Name Flags Card. Type Description & Constraints doco
. . MedicinalProduct Σ TU DomainResource Detailed 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 Σ 0..* Identifier Business identifier for this product. Could be an MPID
. . . type Σ 0..1 CodeableConcept Regulatory type, e.g. Investigational or Authorized
. . . domain Σ 0..1 Coding If this medicine applies to human or veterinary uses
. . . combinedPharmaceuticalDoseForm Σ 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product
. . . legalStatusOfSupply Σ 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator
. . . additionalMonitoringIndicator Σ 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
. . . specialMeasures Σ 0..* string Whether the Medicinal Product is subject to special measures for regulatory reasons
. . . paediatricUseIndicator Σ 0..1 CodeableConcept If authorised for use in children
. . . productClassification Σ 0..* CodeableConcept Allows the product to be classified by various systems
. . . marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorizaton
. . . pharmaceuticalProduct Σ 0..* Reference( MedicinalProductPharmaceutical) Pharmaceutical aspects of product
. . . packagedMedicinalProduct Σ 0..* Reference( MedicinalProductPackaged) Package representation for the product
. . . attachedDocument Σ 0..* Reference( DocumentReference) Supporting documentation, typically for regulatory submission
. . . masterFile Σ 0..* Reference( DocumentReference) A master file for to the medicinal product (e.g. Pharmacovigilance System Master File)
. . . contact Σ 0..* Reference( Organization | PractitionerRole) A product specific contact, person (in a role), or an organization
. . . clinicalTrial Σ 0..* Reference( ResearchStudy) Clinical trials or studies that this product is involved in
. . . name Σ 1..* BackboneElement The product's name, including full name and possibly coded parts
. . . . productName Σ 1..1 string The full product name
. . . . namePart Σ 0..* BackboneElement Coding words or phrases of the name
. . . . . part Σ 1..1 string A fragment of a product name
. . . . . type Σ 1..1 Coding Idenifying type for this part of the name (e.g. strength part)
. . . . countryLanguage Σ 0..* BackboneElement Country where the name applies
. . . . . country Σ 1..1 CodeableConcept Country code for where this name applies
. . . . . jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
. . . . . language Σ 1..1 CodeableConcept Language code for this name
. . . crossReference Σ 0..* Identifier Reference to another product, e.g. for linking authorised to investigational product
. . . manufacturingBusinessOperation Σ 0..* BackboneElement An operation applied to the product, for manufacturing or adminsitrative purpose
. . . . operationType Σ 0..1 CodeableConcept The type of manufacturing operation
. . . . authorisationReferenceNumber Σ 0..1 Identifier Regulatory authorization reference number
. . . . effectiveDate Σ 0..1 dateTime Regulatory authorization date
. . . . confidentialityIndicator Σ 0..1 CodeableConcept To indicate if this proces is commercially confidential
. . . . manufacturer Σ 0..* Reference( Organization) The manufacturer or establishment associated with the process
. . . . regulator Σ 0..1 Reference( Organization) A regulator which oversees the operation
. . . specialDesignation Σ 0..* BackboneElement Indicates if the medicinal product has an orphan designation for the treatment of a rare disease
. . . . identifier Σ 0..* Identifier Identifier for the designation, or procedure number
. . . . type Σ 0..1 CodeableConcept The type of special designation, e.g. orphan drug, minor use
. . . . intendedUse Σ 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment
. . . . indication[x] Σ 0..1 Condition for which the medicinal use applies
. . . . . indicationCodeableConcept CodeableConcept
. . . . . indicationReference Reference( MedicinalProductIndication)
. . . . status Σ 0..1 CodeableConcept For example granted, pending, expired or withdrawn
. . . . date Σ 0..1 dateTime Date when the designation was granted
. . . . species Σ 0..1 CodeableConcept Animal species for which this applies

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