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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).