NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProduct ΣTUDomainResourceDetailed definition of a medicinal product, typically for uses other than direct patient care (e.g. regulatory use)
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness idenfifier for this product. Could be an MPID
... type Σ0..1CodeableConceptRegulatory type, e.g. Investigational or Authorized
... domain Σ0..1CodingIf this medicine applies to human or veterinary uses
... combinedPharmaceuticalDoseForm Σ0..1CodeableConceptThe dose form for a single part product, or combined form of a multiple part product
... additionalMonitoringIndicator Σ0..1CodeableConceptWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
... specialMeasures Σ0..*stringWhether the Medicinal Product is subject to special measures for regulatory reasons
... paediatricUseIndicator Σ0..1CodeableConceptIf authorised for use in children
... productClassification Σ0..*CodeableConceptAllows the product to be classified by various systems
... marketingStatus Σ0..*MarketingStatusMarketing status of the medicinal product, in contrast to marketing authorizaton
... marketingAuthorization Σ0..1Reference(MedicinalProductAuthorization)Product regulatory authorization
... packagedMedicinalProduct Σ0..*Reference(MedicinalProductPackaged)Package representation for the product
... pharmaceuticalProduct Σ0..*Reference(MedicinalProductPharmaceutical)Pharmaceutical aspects of product
... contraindication Σ0..*Reference(MedicinalProductContraindication)Clinical contraindications, reasons for not giving this
... interaction Σ0..*Reference(MedicinalProductInteraction)Clinical interactions with other medications or substances
... therapeuticIndication Σ0..*Reference(MedicinalProductIndication)Clinical reason for use
... undesirableEffect Σ0..*Reference(MedicinalProductUndesirableEffect)Potential clinical unwanted effects of use
... attachedDocument Σ0..*Reference(DocumentReference)Supporting documentation, typically for regulatory submission
... masterFile Σ0..*Reference(DocumentReference)A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ0..*Reference(Organization | PractitionerRole)A product specific contact, person (in a role), or an organization
... clinicalTrial Σ0..*Reference(ResearchStudy)Clinical trials or studies that this product is involved in
... name Σ1..*BackboneElementThe product's name, including full name and possibly coded parts
.... productName Σ1..1stringThe full product name
.... namePart Σ0..*BackboneElementCoding words or phrases of the name
..... part Σ1..1stringA fragment of a product name
..... type Σ1..1CodingIdenifying type for this part of the name (e.g. strength part)
.... countryLanguage Σ0..*BackboneElementCountry where the name applies
..... country Σ1..1CodeableConceptCountry code for where this name applies
..... jurisdiction Σ0..1CodeableConceptJurisdiction code for where this name applies
..... language Σ1..1CodeableConceptLanguage code for this name
... crossReference Σ0..*IdentifierReference to another product, e.g. for linking authorised to investigational product
... manufacturingBusinessOperation Σ0..*BackboneElementAn operation applied to the product, for manufacturing or adminsitrative purpose
.... operationType Σ0..1CodeableConceptThe type of manufacturing operation
.... authorisationReferenceNumber Σ0..1IdentifierRegulatory authorization reference number
.... effectiveDate Σ0..1dateTimeRegulatory authorization date
.... confidentialityIndicator Σ0..1CodeableConceptTo indicate if this proces is commercially confidential
.... manufacturer Σ0..*Reference(Organization)The manufacturer or establishment associated with the process
.... regulator Σ0..1Reference(Organization)A regulator which oversees the operation
... specialDesignation Σ0..*BackboneElementIndicates if the medicinal product has an orphan designation for the treatment of a rare disease
.... identifier Σ0..*IdentifierIdentifier for the designation, or procedure number
.... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
.... indication Σ0..1CodeableConceptCondition for which the medicinal use applies
.... status Σ0..1CodeableConceptFor example granted, pending, expired or withdrawn
.... date Σ0..1dateTimeDate when the designation was granted
.... species Σ0..1CodeableConceptAnimal species for which this applies

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