IDMP-O Example Qlaira from EMA PMS Implementation Guide, Chapter 8
This ontology provides an example EMA from the Implementation Guide, Chapter 8 using the IDMP Ontology v1.0.
Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
Concepts or properties starting with the https://spec.pistoiaalliance.org/idmp/ontology/ISO/ExtensionTBD/... do indicate that this requires extension to the current IDMP-O version.
Copyright (c) 2022-2024 EDM Council, Inc.
Copyright (c) 2022-2024 Pistoia Alliance, Inc.
This example is for illustration purposes only. The data provided may not be up-to-date, and in some cases, 'dummy' data has been included. The product information included here shall not be used for any other purpose than for educational purposes regarding the IDMP-O implementation.
EMA medicinal product identifier - IE-100000833-00000003
EMA medicinal product identifier - IE-100000833-00000003-0001
EMA medicinal product identifier - IE-100000833-00000003-0002
EMA medicinal product identifier - IE-100000833-00000003-0003
Qlaira, packaged medicinal product, 1 x 28 box, SKU
Qlaira, packaged medicinal product, 3 x 28 box, SKU
Qlaira, packaged medicinal product, 6 x 28 box, SKU
Qlaira, dark red tablets, active ingredient, estradiol valerate
Qlaira, dark red tablets, active ingredient, estradiol valerate, strength 1 mg/tablet
Qlaira, dark red tablets, excipient, Hypromellose 2910
Qlaira, dark red tablets, excipient, IRON OXIDE RED (E172)
Qlaira, dark red tablets, excipient, lactose monohydrate
Qlaira, dark red tablets, excipient, Macrogol 6000
Qlaira, dark red tablets, excipient, magnesium stearate
Qlaira, dark red tablets, excipient, maize starch
Qlaira, dark red tablets, excipient, maize starch pregelatinized
Qlaira, dark red tablets, excipient, Povidone K25
Qlaira, dark red tablets, excipient, talc
Qlaira, dark red tablets, excipient, titanium dioxide
Qlaira, dark yellow tablets, active ingredient, estradiol valerate
Qlaira, dark yellow tablets, active ingredient, estradiol valerate, reference strength 3.0 mg/tablet
Qlaira, dark yellow tablets, excipient, hypromellose 2910
Qlaira, dark yellow tablets, excipient, iron oxide yellow
Qlaira, dark yellow tablets, excipient, lactose monohydrate
Qlaira, dark yellow tablets, excipient, Macrogol 6000
Qlaira, dark yellow tablets, excipient, magnesium stearate
Qlaira, dark yellow tablets, excipient, maize starch
Qlaira, dark yellow tablets, excipient, maize starch pregelatinized
Qlaira, dark yellow tablets, excipient, Povidone K25
Qlaira, dark yellow tablets, excipient, talc
Qlaira, dark yellow tablets, excipient, titanium dioxide
Qlaira, light yellow tablets, active ingredient, dienogest
Qlaira, light yellow tablets, active ingredient, dienogest, strength 3 mg/tablet
Qlaira, light yellow tablets, active ingredient, estradiol valerate
Qlaira, light yellow tablets, active ingredient, estradiol valerate, strength 2 mg/tablet
Qlaira, light yellow tablets, excipient, Hypromellose 2910
Qlaira, light yellow tablets, excipient, IRON OXIDE YELLOW
Qlaira, light yellow tablets, excipient, lactose monohydrate
Qlaira, light yellow tablets, excipient, Macrogol 6000
Qlaira, light yellow tablets, excipient, magnesium stearate
Qlaira, light yellow tablets, excipient, maize starch
Qlaira, light yellow tablets, excipient, maize starch pregelatinized
Qlaira, light yellow tablets, excipient, Povidone K25
Qlaira, light yellow tablets, excipient, talc
Qlaira, light yellow tablets, excipient, titanium dioxide
Qlaira, manufactured item, dark red tablets
Qlaira, manufactured item, dark red tablets, product composition
Qlaira, manufactured item, dark yellow tablets
Qlaira, manufactured item, dark yellow tablets, product composition,
Qlaira, manufactured item, light yellow tablets
Qlaira, manufactured item, light yellow tablets, product composition
Qlaira, manufactured item, medium red tablets
Qlaira, manufactured item, medium red tablets, product composition
Qlaira, manufactured item, white tablets (Placebo)
Qlaira, manufactured item, white tablets (Placebo), product composition
Qlaira, medicinal product, film-coated tablets (MP)
Qlaira, medium red tablets, active ingredient, dienogest
Qlaira, medium red tablets, active ingredient, dienogest, strength 2 mg/tablet
Qlaira, medium red tablets, active ingredient, estradiol valerate
Qlaira, medium red tablets, active ingredient, estradiol valerate, strength 2 mg/tablet
Qlaira, medium red tablets, excipient, Hypromellose 2910
Qlaira, medium red tablets, excipient, IRON OXIDE RED (E172)
Qlaira, medium red tablets, excipient, lactose monohydrate
Qlaira, medium red tablets, excipient, Macrogol 6000
Qlaira, medium red tablets, excipient, magnesium stearate
Qlaira, medium red tablets, excipient, maize starch
Qlaira, medium red tablets, excipient, maize starch pregelatinized
Qlaira, medium red tablets, excipient, Povidone K25
Qlaira, medium red tablets, excipient, talc
Qlaira, medium red tablets, excipient, titanium dioxide
Qlaira, package item, 1 x 28 box, as outer packaging
Qlaira, package item 1 x 28 box, container constituent, 1 x 28 tablet blister
Qlaira, package item, 28 tablet blister, as immediate container
Qlaira, package item, 28 tablet blister, container constituent, 17 x light yellow tablets
Qlaira, package item, 28 tablet blister, container constituent, 2 x dark red tablets
Qlaira, package item, 28 tablet blister, constituent, 2 x dark yellow tablets
Qlaira, package item, 28 tablet blister, container constituent, 2 x white tablets
Qlaira, package item, 28 tablet blister, container constituent, 5 x medium red tablets
Qlaira, package item, 3 x 28 box, as outer packaging
Qlaira, package item, 3 x 28 box, container constituent, 3 x 28 tablet blister
Qlaira, package item, 6 x 28 box, as outer packaging
Qlaira, package item, 6 x 28 box, container constituent, 6 x 28 tablet blister
Qlaira, packaged medicinal product, 1 x 28 box
Transparent PVC/Aluminium blister in a cardboard wallet. 1 x 28 tablets film-coated tablets. Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets and 5 medium red tablets and 17 light yellow tablets and 2 dark red tablets and2 white tablets
Qlaira, packaged medicinal product, 3 x 28 box
Transparent PVC/Aluminium blister in a cardboard wallet. 3 x 28 tablets film-coated tablets.Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets and 5 medium red tablets and 17 light yellow tablets and 2 dark red tablets and2 white tablets
Qlaira, packaged medicinal product, 6 x 28 box
Transparent PVC/Aluminium blister in a cardboard wallet. 6 x 28 tablets film-coated tablets.Each wallet (28 film-coated tablets) contains in the following order: 2 dark yellow tablets and 5 medium red tablets and 17 light yellow tablets and 2 dark red tablets and2 white tablets
Qlaira, pharmaceutical product, dark red tablets
Qlaira, pharmaceutical product, dark red tablets, product composition
Qlaira, pharmaceutical product, dark yellow tablets
Qlaira, pharmaceutical product, dark yellow tablets, product composition,
Qlaira, pharmaceutical product, light yellow tablets
Qlaira, pharmaceutical product, light yellow tablets, product composition
Qlaira, pharmaceutical product, medium red tablets
Qlaira, pharmaceutical product, medium red tablets, product composition
Qlaira, pharmaceutical product, white tablets (Placebo)
Qlaira, pharmaceutical product, white tablets as placebo
Qlaira, pharmaceutical product, white tablets (Placebo), product composition
Oral contraception. Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.The decision to prescribe Qlaira should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE),and how the risk of VTE with Qlaira compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Qlaira, white tablets, excipient, hypromellose 2910
Qlaira, white tablets, excipient, lactose monohydrate
Qlaira, white tablets, excipient, Macrogol 6000
Qlaira, white tablets, excipient, magnesium stearate
Qlaira, white tablets, excipient, maize starch
Qlaira, white tablets, excipient, Povidone K25
Qlaira, white tablets, excipient, titanium dioxide
SPOR-RMS, Ingredient Role Vocabulary, List Identifier
SPOR-RMS, Ingredient Role Vocabulary, List Name
SPOR-RMS, Ingredient Role Vocabulary, Active
SPOR-RMS, Ingredient Role Vocabulary, Active, Term Identifier
SPOR-RMS, Ingredient Role Vocabulary, Active, Term Name, English
SPOR-RMS, Ingredient Role Vocabulary, Excipient
SPOR-RMS, Ingredient Role Vocabulary, Excipient, Term Identifier
SPOR-RMS, Ingredient Role Vocabulary, Excipient, Term Name, English
SPOR-RMS, Legal Status for the Supply Vocabulary
SPOR-RMS, Legal Status for the Supply Vocabulary, List Identifier
SPOR-RMS, Legal Status for the Supply Vocabulary, List Name
SPOR-RMS, Legal Status for the Supply Vocabulary, Medicinal product subject to medical prescription
SPOR-RMS, Legal Status for the Supply Vocabulary, Medicinal product subject to medical prescription, Term Identifier
SPOR-RMS, Legal Status for the Supply Vocabulary, Medicinal product subject to medical prescription, Term Name, English
Medicinal product subject to medical prescription
The material list describes the distinct constituents out of which a packaged item or its components is made of. It therefore covers single constituents and combinations of materials are excluded.
SPOR-RMS, Packaging Vocabulary, List Identifier
SPOR-RMS, Packaging Vocabulary, List Name
SPOR-RMS, Packaging Vocabulary, Blister, Term Description, English
Container (usually multidose) consisting of two layers of which one is shaped to contain the individual doses. Strips and unit-dose blisters are excluded.
SPOR-RMS, Packaging Vocabulary, Blister, Term Identifier
SPOR-RMS, Packaging Vocabulary, Blister, Term Name, English
SPOR-RMS, Packaging Vocabulary, Box, Term Description, English
Primary container consisting of one or more parts made of a light material, can be closed.
SPOR-RMS, Packaging Vocabulary, Box, Term Identifier
SPOR-RMS, Packaging Vocabulary, Box, Term Name, English
SPOR-RMS, Pharmaceutical Dose Form Vocabulary
SPOR-RMS, Pharmaceutical Dose Form Vocabulary, List Identifier
SPOR-RMS, Pharmaceutical Dose Form Vocabulary, List Name
SPOR-RMS, Pharmaceutical Dose Form Vocabulary, Film-coated tablet
SPOR-RMS, Pharmaceutical Dose Form Vocabulary, Film-coated tablet, Term Identifier
SPOR-RMS, Pharmaceutical Dose Form Vocabulary, Film-coated tablet, Term Name, English
SPOR-RMS, Units of Presentation Vocabulary
SPOR-RMS, Units of Presentation Vocabulary, List Identifier
SPOR-RMS, Units of Presentation Vocabulary, List Name
SPOR-RMS, Units of Presentation Vocabulary, Blister
SPOR-RMS, Units of Presentation Vocabulary, Blister, Term Identifier
SPOR-RMS, Units of Presentation Vocabulary, Blister, Term Name, English
SPOR-RMS, Units of Presentation Vocabulary, Tablet
SPOR-RMS, Units of Presentation Vocabulary, Tablet, Term Identifier
SPOR-RMS, Units of Presentation Vocabulary, Tablet, Term Name, English
SPOR-RMS, Material Vocabulary, List Identifier
SPOR-RMS, Material Vocabulary, List Name
SPOR-RMS, Material Vocabulary, Aluminium
SPOR-RMS, Material Vocabulary, Aluminium, Term Identifier
SPOR-RMS, Material Vocabulary, Aluminium, Term Name, English
SPOR-RMS, Material Vocabulary, PolyVinyl Chloride
SPOR-RMS, Material Vocabulary, PolyVinyl Chloride, Short Name, English
SPOR-RMS, Material Vocabulary, PolyVinyl Chloride, Term Identifier
SPOR-RMS, Material Vocabulary, PolyVinyl Chloride, Term Name, English
SPOR-RMS, Material Vocabulary, Cardboard
SPOR-RMS, Material Vocabulary, Cardboard, Term Identifier, English
SPOR-RMS, Material Vocabulary, Cardboard, Term Name, English
SPOR-RMS, Medicinal Product Type Vocabulary, Authorised Medicinal Product
SPOR-RMS, Medicinal Product Type Vocabulary, Authorised Medicinal Product, Term Identifier
SPOR-RMS, Medicinal Product Type Vocabulary, Authorised Medicinal Product, Term Name, English
SPOR-SRS, Povidone K25, Term Name, English
SPOR-SRS, Macrogol 6000, Term Identifier
SPOR-SRS, Macrogol 6000, Term Name, English
SPOR-SRS, IRON OXIDE YELLOW (E 172), Term Identifier
SPOR-SRS, IRON OXIDE YELLOW (E 172), Term Name, English
SPOR-SRS, MAIZE STARCH PREGELATINISED, Term Identifier
SPOR-SRS, MAIZE STARCH PREGELATINISED, Term Name, English
SPOR-SRS, Maize starch, Term Name, English
SPOR-SRS, Hypromellose 2910, Term Identifier
SPOR-SRS, Hypromellose 2910, Term Name, English
SPOR-SRS, IRON OXIDE RED (E172), Term Identifier
SPOR-SRS, IRON OXIDE RED (E172), Term Name, English
SPOR-SRS, Magnesium stearate, Term Identifier
SPOR-SRS, Magnesium stearate, Term Name, English
SPOR-SRS, Estradiol valerate, Molecular Formula
SPOR-SRS, Estradiol valerate, Molecular Structure
SPOR-SRS, Estradiol valerate, Term Identifier
SPOR-SRS, Estradiol valerate, Term Name, English
SPOR-SRS, Titanium dioxide, Term Identifier
SPOR-SRS, Titanium dioxide, Term Name, English
SPOR-SRS, Aluminium, Molecular Structure
SPOR-SRS, Lactose monohydrate, Term Identifier
SPOR-SRS, Lactose monohydrate, Term Name, English
SPOR-SRS, Poly(vinyl chloride), Other Name, English, POLYVINYL CHLORIDE
SPOR-SRS, Poly(vinyl chloride), Term Identifier
SPOR-SRS, Poly(vinyl chloride), Term Name, English
SPOR-SRS, Polyvinylidene chloride, Other Name, English, PVDC
SPOR-SRS, Polyvinylidene chloride, Other Name, English, Poly(1,1-dichloroethene)
SPOR-SRS, Polyvinylidene chloride, Term Identifier
SPOR-SRS, Polyvinylidene chloride, Term Name, English