Artifacts Summary

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health and changes regularly. See the Directory of published versions

Contents:

Behavior: Capability Statements
Behavior: Operation Definitions
Structures: Resource Profiles
Structures: Extension Definitions
Terminology: Value Sets
Terminology: Code Systems
Example: Example Instances
Other

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Behavior: Capability Statements

The following artifacts define the specific capabilities that different types of systems are expected to have in order to comply with this implementation guide. Systems conforming to this implementation guide are expected to declare conformance to one or more of the following capability statements.

capabilityStatement

This capability statement documents and outlines the FHIR interfaces exposed by the Gravitate Health FOSPS service. See more on https://www.gravitatehealth.eu/

Behavior: Operation Definitions

These are custom operations that can be supported by and/or invoked by systems conforming to this implementation guide.

annotate

This operation calculates an annotated version of an ePI as well as the separate extracts.

The ePI can be delivered either as a Bundle or by using an Identifier of the bundle. Whether the support of both Identifier and Bundle continues to be supported currently remains unknown.

diff

This operation calculates a diff between two FHIR resources - ie. a vanilla ePI FHIR bundle and a focused ePI FHIR bundle. The format follows the one defined at HAPI

focus

This operation calculates a focused version of an ePI as well as the separate extracts. The IPS can either be submitted as an IPS bundle or as an Identifer of the patient (using the ips-identifier parameter). If neither IPS Bundle or IPS identifier are passed as parameters it is expected that the Identifier of the patient is present as part of the security token. If the Identifier of the patient is submitted as an Identifier or as part of a security token it is up to the discression of the service implementing the focus-operation to fetch the IPS of the patient.

If the IPS is delivered as a bundle it must be encoded using Base64 as it is FHIR R4 compliant whereas the focus-operation is FHIR R5 compliant. The focus-operation will internally convert and extract the needed information from the R4 bundle.

The ePI can be delivered either as a Bundle or by using an Identifier of the bundle. Whether the support of both Identifier and Bundle continues to be supported currently remains unknown.

The persona dimension can be delivered either as a Bundle or by using an Identifier of the bundle. Whether the support of both Identifier and Bundle continues to be supported currently remains unknown.

Note: If the IPS is delivered as encoded Base64 content, there is a better opportunity for the submitting client to de-identify the Patient resource as the client can remove the Patient.identifier and mask out names and so on. While this may seem counter intuitive from an IPS point of view, the Patient identifiable components are not needed for the focusing mechanism to operate properly.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Additional Support Material Profile

Lens Profile

Persona Dimension - Digital Literacy

Persona Dimension - health Literacy

Persona Dimension Collection

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

HtmlElementLink

HtmlElementLinkV3

Lenses

Conveying Lens Information in the FHIR format

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

PDcategoryVS

PDtypeVS

ThreepointCategoryVS

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

Category of EPI

Example ICPC2 CS

Persona Vector Dimensions Code

Persona Vector Dimensions categories

Questionnaire example Dimensions

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

ACME industry as Marketing authorisation holder

Administrable product Aquilea Articulaciones Colageno y Magnesio 375gr

Administrable product BLASTON 1 mg tablets

Administrable product Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion

Administrable product Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes

Administrable product DOLOCATIL 1 g tablets

Administrable product Dovato 50 mg/300 mg film-coated tablets

Administrable product Enbrel 25 mg powder for solution for injection

Administrable product Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Administrable product Fluenz Tetra nasal spray suspension

Administrable product HIPÉRICO ARKOPHARMA cápsulas duras

Administrable product Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill

Administrable product Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass)

Administrable product Karvea 75 mg tablet

Administrable product Lipcut Simvastatin 5 mg Tablet

Administrable product MIRTAZAPINA CINFA 30 mg Coated Tablet

Administrable product Natures Plus Spiru-Tein

Administrable product Nurofen 100 mg Chewable Capsules

Administrable product Ogivri 150 mg powder for concentrate for solution for infusion

Administrable product Pentasa Slow Release Tablets 1g

Administrable product Remsima 100 mg powder for concentrate for solution for infusion

Administrable product SORIA NATURAL VITAMINA C 36 COMPRIMIDOS

Administrable product Skilarence 120 mg gastro-resistant tablets

Administrable product Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen

Administrable product Tegretol 200 mg tablets

Administrable product Xenical 120mg hard capsules

Arkopharma LABORATORIOS, S.A.U, as Marketing authorisation holder

AstraZeneca AB as Marketing authorisation holder

CHEPLAPHARM Arzneimittel GmbH as Marketing authorisation holder

Celltrion Healthcare Hungary Kft. as Marketing authorisation holder

Composition for Aquilea Articulaciones Colageno y Magnesio 375gr Package Leaflet

Composition for BLASTON 1 mg tablets Package Leaflet

Composition for Biktarvy 50 mg/200 mg/25 mg comprimidos revestidos por película Package Leaflet

Composition for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet

Composition for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion Package Leaflet

Composition for Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes Package Leaflet

Composition for DOLOCATIL 1 g tablets Package Leaflet

Composition for Dovato 50 mg/300 mg film-coated tablets Package Leaflet

Composition for Enbrel 25 mg powder for solution for injection Package Leaflet

Composition for Flucelvax Package Leaflet - preprocessed ES

Composition for Fluenz Tetra nasal spray suspension Package Leaflet

Composition for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet

Composition for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill Package Leaflet

Composition for Humalog Package Leaflet- Preprocessed

Composition for Humalog Package Leaflet - Preprocessed

Composition for Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) Package Leaflet

Composition for Karvea 75 mg tablet Package Leaflet

Composition for Karvea Package Leaflet PT Preprocessed

Composition for Lipcut Simvastatin 5 mg Tablet Package Leaflet

Composition for MIRTAZAPINA CINFA 30 mg Coated Tablet Package Leaflet

Composition for Natures Plus Spiru-Tein Package Leaflet

Composition for Nurofen 100 mg Chewable Capsules Package Leaflet

Composition for Ogivri 150 mg powder for concentrate for solution for infusion Package Leaflet

Composition for Pentasa Slow Release Tablets 1g Package Leaflet

Composition for Remsima 100 mg powder for concentrate for solution for infusion Package Leaflet

Composition for SORIA NATURAL VITAMINA C 36 COMPRIMIDOS Package Leaflet

Composition for Skilarence 120 mg gastro-resistant tablets Package Leaflet

Composition for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Package Leaflet

Composition for Tegretol 200 mg tablets Package Leaflet

Composition for Xenical 120mg hard capsules Package Leaflet

Eli Lilly Nederland B.V. as Marketing authorisation holder

Eli Lilly and Company as Manufacturer API

European Medicines Agency as Medicines Regulatory Authority

Example of additional support material - BUILTIN PDF

Example of additional support material - Structured Content

Example of additional support material - URL

FERRER INTERNACIONAL, S.A. as Marketing authorisation holder

FERRING S.A.U. as Marketing authorisation holder

GLAXO WELLCOME, S.A. as Manufacturer

Gilead Sciences Ireland UC as Marketing authorisation holder

Ingredient-active A/Darwin/9/2021 (H3N2)

A/Darwin/9/2021 (H3N2)

Ingredient-active A/Victoria/4897/2022

A/Victoria/4897/2022

Ingredient-active ASCORBIC ACID

ASCORBIC ACID

Ingredient-active B/Austria/1359417/2021

B/Austria/1359417/2021

Ingredient-active B/Phuket/3073/2013 -

B/Phuket/3073/2013 -

Ingredient-active BICTEGRAVIR SODIUM

BICTEGRAVIR SODIUM

Ingredient-active CARBAMAZEPINE

CARBAMAZEPINE

Ingredient-active CINITAPRIDE

CINITAPRIDE

Ingredient-active Calcium Carbonate

Calcium Carbonate

Ingredient-active DIMETHYL FUMARATE

DIMETHYL FUMARATE

Ingredient-active DOLUTEGRAVIR SODIUM

DOLUTEGRAVIR SODIUM

Ingredient-active Emtricitabine

Emtricitabine

Ingredient-active Etanercept

Etanercept

Ingredient-active HUMAN TYPE I COLLAGEN

HUMAN TYPE I COLLAGEN

Ingredient-active Hypericum perforatum L.

Hypericum perforatum L.

Ingredient-active IBUPROFEN

IBUPROFEN

Ingredient-active INFLIXIMAB

INFLIXIMAB

Ingredient-active INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE

INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE

Ingredient-active INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE

INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE

Ingredient-active INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE

INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE

Ingredient-active INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE

INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE

Ingredient-active Insulin Lispro

Insulin Lispro

Ingredient-active Insulin glargine

Insulin glargine

Ingredient-active Lixisenatide

Lixisenatide

Ingredient-active Mirtazapine

Mirtazapine

Ingredient-active ORLISTAT

ORLISTAT

Ingredient-active SIMVASTATIN

SIMVASTATIN

Ingredient-active SOY PROTEIN

SOY PROTEIN

Ingredient-active Sodium

Sodium

Ingredient-active adalimumab

adalimumab

Ingredient-active cholecalciferol

cholecalciferol

Ingredient-active hydrogenated soybean oil

hydrogenated soybean oil

Ingredient-active irbesartan

irbesartan

Ingredient-active lactose monohydrate

lactose monohydrate

Ingredient-active lamivudine

lamivudine

Ingredient-active magnesium

magnesium

Ingredient-active mesalazine

mesalazine

Ingredient-active paracetamol

paracetamol

Ingredient-active sucrose

sucrose

Ingredient-active tenofovir alafenamide

tenofovir alafenamide

Ingredient-active trastuzumab

trastuzumab

Ingredient-excipient ANHYDROUS DEXTROSE

ANHYDROUS DEXTROSE

Ingredient-excipient Anhydrous citric acid

Anhydrous citric acid

Ingredient-excipient Arginine hydrochloride

Arginine hydrochloride

Ingredient-excipient CARBOXYMETHYLCELLULOSE

CARBOXYMETHYLCELLULOSE

Ingredient-excipient CITRIC ACID MONOHYDRATE

CITRIC ACID MONOHYDRATE

Ingredient-excipient CORN STARCH

CORN STARCH

Ingredient-excipient Carnauba wax

Carnauba wax

Ingredient-excipient Croscarmellose sodium

Croscarmellose sodium

Ingredient-excipient Croscarmellose sodium

Croscarmellose sodium

Ingredient-excipient Dipotassium phosphate

Dipotassium phosphate

Ingredient-excipient Disodium phosphate dihydrate

Disodium phosphate dihydrate

Ingredient-excipient Ethylcellulose

Ethylcellulose

Ingredient-excipient GELATIN, UNSPECIFIED

GELATIN, UNSPECIFIED

Ingredient-excipient GLYCEROL 85% [WHO-DD]

GLYCEROL 85% [WHO-DD]

Ingredient-excipient Gelatin (porcine, Type A)

Gelatin (porcine, Type A)

Ingredient-excipient Glycerol

Glycerol

Ingredient-excipient HYDROCHLORIC ACID [IARC]

HYDROCHLORIC ACID [IARC]

Ingredient-excipient HYDROXYPROPYL CELLULOSE, UNSPECIFIED

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Ingredient-excipient HYPROMELLOSE, UNSPECIFIED

HYPROMELLOSE, UNSPECIFIED

Ingredient-excipient Hydrochloric acid

Hydrochloric acid

Ingredient-excipient Hypromellose

Hypromellose

Ingredient-excipient LACTOSE MONOHYDRATE

LACTOSE MONOHYDRATE

Ingredient-excipient LECITHIN, SOYBEAN

LECITHIN, SOYBEAN

Ingredient-excipient Lactose Monohydrate

Lactose Monohydrate

Ingredient-excipient MAGNESIUM CHLORIDE

MAGNESIUM CHLORIDE

Ingredient-excipient MANNITOL

MANNITOL

Ingredient-excipient MICROCRYSTALLINE CELLULOSE

MICROCRYSTALLINE CELLULOSE

Ingredient-excipient Macrogol 3000

Macrogol 3000

Ingredient-excipient Magnesium stearate

Magnesium stearate

Ingredient-excipient Magnesium stearate

Magnesium stearate

Ingredient-excipient Magnesium stearate

Magnesium stearate

Ingredient-excipient Magnesium stearate

Magnesium stearate

Ingredient-excipient Magnesium stearate

Magnesium stearate

Ingredient-excipient Magnesium stearate

Magnesium stearate

Ingredient-excipient Magnesium stearate

Magnesium stearate

Ingredient-excipient Mannitol

Mannitol

Ingredient-excipient Metacresol

Metacresol

Ingredient-excipient Metacresol

Metacresol

Ingredient-excipient Methionine

Methionine

Ingredient-excipient Microcrystalline cellulose

Microcrystalline cellulose

Ingredient-excipient Microcrystalline cellulose

Microcrystalline cellulose

Ingredient-excipient Microcrystalline cellulose

Microcrystalline cellulose

Ingredient-excipient Monosodium glutamate monohydrate

Monosodium glutamate monohydrate

Ingredient-excipient POLYSORBATE 80

POLYSORBATE 80

Ingredient-excipient POVIDONE, UNSPECIFIED

POVIDONE, UNSPECIFIED

Ingredient-excipient POVIDONE, UNSPECIFIED

POVIDONE, UNSPECIFIED

Ingredient-excipient POVIDONE, UNSPECIFIED

POVIDONE, UNSPECIFIED

Ingredient-excipient Polysorbate 80

Polysorbate 80

Ingredient-excipient Potassium chloride

Potassium chloride

Ingredient-excipient Potassium dihydrogen phosphate

Potassium dihydrogen phosphate

Ingredient-excipient Potassium dihydrogen phosphate

Potassium dihydrogen phosphate

Ingredient-excipient Povidone

Povidone

Ingredient-excipient SILICA, COLLOIDAL ANHYDROUS

SILICA, COLLOIDAL ANHYDROUS

Ingredient-excipient SILICA, COLLOIDAL ANHYDROUS

SILICA, COLLOIDAL ANHYDROUS

Ingredient-excipient SILICA, COLLOIDAL ANHYDROUS

SILICA, COLLOIDAL ANHYDROUS

Ingredient-excipient SODIUM CITRATE, UNSPECIFIED FORM

SODIUM CITRATE, UNSPECIFIED FORM

Ingredient-excipient SODIUM LAURYL SULFATE

SODIUM LAURYL SULFATE

Ingredient-excipient SODIUM PHOSPHATE, DIBASIC, DIHYDRATE

SODIUM PHOSPHATE, DIBASIC, DIHYDRATE

Ingredient-excipient SODIUM PHOSPHATE, DIBASIC, DIHYDRATE

SODIUM PHOSPHATE, DIBASIC, DIHYDRATE

Ingredient-excipient SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE

SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE

Ingredient-excipient SODIUM STARCH GLYCOLATE TYPE A

SODIUM STARCH GLYCOLATE TYPE A

Ingredient-excipient SORBITOL

SORBITOL

Ingredient-excipient STARCH, CORN

STARCH, CORN

Ingredient-excipient STARCH, CORN

STARCH, CORN

Ingredient-excipient STARCH, POTATO

STARCH, POTATO

Ingredient-excipient STARCH, POTATO

STARCH, POTATO

Ingredient-excipient STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION

Ingredient-excipient STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION

Ingredient-excipient STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION

Ingredient-excipient SUCROSE

SUCROSE

Ingredient-excipient Silicon dioxide

Silicon dioxide

Ingredient-excipient Sodium Hydroxide

Sodium Hydroxide

Ingredient-excipient Sodium chloride

Sodium chloride

Ingredient-excipient Sodium chloride

Sodium chloride

Ingredient-excipient Sodium dihydrogen phosphate monohydrate

Sodium dihydrogen phosphate monohydrate

Ingredient-excipient Sodium hydroxide

Sodium hydroxide

Ingredient-excipient Sucrose

Sucrose

Ingredient-excipient Sucrose

Sucrose

Ingredient-excipient Sucrose

Sucrose

Ingredient-excipient TITANIUM DIOXIDE

TITANIUM DIOXIDE

Ingredient-excipient TITANIUM DIOXIDE

TITANIUM DIOXIDE

Ingredient-excipient TROMETHAMINE

TROMETHAMINE

Ingredient-excipient Talc

Talc

Ingredient-excipient Titanium Dioxide

Titanium Dioxide

Ingredient-excipient Trometamol

Trometamol

Ingredient-excipient Water for injections

Water for injections

Ingredient-excipient Water for injections

Water for injections

Ingredient-excipient Zinc Oxide

Zinc Oxide

Ingredient-excipient Zinc chloride

Zinc chloride

Ingredient-excipient acmedrug-ing2

acmedrug-ing2

Ingredient-excipient acmedrug-ing3

acmedrug-ing3

Ingredient-excipient colloidal hydrophobic silica

colloidal hydrophobic silica

Ingredient-excipient macrogol 6000

macrogol 6000

Ingredient-excipient magnesium stearate

magnesium stearate

Ingredient-excipient magnesium stearate

magnesium stearate

Ingredient-excipient maltodextrin

maltodextrin

Ingredient-excipient mannitol

mannitol

Ingredient-excipient microcrystalline cellulose

microcrystalline cellulose

Ingredient-excipient microcrystalline cellulose

microcrystalline cellulose

Ingredient-excipient povidone

povidone

Ingredient-excipient saccharin sodium

saccharin sodium

Ingredient-excipient sodium bicarbonate

sodium bicarbonate

Ingredient-excipient sodium cyclamate

sodium cyclamate

Ingredient-excipient sodium starch glycolate

sodium starch glycolate

LABORATORIOS CINFA, S.A. as Marketing authorisation holder

Laboratorios Farmacéuticos ROVI, S.A. as Marketing authorisation holder

Lacer, S.A. - Boters, 5 as Marketing authorisation holder

Lilly S.A. as Manufacturer

List of Biktarvy Package Leaflets

List of Dovato Package Leaflets

List of biktarvy Package Leaflets

List of dovato Package Leaflets

List of enbrel smpc Package Leaflets

List of flucelvax Package Leaflets

List of karvea Package Leaflets

List of xenical Package Leaflets

Manufactured item Aquilea Articulaciones Colageno y Magnesio 375gr

Manufactured item BLASTON 1 mg tablets

Manufactured item Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion

Manufactured item Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes

Manufactured item DOLOCATIL 1 g tablets

Manufactured item Dovato 50 mg/300 mg film-coated tablets

Manufactured item Enbrel 25 mg powder for solution for injection

Manufactured item Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Manufactured item Fluenz Tetra nasal spray suspension

Manufactured item HIPÉRICO ARKOPHARMA cápsulas duras

Manufactured item Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill

Manufactured item Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass)

Manufactured item Karvea 75 mg tablet

Manufactured item Lipcut Simvastatin 5 mg Tablet

Manufactured item MIRTAZAPINA CINFA 30 mg Coated Tablet

Manufactured item Natures Plus Spiru-Tein

Manufactured item Nurofen 100 mg Chewable Capsules

Manufactured item Ogivri 150 mg powder for concentrate for solution for infusion

Manufactured item Pentasa Slow Release Tablets 1g

Manufactured item Remsima 100 mg powder for concentrate for solution for infusion

Manufactured item SORIA NATURAL VITAMINA C 36 COMPRIMIDOS

Manufactured item Skilarence 120 mg gastro-resistant tablets

Manufactured item Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen

Manufactured item Tegretol 200 mg tablets

Manufactured item Xenical 120mg hard capsules

MedImmune, UK Limited as Manufacturer

Medicinal Product Aquilea Articulaciones Colageno y Magnesio 375gr

Aquilea Articulaciones Colageno y Magnesio 375gr

Medicinal Product BLASTON 1 mg tablets

BLASTON 1 mg tablets

Medicinal Product Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion

Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion

Medicinal Product Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes

Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes

Medicinal Product DOLOCATIL 1 g tablets

DOLOCATIL 1 g tablets

Medicinal Product Dovato 50 mg/300 mg film-coated tablets

Dovato 50 mg/300 mg film-coated tablets

Medicinal Product Enbrel 25 mg powder for solution for injection

Enbrel 25 mg powder for solution for injection

Medicinal Product Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Medicinal Product Fluenz Tetra nasal spray suspension

Fluenz Tetra nasal spray suspension

Medicinal Product HIPÉRICO ARKOPHARMA cápsulas duras

HIPÉRICO ARKOPHARMA cápsulas duras

Medicinal Product Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill

Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill

Medicinal Product Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass)

Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass)

Medicinal Product Karvea 75 mg tablet

Karvea 75 mg tablet

Medicinal Product Lipcut Simvastatin 5 mg Tablet

Lipcut Simvastatin 5 mg Tablet

Medicinal Product MIRTAZAPINA CINFA 30 mg Coated Tablet

MIRTAZAPINA CINFA 30 mg Coated Tablet

Medicinal Product Natures Plus Spiru-Tein

Natures Plus Spiru-Tein

Medicinal Product Nurofen 100 mg Chewable Capsules

Nurofen 100 mg Chewable Capsules

Medicinal Product Ogivri 150 mg powder for concentrate for solution for infusion

Ogivri 150 mg powder for concentrate for solution for infusion

Medicinal Product Pentasa Slow Release Tablets 1g

Pentasa Slow Release Tablets 1g

Medicinal Product Remsima 100 mg powder for concentrate for solution for infusion

Remsima 100 mg powder for concentrate for solution for infusion

Medicinal Product SORIA NATURAL VITAMINA C 36 COMPRIMIDOS

SORIA NATURAL VITAMINA C 36 COMPRIMIDOS

Medicinal Product Skilarence 120 mg gastro-resistant tablets

Skilarence 120 mg gastro-resistant tablets

Medicinal Product Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen

Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen

Medicinal Product Tegretol 200 mg tablets

Tegretol 200 mg tablets

Medicinal Product Xenical 120mg hard capsules

Xenical 120mg hard capsules

Medicinal Product cava 75 mg tablet in blister pack of 28 tablets

EU/1/97/049/001 cava 75 mg tablet blister x28

Novartis Farmacéutica, S.A. as Marketing authorisation holder

Packaged Product Definition: Aquilea Articulaciones Colageno y Magnesio 375gr 28

Packaged Product Definition: BLASTON 1 mg tablets 50

Packaged Product Definition: Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 30

Packaged Product Definition: Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 90

Packaged Product Definition: Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes 30

Packaged Product Definition: DOLOCATIL 1 g tablets 20

Packaged Product Definition: Dovato 50 mg/300 mg film-coated tablets 30

Packaged Product Definition: Enbrel 25 mg powder for solution for injection 28

Packaged Product Definition: Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 1

Packaged Product Definition: Fluenz Tetra nasal spray suspension 1

Packaged Product Definition: Fluenz Tetra nasal spray suspension 10

Packaged Product Definition: HIPÉRICO ARKOPHARMA cápsulas duras 30

Packaged Product Definition: Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill 5

Packaged Product Definition: Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) 2

Packaged Product Definition: Karvea 75 mg tablet 14

Packaged Product Definition: Karvea 75 mg tablet 28

Packaged Product Definition: Karvea 75 mg tablet 56

Packaged Product Definition: Karvea 75 mg tablet 98

Packaged Product Definition: Lipcut Simvastatin 5 mg Tablet 28

Packaged Product Definition: MIRTAZAPINA CINFA 30 mg Coated Tablet 30

Packaged Product Definition: Natures Plus Spiru-Tein nan

Packaged Product Definition: Nurofen 100 mg Chewable Capsules 2

Packaged Product Definition: Ogivri 150 mg powder for concentrate for solution for infusion 1

Packaged Product Definition: Pentasa Slow Release Tablets 1g 28

Packaged Product Definition: Remsima 100 mg powder for concentrate for solution for infusion 1

Packaged Product Definition: SORIA NATURAL VITAMINA C 36 COMPRIMIDOS 36

Packaged Product Definition: Skilarence 120 mg gastro-resistant tablets 40

Packaged Product Definition: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 10

Packaged Product Definition: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 3

Packaged Product Definition: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 5

Packaged Product Definition: Tegretol 200 mg tablets 28

Packaged Product Definition: Xenical 120mg hard capsules 1

Pedro Persona Vector - Collection

Persona Dimension - Collection

Persona Dimension - Employment

Persona Dimension - Extrovert/introvert

Persona Dimension - Share info Willingly

Persona Dimension - WorkLife

Pfizer Europe MA EEIG as Marketing authorisation holder

Questionnaire-example

Questionnaire Example

QuestionnaireResponse-example

Questionnaire Response example

Reckitt Benckiser Healthcare, Lda. as Marketing authorisation holder

Regulated Authorization for Aquilea Articulaciones Colageno y Magnesio 375gr 0

Regulated Authorization for BLASTON 1 mg tablets 0

Regulated Authorization for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion 0

Regulated Authorization for Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes 0

Regulated Authorization for DOLOCATIL 1 g tablets 0

Regulated Authorization for Dovato 50 mg/300 mg film-coated tablets 0

Regulated Authorization for Enbrel 25 mg powder for solution for injection 0

Regulated Authorization for Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 0

Regulated Authorization for Fluenz Tetra nasal spray suspension 0

Regulated Authorization for Fluenz Tetra nasal spray suspension 1

Regulated Authorization for HIPÉRICO ARKOPHARMA cápsulas duras 0

Regulated Authorization for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill 0

Regulated Authorization for Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) 0

Regulated Authorization for Karvea 75 mg tablet 0

Regulated Authorization for Karvea 75 mg tablet 1

Regulated Authorization for Karvea 75 mg tablet 2

Regulated Authorization for Karvea 75 mg tablet 3

Regulated Authorization for Lipcut Simvastatin 5 mg Tablet 0

Regulated Authorization for MIRTAZAPINA CINFA 30 mg Coated Tablet 0

Regulated Authorization for Natures Plus Spiru-Tein 0

Regulated Authorization for Nurofen 100 mg Chewable Capsules 0

Regulated Authorization for Ogivri 150 mg powder for concentrate for solution for infusion 0

Regulated Authorization for Pentasa Slow Release Tablets 1g 0

Regulated Authorization for Remsima 100 mg powder for concentrate for solution for infusion 0

Regulated Authorization for SORIA NATURAL VITAMINA C 36 COMPRIMIDOS 0

Regulated Authorization for Skilarence 120 mg gastro-resistant tablets 0

Regulated Authorization for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 0

Regulated Authorization for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 1

Regulated Authorization for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen 2

Regulated Authorization for Tegretol 200 mg tablets 0

Regulated Authorization for Xenical 120mg hard capsules 0

Sandoz A/S as Marketing authorisation holder

Sanofi Winthrop Industrie as Marketing authorisation holder

Sanofi Winthrop Industrie as Manufacturer

Sanofi-Aventis Deutschland GmbH as Manufacturer

Sanofi-Aventis Groupe as Marketing authorisation holder

Seqirus Netherlands B.V. as Marketing authorisation holder

Viatris Limited as Marketing authorisation holder

ViiV Healthcare BV as Marketing authorisation holder

[Preprocessed] ePI document Bundle for Karvea 75 mg Package Leaflet

[Preprocessed] Bundle for Karvea 75 mg Package Leaflet ePI document

[Preprocessed] ePI document for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet

[Preprocessed] Bundle for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet ePI document

[Preprocessed] ePI document for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet

[Preprocessed] Bundle for CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES Package Leaflet ePI document

[Preprocessed] ePI document for Dovato 50 mg/300 mg comprimidos Package Leaflet

[Preprocessed] Bundle for Dovato 50 mg/300 mg comprimidos Package Leaflet ePI document

[Preprocessed] ePI document for Flucelvax Package Leaflet in ES

[Preprocessed] Bundle for Flucelvax Package Leaflet ePI document in ES

[Preprocessed] ePI document for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet

[Preprocessed] Bundle for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet ePI document

[Processed] ePI document Bundle for biktarvy-es Package Leaflet for language es

[Processed] Bundle for biktarvy-es Package Leaflet ePI document

[Processed] ePI document Bundle for biktarvy-pt Package Leaflet for language pt

[Processed] Bundle for biktarvy-pt Package Leaflet ePI document

contraindication

Contraindication - Gastrointestinal disorders

cud-42659cd40ce761bcf6d15bd28423e45f

indication - Hypertension

cud-4fce9d5258f70f7d605059f97c24efa8

interaction - METHOTREXATE

cud-585e364c14debe29f6c6b564138aa400

indication - Hypertension

cud-7b1263be67675b61a6b6e6f0a5c35389

interaction - Bezafibrat

cud-a40c2367ed3c1c715eacd432105752a0

contraindication - Diabetis Mellitus

cud-d79af6e660f456c6c7091803d6bd1a92

contraindication - nan

ePI document Bundle for Aquilea Articulaciones Colageno y Magnesio 375gr Package Leaflet for language es

ePI document Bundle for BLASTON 1 mg tablets Package Leaflet for language es

ePI document Bundle for Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion Package Leaflet for language es

ePI document Bundle for Calcio/Vitamina D3 ROVI 1000 mg/880 UI comprimidos efervescentes Package Leaflet for language es

ePI document Bundle for DOLOCATIL 1 g tablets Package Leaflet for language en

ePI document Bundle for Dovato 50 mg/300 mg film-coated tablets Package Leaflet for language es

ePI document Bundle for Enbrel 25 mg powder for solution for injection Package Leaflet for language en

ePI document Bundle for Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) Package Leaflet for language es

ePI document Bundle for Fluenz Tetra nasal spray suspension Package Leaflet for language en

ePI document Bundle for HIPÉRICO ARKOPHARMA cápsulas duras Package Leaflet for language es

ePI document Bundle for Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill Package Leaflet for language en

ePI document Bundle for Humira 40 mg Solution for injection Subcutaneous use pre-filled syringe (glass) Package Leaflet for language en

ePI document Bundle for Karvea 75 mg Package Leaflet for language pt

Bundle for Karvea 75 mg Package Leaflet ePI document

ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language en

ePI document Bundle for Karvea 75 mg tablet Package Leaflet for language es

ePI document Bundle for Lipcut Simvastatin 5 mg Tablet Package Leaflet for language en

ePI document Bundle for MIRTAZAPINA CINFA 30 mg Coated Tablet Package Leaflet for language es

ePI document Bundle for Natures Plus Spiru-Tein Package Leaflet for language es

ePI document Bundle for Nurofen 100 mg Chewable Capsules Package Leaflet for language en

ePI document Bundle for Ogivri 150 mg powder for concentrate for solution for infusion Package Leaflet for language en

ePI document Bundle for Pentasa Slow Release Tablets 1g Package Leaflet for language en

ePI document Bundle for Remsima 100 mg powder for concentrate for solution for infusion Package Leaflet for language en

ePI document Bundle for SORIA NATURAL VITAMINA C 36 COMPRIMIDOS Package Leaflet for language es

ePI document Bundle for Skilarence 120 mg gastro-resistant tablets Package Leaflet for language en

ePI document Bundle for Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Package Leaflet for language en

ePI document Bundle for Tegretol 200 mg tablets Package Leaflet for language es

ePI document Bundle for Xenical 120mg hard capsules Package Leaflet for language es

substance-adalimumab

ADALIMUMAB

substance-ascorbicacid

ASCORBIC ACID

substance-calciumcarbonate

Calcium Carbonate

substance-carbamazepine

CARBAMAZEPINE

substance-cinitapride

CINITAPRIDE

substance-dimethylfumarate

DIMETHYL FUMARATE

substance-dolutegravirsodium

DOLUTEGRAVIR SODIUM

substance-etanercept

Etanercept

substance-hypericumperforatumwhole

HYPERICUM PERFORATUM WHOLE

substance-ibuprofen

IBUPROFEN

substance-infliximab

INFLIXIMAB

substance-influenzaavirusadarwin112021h3n2whole

INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE

substance-influenzaavirusadelaware552019cvr45h1n1whole

INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE

substance-influenzabvirusbsingaporeinftt1606102016whole

INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE

substance-influenzabvirusbsingaporewuh46182021whole

INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE

substance-insulinglargine

Insulin glargine

substance-insulinlispro

INSULIN LISPRO

substance-irbesartan

irbesartan

substance-lamivudine

lamivudine

substance-lixisenatide

Lixisenatide

substance-magnesium

magnesium

substance-mesalamine

MESALAMINE

substance-mirtazapine

Mirtazapine

substance-orlistat

ORLISTAT

substance-paracetamol

paracetamol

substance-simvastatin

SIMVASTATIN

substance-soyprotein

SOY PROTEIN

substance-trastuzumab

trastuzumab

Other

These are resources that are used within this implementation guide that do not fit into one of the other categories.

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Aclasta Sandoz (Bundle)

Actrapid Penfill Novo Nordisk (Bundle)

AeroBec Autohaler Teva (Bundle)

AeroBec Teva (Bundle)

Airomir Autohaler Teva (Bundle)

Alendronat Mylan tabletter 70 mg (Bundle)

Apidra sanofi-aventis ferdigfylt penn, SoloStar (Bundle)

Aprovel Sanofi tabletter 150 mg (Bundle)

Aprovel Sanofi tabletter 300 mg (Bundle)

Asacol Tillotts Pharma enterotabletter (Bundle)

GALVUS tabletti 50 mg (Bundle)

Humira 40mg/0,4 ml injektionsvæske, opl. i sprøjte (Bundle)

Hyrimoz 40 mg injektionsvæske, opl. i pen (Bundle)

Hyrimoz 40 mg injektionsvæske, opl. i sprøjte (Bundle)

Ibrance (palbociclib) tablets - THIS DOCUMENT IS FOR TESTING PURPOSES ONLY. (Bundle)

Imurel® 25 mg og 50 mg filmovertrukne tabletter (Bundle)

JANUMET tabletti, kalvopäällysteinen 50/850 mg, 50/1000 mg (Bundle)

JANUVIA tabletti, kalvopäällysteinen 25 mg, 50 mg, 100 mg (Bundle)

PENTASA depottabletti 1 g (Bundle)

PENTASA depottabletti 500 mg (Bundle)

Prednisolon "Unimedic" 31,25 mg rektalvæske, opløsning (Bundle)

REMICADE kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos 100 mg (Bundle)

STELARA injektioneste, liuos, esitäytetty ruisku 45 mg (Bundle)

STELARA injektioneste, liuos, esitäytetty ruisku 90 mg (Bundle)

VENTOLINE DISKUS inhalaatiojauhe, annosteltu 200 mikrog/annos (Bundle)

VENTOLINE sumutinliuos 5 mg/ml (Bundle)