Path | Short | Definition | Comments |
---|---|---|---|
A pharmaceutical product described in terms of its composition and dose form | A pharmaceutical product described in terms of its composition and dose form. | ||
identifier | An identifier for the pharmaceutical medicinal product | An identifier for the pharmaceutical medicinal product. | |
administrableDoseForm | The administrable dose form, after necessary reconstitution | The administrable dose form, after necessary reconstitution. | |
unitOfPresentation | Todo | Todo. | |
ingredient | Ingredient | Ingredient. | |
device | Accompanying device | Accompanying device. | |
characteristics | Characteristics e.g. a products onset of action | Characteristics e.g. a products onset of action. | |
characteristics.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
characteristics.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
characteristics.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
characteristics.code | A coded characteristic | A coded characteristic. | |
characteristics.status | The status of characteristic e.g. assigned or pending | The status of characteristic e.g. assigned or pending. | |
routeOfAdministration | The path by which the pharmaceutical product is taken into or makes contact with the body | The path by which the pharmaceutical product is taken into or makes contact with the body. | |
routeOfAdministration.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
routeOfAdministration.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
routeOfAdministration.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
routeOfAdministration.code | Coded expression for the route | Coded expression for the route. | |
routeOfAdministration.firstDose | The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement | The first dose (dose quantity) administered in humans can be specified, for a product under investigation, using a numerical value and its unit of measurement. | |
routeOfAdministration.maxSingleDose | The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement | The maximum single dose that can be administered as per the protocol of a clinical trial can be specified using a numerical value and its unit of measurement. | |
routeOfAdministration.maxDosePerDay | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation. | |
routeOfAdministration.maxDosePerTreatmentPeriod | The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation | The maximum dose per treatment period that can be administered as per the protocol referenced in the clinical trial authorisation. | |
routeOfAdministration.maxTreatmentPeriod | The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation | The maximum treatment period during which an Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation. | |
routeOfAdministration.targetSpecies | A species for which this route applies | A species for which this route applies. | |
routeOfAdministration.targetSpecies.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
routeOfAdministration.targetSpecies.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
routeOfAdministration.targetSpecies.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
routeOfAdministration.targetSpecies.code | Coded expression for the species | Coded expression for the species. | |
routeOfAdministration.targetSpecies.withdrawalPeriod | A species specific time during which consumption of animal product is not appropriate | A species specific time during which consumption of animal product is not appropriate. | |
routeOfAdministration.targetSpecies.withdrawalPeriod.id | Unique id for inter-element referencing | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. | |
routeOfAdministration.targetSpecies.withdrawalPeriod.extension | Additional content defined by implementations | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
routeOfAdministration.targetSpecies.withdrawalPeriod.modifierExtension | Extensions that cannot be ignored even if unrecognized | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
routeOfAdministration.targetSpecies.withdrawalPeriod.tissue | Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk | Coded expression for the type of tissue for which the withdrawal period applues, e.g. meat, milk. | |
routeOfAdministration.targetSpecies.withdrawalPeriod.value | A value for the time | A value for the time. | |
routeOfAdministration.targetSpecies.withdrawalPeriod.supportingInformation | Extra information about the withdrawal period | Extra information about the withdrawal period. |
Qualitative and quantitative composition of a Medicinal Product in the dose form approved for administration in line with the regulated product information
Note that in many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.
identifier | An identifier for the pharmaceutical medicinal product | MedicinalProductPharmaceutical.identifier |
route | Coded expression for the route | MedicinalProductPharmaceutical.routeOfAdministration.code |
target-species | Coded expression for the species | MedicinalProductPharmaceutical.routeOfAdministration.targetSpecies.code |