.eu/fhir/routeofadministration)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (MedicinalProductDefinition/ingredient, id=Injectulin-contained fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e766 fullUrl=(none)
Role: ActiveBase (http://ema.europa.eu/fhir/ingredientRole)
Substance: InsulinHuman (http://ema.europa.eu/fhir/substance)
Strength:
Presentation Strength: 100 IU per 1 ml
Concentration Strength: 100 IU per 1 ml
[skipping item Ingredient.specifiedSubstance]
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (MedicinalProductDefinition/ingredient, id=Injectulin-contained fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e806 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: SODIUMDIHYDROGENPHOSPHATEDIHYDRATE (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (MedicinalProductDefinition/ingredient, id=Injectulin-contained fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e826 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: WATERFORINJECTION (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (MedicinalProductDefinition/ingredient, id=Injectulin-contained fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e846 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: HYDROCHLORICACID (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (MedicinalProductDefinition/ingredient, id=Injectulin-contained fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e868 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: METACRESOL (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (MedicinalProductDefinition/ingredient, id=Injectulin-contained fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e888 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: SODIUMHYDROXIDE (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent AdministrableProductDefinition rather then being linked forwards from it
Found a parent (MedicinalProductDefinition/ingredient, id=Injectulin-contained fullUrl=(none))
which is linked to this by resource.id
Ingredient id=Injectulin-d3e909 fullUrl=(none)
Role: Inactive (http://ema.europa.eu/fhir/ingredientRole)
Substance: GLYCEROL (http://ema.europa.eu/fhir/substance)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Clinical Use Issue id=Injectulin-d3e25 fullUrl=(none)
Type: contraindication
Details of contraindication: Hypersensitivity (http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure) - Text: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Clinical Use Issue id=Injectulin-d3e951 fullUrl=(none)
Type: indication
Details of indication: Diabetesmellitus (http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure) - Text: Diabetes mellitus where treatment with insulin is required. Injectulin is also suitable for the
treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and
post-operative stabilisation in patients with diabetes mellitus.
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Clinical Use Issue id=Injectulin-d3e965 fullUrl=(none)
Type: indication
Details of indication: intra-andpost-operative\nstabilisation (http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure) - Text: Injectulin is also suitable for the
treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and
post-operative stabilisation in patients with diabetes mellitus.
Co-morbibity: Diabetesmellitus (http://ema.europa.eu/fhir/comorbidity)
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Clinical Use Issue id=Injectulin-d3e982 fullUrl=(none)
Type: indication
Details of indication: hyperglycaemic\ncoma (http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure) - Text: Injectulin is also suitable for the
treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and
post-operative stabilisation in patients with diabetes mellitus.
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Clinical Use Issue id=Injectulin-d3e998 fullUrl=(none)
Type: indication
Details of indication: ketoacidosis (http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure) - Text: Injectulin is also suitable for the
treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and
post-operative stabilisation in patients with diabetes mellitus.
↸arrow indicates that this points back to the parent MedicinalProductDefinition rather then being linked forwards from it
Authorisation id=Injectulin-d3e142 fullUrl=(none)
Type: Marketing Authorisation [(220000000061)] (https://spor.ema.europa.eu/v1/lists/220000000060)
Identifier: EU/1/97/030/197 (http://ema.europa.eu/fhir/marketingAuthorisationNumber)
Date: from 2007-02-22
Status: Valid-VariedMarketingAuthorisation (http://ema.europa.eu/fhir/authorisationstatus)
Region: EU (http://ema.europa.eu/fhir/country)
Status date: 2007-02-21
Holder
Injectulin-holder (https://spor.ema.europa.eu/v1/locations)
Granted by:
Injectulin-regulator (https://spor.ema.europa.eu/v1/locations)
Date - exclusivityDate:
Date - dateOfFirstAuthorisation: 1996-02-21
Date - internationalBirthDate: 1996-02-22
Case
Identifier: EMEA/H/C/000901 (http://ema.europa.eu/fhir/procedureidentifier-number)
Type: EUauthorisationprocedures-CentralisedProcedure (http://ema.europa.eu/fhir/marketingAuthorisationProcedureType)
Date: from 1995-12-06 to 1996-03-29
Application IA38G (http://ema.europa.eu/fhir/applicationidentifier-number)
Type: TypeIAVariationNotification (http://ema.europa.eu/fhir/marketingAuthorisationApplicationType)
Date: 2016-11-29
Warning - Found 2 copies of RegulatedAuthorization HDHG469834(id=RA-HDHG469834-d3e501)(id=RA-HDHG469834-d3e512).
Warning - Found 2 copies of RegulatedAuthorization HDHG469834(id=RA-HDHG469834-d3e501)(id=RA-HDHG469834-d3e512).
Warning - Found 3 copies of RegulatedAuthorization HDGKD999999(id=RA-HDGKD999999-d3e553)(id=RA-HDGKD999999-d3e564)(id=RA-HDGKD999999-d3e575).
Warning - Found 3 copies of RegulatedAuthorization HDGKD999999(id=RA-HDGKD999999-d3e553)(id=RA-HDGKD999999-d3e564)(id=RA-HDGKD999999-d3e575).
Warning - Found 3 copies of RegulatedAuthorization HDGKD999999(id=RA-HDGKD999999-d3e553)(id=RA-HDGKD999999-d3e564)(id=RA-HDGKD999999-d3e575).