ISO/TR 23022:2018

Traditional Chinese medicine - Controlled vocabulary on Japanese Kampo formulas and the indication codes for the products

ISO/TR 23022:2018 specifies the controlled vocabulary for formulas used in Japanese Kampo medicine with the therapeutic indications of each product according to the subset of IDMPs (ISO 11238, ISO 11615, ISO 11616[10], ISO 19844[15], ISO/TS 20443[16], ISO/TS 20451[17]). ISO/TR 23022:2018 is intended to be used by: - traders and distributors of medicinal products in Kampo formulas and crude drugs used in Kampo medicine; - terminologists and developers of new terminological resources concerning herbal medicines in Kampo medicine, and maintenance officers of existing terminological resources concerning Kampo medicine to enable their conformance; - informaticians, developers, or managers of HIS, EMR, or EHR systems concerning Kampo medicine; - officers, analysts or maintenance personnel of national health statistics, and policy proposal staff of national health policies; - officers of WHO, and WHO statistics. This edition of ISO/TR 23022:2018 describes only medicinal products in accordance with the Kampo formula in Japan. Both OTC Kampo formula medicinal products and in-pharmacy formula medicinal products are omitted, although they are permitted under Japanese jurisdiction. Topics considered out of scope of this document are: - any medicinal products manufactured in accordance with the formula of traditional medicines that are not permitted under the Japanese jurisdiction; - whole information models of medicinal products, pharmaceutical products and substances (see ISO 11238) because those are already specified in IMDPs; - any categorical structure(s) of herbal medicaments (see ISO/TS 18062, ISO 17115[13] and EN 12264[18]). The controlled vocabulary for formulas used in Japanese Kampo medicine is given in Annex A.

Médecine traditionnelle chinoise - Vocabulaire contrôlé relatif aux formules Kampo japonaises et codes d'indication des produits

General Information

• Status: Published
• Publication Date: 23-Apr-2018
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 24-Apr-2018
• Due Date: 02-Aug-2020
• Completion Date: 02-Aug-2020

Overview

ISO/TR 23022:2018 - Traditional Chinese medicine - Controlled vocabulary on Japanese Kampo formulas and the indication codes for the products - defines a standardized, controlled vocabulary for Kampo formulas used in Japan and provides therapeutic indication codes aligned with a subset of the IDMP family of standards. The technical report helps remove ambiguity in formula names and indications to support consistent identification, exchange and management of Kampo medicinal product information.

Key topics and technical requirements

• Controlled vocabulary for Kampo formulas: Annex A contains the authoritative list of Kampo formula names and their mapped indication codes (the controlled vocabulary is informative and intended for adoption by systems and terminologists).
• Indication coding aligned with IDMP: Indication codes follow a subset of IDMP standards (ISO 11238, ISO 11615, ISO 11616, ISO 19844, ISO/TS 20443 and ISO/TS 20451) to ensure compatibility with international medicinal product identification and data-exchange models.
• Scope limitations: This edition covers medicinal products formulated in accordance with Kampo formulas authorized in Japan. It omits OTC Kampo products and in-pharmacy formulations (although those are permitted under Japanese law) and excludes products not authorized under Japanese jurisdiction.
• Out-of-scope areas: Whole information models for medicinal products and categorical structures for herbal medicaments are not defined here (see ISO 11238, ISO/TS 18062, ISO 17115, EN 12264 for those topics).
• Terminology and definitions: The report defines key terms such as medicinal product, kampo formula, crude drug, manufactured item, therapeutic indication, and jurisdictional/legal status to support consistent usage.

Practical applications and who uses it

ISO/TR 23022:2018 is practical for organizations needing consistent Kampo product naming and indication data:

• Regulatory authorities and market access teams - to harmonize product listings and indication descriptions for Kampo medicinal products.
• Pharmaceutical traders and distributors - to prevent market distortions by using standardized formula names and indication codes.
• Terminologists and ontology developers - to create or maintain terminological resources and ensure conformance with international standards.
• Health informatics professionals (HIS, EMR, EHR developers) - to integrate Kampo product data into clinical systems using IDMP-compatible codes.
• Public health and statistics offices, WHO - for reliable aggregation, reporting and policy analysis involving Kampo medicines.
• Pharmacovigilance and safety monitoring - to enable accurate identification of products during safety reporting and PSUR activities.

Related standards

• IDMP and medicinal product identification: ISO 11238, ISO 11615, ISO 11616, ISO 19844, ISO/TS 20443, ISO/TS 20451
• Herbal medicament representation and categorial structures: ISO/TS 18062, ISO 17115, EN 12264

Using ISO/TR 23022:2018 supports interoperability, regulatory clarity and safer international trade and information exchange for Japanese Kampo medicinal products.

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 23022
First edition
2018-04
Traditional Chinese medicine —
Controlled vocabulary on Japanese
Kampo formulas and the indication
codes for the products
Médecine traditionnelle chinoise - Vocabulaire contrôlé relatif aux
formules Kampo japonaises et codes d'indication des produits
Reference number
©
ISO 2018
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviated terms . 5
5 Conformance . 6
6 Coding system . 6
Annex A (informative) Controlled vocabulary of Japanese Kampo formulas .8
Bibliography .87
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2018 – All rights reserved

Introduction
Herbal medicines have been developed around the world by utilizing available vegetation to develop
uses suitable for the physical constitution of the target population in each area.
Consequently, herbal prescriptions with the same name sometimes have different qualitative
composition and quantitative composition strength in different parts of the world. In other words,
there are plenty of polysemes (see ISO 1087-1) in the origin of crude drugs among some traditional
[20] [12]
medicines . The resulting confusion is further complicated by the use of similar letters in some
countries.
These issues cannot be ignored in the process of standardizing contemporary terminology for medicinal
products to keep with up-to-date drug information management policies, from clinical trials to post-
market surveillance in the periodic safety update report (PSUR).
Furthermore, therapeutic indications are defined only for medicinal products, but not for formulas
[21][22]
specified in some pharmacopoeias including Japan’s . It is important to take this into account in
international standardization though this has not yet been achieved in ISO/TC 249.
Therefore, this document describes the controlled vocabulary for formula names used in Japanese
Kampo formulas with the respective indications and efficacies of each product to avoid market
distortions and health hazards. The information provided in this document is expected to encourage
international trade.
Formulas or traditional medicines that are not controlled by the Japanese Pharmacopoeia and the
related official documents published by the Medicinal Regulatory Agency in Japan are beyond the scope
of this document.
TECHNICAL REPORT ISO/TR 23022:2018(E)
Traditional Chinese medicine — Controlled vocabulary on
Japanese Kampo formulas and the indication codes for the
products
1 Scope
This document specifies the controlled vocabulary for formulas used in Japanese Kampo medicine with
the therapeutic indications of each product according to the subset of IDMPs (ISO 11238, ISO 11615, ISO
[10] [15] [16 [17]
11616 , ISO 19844 , ISO/TS 20443 ], ISO/TS 20451 ).
This document is intended to be used by:
— traders and distributors of medicinal products in Kampo formulas and crude drugs used in Kampo
medicine;
— terminologists and developers of new terminological resources concerning herbal medicines in
Kampo medicine, and maintenance officers of existing terminological resources concerning Kampo
medicine to enable their conformance;
— informaticians, developers, or managers of HIS, EMR, or EHR systems concerning Kampo medicine;
— officers, analysts or maintenance personnel of national health statistics, and policy proposal staff of
national health policies;
— officers of WHO, and WHO statistics.
This edition of this document describes only medicinal products in accordance with the Kampo formula
in Japan. Both OTC Kampo formula medicinal products and in-pharmacy formula medicinal products
are omitted, although they are permitted under Japanese jurisdiction.
Topics considered out of scope of this document are:
— any medicinal products manufactured in accordance with the formula of traditional medicines that
are not permitted under the Japanese jurisdiction;
— whole information models of medicinal products, pharmaceutical products and substances (see ISO
11238) because those are already specified in IMDPs;
[13]
— any categorical structure(s) of herbal medicaments (see ISO/TS 18062, ISO 17115 and EN
[18]
12264 ).
The controlled vocabulary for formulas used in Japanese Kampo medicine is given in Annex A.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1087-1, Terminology work — Vocabulary — Part 1: Theory and application
ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated information on substances
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information
ISO/TS 18062, Health informatics — Categorial structure for representation of herbal medicaments in
terminological systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1087-1, ISO 11238, ISO 11615
and ISO/TS 18062 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at https: //www .electropedia .org/
3.1
ingredient
material (3.8) that is used in the preparation of a medicinal product (3.9)/pharmaceutical product (3.13)
Note 1 to entry: An ingredient is a part of a medicinal product (3.9), either by itself or in combination with one or
more ingredients. An ingredient is also a component of a pharmaceutical product (3.13). An ingredient is equal to
a detailed description of a substance playing a role in a product.
3.2
jurisdiction
geographical area or subject matter in which the authority of the Medicines Regulatory Agency applies
3.3
legal status of supply
jurisdictional rule on whether a medicinal product requires a medical prescription before it can be
supplied to a patient or consumer
3.4
manufactured item
qualitative and quantitative composition of a product as described in the packaging of the medicinal
product (3.9)
Note 1 to entry: A medicinal product may contain one or more manufactured items.
Note 2 to entry: Pharmaceutical product (3.13) and manufactured item are sometimes different when
manufactured item(s) are processed before administration to the patient (as the pharmaceutical product).
Note 3 to entry: The manufactured item is not in direct contact with the outer packaging except where the outer
packaging also serves as the immediate container.
3.5
marketing authorization
authorization issued by a Medicines Regulatory Agency allowing a medicinal product (3.9) to be sold on
the market
3.6
marketing authorization holder
organization that holds the authorization for marketing a medicinal product in a jurisdiction
3.7
marketing authorization number
identifier assigned by a Medicines Regulatory Agency to a medicinal product (3.9)
2 © ISO 2018 – All rights reserved

3.8
material
substance or a specified substance of which a certain component is made
Note 1 to entry: This applies to medicinal products (3.9), packaging items (container), packages (component), and
devices.
3.9
medicinal product
any substance or combination of substances that may be administered to human beings (or animals)
to treat or prevent disease, to make a medical diagnosis, or to restore, correct, or modify physiological
functions
Note 1 to entry: A medicinal product may contain one or more manufactured items, and one or more
pharmaceutical products (3.13).
Note 2 to entry: In certain jurisdictions, a medicinal product may also be defined as any substance or a
combination of substances that may be used to make a medical diagnosis.
Note 3 to entry: [SOURCE: ENV 13607:2000, modified]
3.10
medicinal product identifier
MPID
unique identifier allocated to a medicinal product that supplements any existing marketing authorization
number as ascribed by a Medicines Regulatory Agency within a jurisdiction
Note 1 to entry: This identifier is for indexing purposes to contribute to improved patient safety by allowing for
the unique identification of medicinal products worldwide.
3.11
medicinal product name
name as authorized by a Medicines Regulatory Agency
Note 1 to entry: This may either be an invented name not liable to be confused with the common name, or a
common or a scientific name accompanied by a trademark or any other applicable descriptor.
3.12
medicines regulatory agency
institutional body that, according to the legal system under which it has been established, is responsible
for the granting of marketing authorization for medicinal products
Note 1 to entry: In certain jurisdictions, the role of the institutional body, which grants the marketing
authorization of medicinal products according to the legal system, may be complemented by an additional
institutional body responsible for the evaluation and supervision of medicinal product. For example, in the
EU, the European Commission is the institutional body that grants the marketing authorization of medicinal
products, and the European Medicines Agency is the body responsible for the evaluation and supervision of
medicinal products.
3.13
pharmaceutical product
qualitative and quantitative composition of a medicinal product in the dose form approved for
administration in line with regulated product information
Note 1 to entry: A medicinal product can contain one or more pharmaceutical products.
Note 2 to entry: Pharmaceutical product and manufactured item (3.4) are sometimes different when manufactured
item(s) are processed before administration to the patient [as the pharmaceutical product (3.13)].
3.14
pharmaceutical product identifier
PhPID
unique identifier for a pharmaceutical product
3.15
product classification
categorization or grouping of medicinal products based on specific properties
EXAMPLE Pharmacological classification, classification by therapeutic effect.
3.16
qualitative composition
composition of all the constituents of the investigational or authorized medicinal product, if applicable,
after reconstitution, and the functioning of the constituents of:
— the substance and the specified substance;
— the constituent(s) of the excipients, whatever their nature or quantity used, including colouring
materials, preservatives, adjuvants, stabilizers, thickeners, emulsifiers, flavouring, and aromatic
substances, etc.
3.17
quantitative composition strength
amounts of substance and specified substance constituents in the investigational or authorized
medicinal product expressed in a ratio scale
Note 1 to entry: It is necessary for the quantitative composition of the substance(s) or the specified substance
descriptions of the finished investigational or authorized medicinal products (depending on the pharmaceutical
form concerned) to specify the mass, or the number of units of biological activity, either as a per dosage unit or as
per unit of mass or volume, of each substance or specified substance.
Note 2 to entry: Substance or specified substance descriptions present in the form of compounds or derivatives
are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of the active
entity, or entities, of the molecule.
3.18
target population
type of patients or consumers for which the indication of a medicinal product (3.9) is authorized
3.19
therapeutic indication
intended use of the medicinal product (3.9) as authorized by the Medicines Regulatory Agency in a
jurisdiction
Note 1 to entry: For clinical trials, this refers to the intended use under investigation and as described in the
clinical trial protocol.
3.20
Kampo
kampo medicine
traditional medicine that has been developed in Japan
Note 1 to entry: Ancient Chinese medicine was introduced to Japan. After around 1 600 years, Kampo medicine
has diverged from the ancient Chinese medicine.
3.21
kampo formula
combination of crude drugs (3.24) used in Kampo medicine (3.20), that is defined or authorized by the
[21][22][23]
Medicines Regulatory Agency and in Japan
Note 1 to entry: Medicinal products (3.9) made with this type of formula are supplied only when modern medical
doctors order prescriptions. Cf. legal status of supply (3.3).
4 © ISO 2018 – All rights reserved

3.22
OTC kampo formula
combination of crude drugs (3.24) based on Kampo medicine (3.20), that is defined or authorized by the
[21][22][23]
Medicines Regulatory Agency in Japan
Note 1 to entry: Medicinal products (3.9) in accordance with this type of formula are supplied for the use of self-
medication. Cf. legal status of supply (3.3).
3.23
in-pharmacy Kampo formula
combination of crude drugs based on Kampo medicine, defined or authorized by the Medicines
Regulatory Agency in Japan
Note 1 to entry: Medicinal products (3.9) in accordance with this type of formula are produced in pharmacies. Cf.
legal status of supply (3.3).
3.24
crude drug
natural medicine that is used as a component of a Kampo formula (3.21) defined or authorized in the
[21][22]
Japanese Pharmacopeia and its addenda
3.25
part of interest
medicinal part
part of a natural material (3.8) that is usable as source material for a crude drug (3.24)
EXAMPLE Seed, root, rhizome, stem, bark, leaf, bud, flower, fruit.
3.26
origin
definition of crude drug (3.24) including the name of the natural material (3.8) and the part of interest
for medicinal use
3.27
medical domain
specific concepts and generic concepts of various medical systems
Note 1 to entry: Modern medicine is also a type of medical domain.
EXAMPLE Modern medicine, Ayurveda, traditional African medicine, traditional Australian (Aboriginal),
traditional Canadian, Chinese or traditional Chinese (TCM), traditional Japanese (Kampo), traditional Korean,
Mongolian, New Zealand (Maori), Thailand, Tibetan, or Vietnamese, and so on.
Note 2 to entry: Other country's pharmacopeia(s) or portion(s) of it may substantially indicate a certain
medical domain.
3.28
batch
specific manufacturing release of a medicinal product (3.9) or item by the manufacturer
4 Abbreviated terms
BAID_1 Medicinal Product Batch Identifier (outer packaging)
BAID_2 Medicinal Product Batch Identifier (immediate packaging)
5 Conformance
The Japanese jurisdiction claims the following:
— crude drugs and pharmaceutical products using the Kampo formula shall conform to the Japanese
[21][22];
Pharmacopeia and its addenda
— medicinal products using the Kampo formula shall conform to the Japanese Pharmacopeia and its
[21][22]
addenda ;
— the medicinal product names of Kampo formula and their expression with letters shall conform to
[21]21]
the Japanese Pharmacopeia and its addenda .
NOTE 1 Chemical and physical identification methods for substances in Kampo medicine are described in
[21][22]
the Japanese Pharmacopeia and its addenda . Some examples of these methods as well as genetic data are
accessible from the website of the Research Center for Medicinal Plant Resources of the National Institute of
[24]
Biomedical Innovation .
[20][21][22]
NOTE 2 Many crude drug names in traditional medicines are polysemes. Such confusion is further
[3]
aggravated by the use of similar letters or scripts in various countries.
NOTE 3 To avoid confusion caused by similarities in naming, the names of the Kampo formula defined by
[21][22][23]
the Japanese Medicines Regulatory Authority are expressed with a superscript symbol . Such a

symbol has three purposes: 1) to give attention to the recognition of the different meaning, 2) to prohibit
inaccurate conversion of letters, and 3) to help distinguish between homonyms and polysemes (see ISO 1087-1
and References [1][2][3] and [12].
NOTE 4 Each medicinal product name using the Kampo formula contains names defined by the Japanese
[21][22][23]
Medicines Regulatory Authority . In other words, medicinal product names using the Kampo formula
in the same product classification contains the name of the Kampo formula defined by the Japanese Medicines
[21][22][23]
Regulatory Authority .

EXAMPLE 1 The symbol is added as superscript to the Latin name of crude drugs used in Kampo medicine
in this document in order to distinguish crude drugs in Kampo medicine from those in the Chinese Materia
[14] [21]
Medica , 3.86. For example, the Latin name BUPLEURI RADIX , 7.2.29, is defined as the root of Bupleurum
[14]
falcatum Linné (Umbelliferae), but the Latin name of Bupleuri radix in the Chinese Materia medica , 3.86, is
defined as the root of Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd.

EXAMPLE 2 ANGELICAE RADIX , Japanese Angelica Root , and 当当 is defined as the root of Angelica
acutiloba Kitagawa or Angelica acutiloba Kitagawa var. sugiyamae Hikino (Umbelliferae), usually after being
[14]
passed through hot water (7.2.9 in Reference [21]). This is different from 当当in the Chinese Materia medica ,
3.38, which is defined as the root of Angelica sinensis (Oliv.) Diels.
6 Coding system
ISO 11615 requires the description of the concepts of MPID with PhPID(s), BAID_1, and BAID_2. Those
mainly focus on the following entries:
— name of the medicinal product;
— legal status of supply;
— terms of the marketing authorization;
— marketing authorization (licence) holder;
— manufacturer(s);
— authorizing Medicines Regulatory Agency;
— qualitative and quantitative compositions;
— ingredients, strength, pharmaceutical form, route of administration;
6 © ISO 2018 – All rights reserved

— device(s) as part of a medicinal product;
— clinical particulars, especially authorized therapeutic indication(s);
— product classification(s);
— package description;
— regulated product information and documentation.
It is explicitly or implicitly expected that the above are described with the following:
[6][7][8]
— country code ;
— the marketing authorization number;
— unique identification of a medicinal product and the associated PhPID(s).
Annex A
(informative)
Controlled vocabulary of Japanese Kampo formulas
A.1 Names and the specifics of Japanese Kampo formulas
This document covers only Kampo medicine. In Japan, the Medicines Regulatory Agency is the Ministry
of Health, Labour, and Welfare (of Japan).
Authorized formulas and their names are defined in Japanese Pharmacopeia, its official addenda and
[21][22]
related document . Some formula has variation in qualitative and quantitative composition.
Qualitative and quantitative composition is simply expressed as the composition of crude drugs and
their amount in weight.
The Kampo formulas consist of some crude drugs, and both of them are defined in Japanese
[21][22]
Pharmacopeia and its official addenda . The definitions of crude drug are not only specifying
scientific names of the origins and the part of interest(s) but also laboratory tests and test methods.
The “approved number” are able to use as the marketing authorization number. The minister or
the prefectural governors hold the authority to provide those numbers, and this information is also
embedded in the marketing authorization number.
Authorized names of medicinal products in Kampo medicinal product are expressed in Japanese
Katakana, Hiragana, Kanji letters, and English text.
[21][22]
No therapeutic indications are specified in Japanese Pharmacopeia and in its official addenda .
One reason is that medicinal products are manufactured with various ingredients other than active
substances (ISO 1087-1, References [7] and [8]). Consequently, the characteristics of medicinal products
are different from each other although they are manufactured conforming to the same formula and then
they are belonging to the same product classification. Another reason is because therapeutic indications
and contra-indications are immediately updated on the results of “post marketing surveillance” in Japan.
In this document, therapeutic indications are described in English text as well as ICD codes that are
linked from the “medical insurance reimbursement code in Japan” used in EMR systems or HIS.
Table A.1 — Summary of fixed values for indication coding of medicinal products in Kampo
in Japan
fixed: the Ministry of Health, La-
authorizing Medicines Regulatory Agency
bour, Welfare
with country code fixed: Japan
name of authorized formula
with country code fixed: Japan
authorized qualitative and quantitative
composition
and its authorized variation, if existing
embedded in marketing authoriza-
tion number.
marketing authorization (licence) holder
actually fixed for the medicinal
product for Kampo formula, the
Minister of MHLW.
8 © ISO 2018 – All rights reserved

Table A.1 (continued)
embedded in marketing authoriza-
tion number.
maybe with subdivision code
actually used for the medicinal prod-
uct fonly for OTC Kampo formula.
marketing authorization number for me-

dicinal product
substituted by marketing authoriza-
unique identifier of a medicinal product
tion number.
authorized name of the medicinal product
in conformance with qualitative and
actual composition
quantitative composition
manufacturer includes VAR
with country code
authorized therapeutic indications for

medicinal product
scope for therapeutic indications —
country code fixed: Japan
medical domain fixed: modern medicine
Indication text
Indication as “disease/symptom/proce-

dure”
A.2 Binding indications to each medicinal product of Japanese Kampo formula
A.2.1 Presented items, notes, and sources
The fixed value items in Table A.1 are omitted, then, presented items (bold-faced), notes, and
information sources are illustrated in Table A.2.
Table A.2 — Presented items (bold-faced), notes, and information sources
Japanese Pharmacopeia, its addenda
name of authorized formula
[21][22][23]
and related document .
authorized qualitative and quantitative Japanese Pharmacopeia, its addenda
[21][22][23]
composition and related document , this
and its authorized variation, if existing item is not presented in A.2.2.
package insert in each medicinal
[15][16][17]
product .
marketing authorization number for me-
surrogate for unique identifier of a
dicinal product
medicinal product, this item is shown
as the anonymous number in A.2.2.
package insert in each medicinal
[15][16][17]
authorized name of the medicinal product product , this item is not
presented in A.2.2.
in conformance with authorized
actual composition composition, expressed as composi-
[21][22]
tion of crude drugs .
package insert in each medicinal
[15][16][17]
manufacturer product , this item is not
presented in A.2.2.
with country code fixed: Japan
Table A.2 (continued)
authorized therapeutic indications for package insert in each medicinal
[15][16][17]
medicinal product product .
package insert in each medicinal
Indication text
[15][16][17]
product .
Indications as “disease/symptom/pro-
Compendiums of Kampo medi-
cedure”
[25][26][27]
cines .
with controlled terms/identifiers
In the tables under A.2.2, each Kampo medicinal product is classified in the Clause of corresponding
Kampo formula. Each Clause has two tables: One is for indications, and the other illustrates the
composition of each Kampo medicinal product.
In the first table, the values of “Controlled identifiers” are paired: the former one is “the codes used
in Hospital Information Systems in Japan” and these codes are used for reimbursement of medical
[27]
insurance. The latter one is ICD-10 code that is mapped from the former code .
In the second table, “Product No.” is the anonymous number for the actual marketing authorization
[27]
number of Kampo medicinal products regulated in the Medicinal Regulatory Agency in Japan .
“Indication” means the categories of the therapeutic indications. Then, the compositions of crude
drugs are shown with quantity in the weight (g) if it is solid or the volume (ml) if it is liquid at room
temperature in the prescription of daily dosage. The name of each crude drug is regulated in the
[21][22]
Medicinal Regulatory Agency in Japan . Please note better that the same names that are defined
[14]
by other Medicinal Regulatory Agencies do not always designate a same crude drug . Therefore,

whole of the crude drugs used in Kampo medicinal products are superscripted with the symbol .
A.2.2 Japanese Kampo formulas and the indications of their medicinal products
A.2.2.1 Anchusan
Indications Indications text Controlled identifiers
A The following symptoms of those patients 7832001/R634, 8830562/R101, 8839710/
of the leptosome type whose abdominal R104, 7871001/R12, 8830990/R14,
muscles tend to relax and who have stom- 7830003/R630, 7870012/R11, 3064021/F54,
achache or abdominal pain sometimes 3009007/F489, 8830417/K297, 5351003/
accompanied by heartburn, belching, K295, 8844662/K318, 7865013/R101,
anorexia, nausea, etc.: Nervous gastritis, 8844737/R198
chronic gastritis, and gastric atony
B The following symptoms of those patients 8839176/R688, 8834942/R450, 8830562/
with poor circulation, nervousness, stom- R101, 7871001/R12, 8830417/K297,
achache, and heartburn: Gastrointestinal 8831204/K318, 5319009/K259, 7865013/
disease, gastritis, hyperchlorhydria, and R101, 8844737/R198
stomachache due to gastric ulcer
10 © ISO 2018 – All rights reserved

Prod- Indi- Cinna- Cinna- Cory- Oyster Fen- Amo- Gly- Al-
<- <-
uct ca- mon mon dalis Shell nel mum cyr- pinia
<- <- JP> JP> <- <-
No. tions Bark Twig Tu- Seed rhiza Offici-
JP> JP> <- JP> JP>
ber nar-
JP>
um
Rhi-
<-
zome
JP>
1 A 5,0 4,0 4,0 2,0 1,5 1,5 0,7
2 A 4,0 3,0 3,0 1,5 1,0 1,0 0,5
3 B 4,0 3,0 3,0 1,5 1,0 1,0 0,5
4 A 4,0 3,0 3,0 1,5 1,0 1,0 1,0
5 A 3,0 3,0 3,0 2,0 2,0 2,0 1,0
A.2.2.2 Bakumondoto
Indications Indications text Controlled identifiers
A Coughing with a hard, obstructive sputum, 7869009/R093, 8831159/R093,
bronchitis, and bronchial asthma 7862008/R05, 4900009/J40, 4939008/
J459, 8844664/R098, 8830642/F453
B The following symptoms of those patients 7862008/R05, 8831159/R093, 7869009/
with hard coughing accompanied by redness R093, 7864002/R042, 8844802/
of face, a small amount of viscous sputum, R232, 8844710/R682, 3061005/
difficulty of expectoration, occasional bloody F453, 7849002/F453, 8830642/F453,
sputum or thirst due to hot flush and sen- 8847726/F458, 4900009/J40, 4939008/
sation of foreign body in larynx: Bronchitis, J459,8844664/R098
bronchial asthma, and cough in chest disease
<-
Product Indica- Ophiopogon Tu- Pinellia Tu- Brown Jujube Gin- Glycyr-
JP>
No. tions ber ber Rice seng rhiza
1 A 10,0 5,0 5,0 3,0 2,0 2,0
2 B 10,0 5,0 5,0 3,0 2,0 2,0
A.2.2.3 Bofutsushosan
Indications Indications text Controlled identifiers
A The following symptoms of those patients 8840042/K590, 8833421/I10, 7851005/
with thick subcutaneous fat in the abdomen R002, 8831347/M6281, 8844802/R232,
and a tendency to constipation: Accessory 8839404/E669, 7823024/R609
symptoms associated with hypertension (pal-
pitation, shoulder stiffness, and hot flushes),
obesity, swelling, and constipation
B The following symptoms of those patients 8839404/E669, 8840042/K590,
with thick subcutaneous fat, constipation, and 7885005/R34, 5640018/K590,
decreased urinary output: Chronic constipa- 8831204/K318, 5839010/N059,
tion, hyperchlorhydria, kidney disease, car- 8844106/N289, 4289018/I509,
diac debility, arteriosclerosis, hypertension, 8838263/I709, 8833421/I10, 4369009/
cerebral haemorrhage, and shoulder stiffness I64, 8831347/M6281
due to these diseases
C The following symptoms of those patients 8840042/K590, 7871001/R12,
with thick subcutaneous fat who have 8831347/M6281, 7885005/R34,
constipation, or pyrosis, shoulder stiffness, 8839404/E669, 8833421/I10, 5640018/
decreased urine volume, etc.: Obesity, hyper- K590, 4556002/I849, 5829003/N039,
tension, chronic constipation, hemorrhoids, 5839010/N059, 6923002/L309
chronic nephritis, and eczema
12 © ISO 2018 – All rights reserved
Prod- Indica- Japa- Peony Cnid- Gar- For- Men- Gin- Fresh Schizo- Saposh- Gleh- Ephe- Rhu- Sodi- Anhy- Atrac- Platy- Scute- Glycyr- Gyp- Alu-
<- <- <- <-
uct No. tions nese Root ium denia sythia tha ger Gin- nepeta niko- nia dra barb um drous tylodes codon llaria rhiza sum min-
JP> <- <- <- <- <- JP> <- <- JP> JP>
An- Rhi- Fruit Fruit Herb ger Spike via Root Herb Sulfate Sodi- Rhi- Root Root ium
<- JP> JP> JP> JP> JP> <- JP> JP>
gelica zome Root and Hy- um zome Silicate
<- JP> <- JP>
Root and Rhi- drate Sul- Hy-
JP> <- JP> <-
Rhi- zome fate drate
<- JP> JP>
zome with
JP>
Silicon
Diox-

ide
1 A 1,2 1,2 1,2 1,2 1,2 1,2 0,4 1,2 1,2 1,2 1,5 1,5 2,0 2,0 2,0 2,0 2,0 3,0
2 A 1,2 1,2 1,2 1,2 1,2 1,2 0,3 1,2 1,2 1,2 1,5 1,5 2,0 2,0 2,0 2,0 2,0 3,0
3 B 1,2 1,2 1,2 1,2 1,2 1,2 0,3 1,2 1,2 1,2 1,5 0,7 2,0 2,0 2,0 2,0 2,0 3,0
4 A 1,2 1,2 1,2 1,2 1,2 1,2 0,4 1,2 1,2 1,2 1,5 0,75 2,0 2,0 2,0 2,0 2,0 3,0
5 A 1,2 1,2 1,2 1,2 1,2 1,2 0,3 1,2 1,2 1,2 1,5 0,7 2,0 2,0 2,0 2,0 2,0 3,0
6 C 1,2 1,2 1,2 1,2 1,2 1,2 0,3 1,2 1,2 1,2 1,5 0,75 2,0 2,0 2,0 2,0 2,0 3,0
7 A 1,2 1,2 1,2 1,2 1,2 1,2 1,2 1,2 1,2 1,2 1,5 1,5 2,0 2,0 2,0 2,0 2,0 3,0
8 A 1,2 1,2 1,2 1,2 1,2 1,2 1,2 1,2 1,2 1,2 1,5 1,5 2,0 2,0 2,0 2,0 2,0 3,0
9 A 1,2 1,2 1,2 1,2 1,2 1,2 0,3 1,2 1,2 1,2 1,5 0,7 2,0 2,0 2,0 2,0 2,0 3,0

A.2.2.4 Boiogito
Indications Indications text Controlled identifiers
A The following symptoms of those patients with a 8839426/R53, 7808004/R619,
white-complexion who are easily fatigued and perspire 8839404/E669, 7194005/M2559,
profusely: Obesity (with soft muscles and a flabby 7823024/R609
constitution), arthralgia, and oedema
B The following symptoms of those patients with a 8839426/R53, 7808004/R619,
white-complexion, flabby constitution who are easily 7823024/R609, 7169005/M1399,
fatigued, perspire profusely and develop oedema: Ar- 8842106/M0690, 8839404/E669
thritis, rheumatoid arthritis, obesity, and hyperhidrosis
C The following symptoms of those patients with a 8839426/R53, 7808004/R619,
white-complexion, soft muscles, a flabby constitution 8844729/R34, 7823024/R609,
who are easily fatigued, perspire profusely, do not 5839010/N059, 5819004/N049,
excrete enough urine, and develop oedema in the lower 6462001/O268, 8843650/N433,
limbs and swelling and pain of the knee joint: Nephri- 8839404/E669, 7169005/M1399,
tis, nephrosis, nephropathy of pregnancy, hydrocele 6809003/L029, 6809001/L029,
testis, obesity, arthritis, carbuncle, furuncle, myositis, 7280003/M6099, 8833261/N926
oedema, dermatosis, hyperhidrosis, and menstrual
irregularity
<- <-
Prod- Indica- Sinomeni- Astra- Atracty- Atrac- Ginger Jujube Glycyr-
JP> JP>
uct No. tions um Stem galus lodes Rhi- tylodes rhiza

and Rhi- Root zome Lancea Rhi-

zome zome
1 A 5,0 5,0 3,0 1,0 3,0 1,5
2 A 5,0 5,0 3,0 1,0 3,0 1,5
3 B 5,0 5,0 3,0 0,8 3,0 1,5
4 C 5,0 5,0 3,0 1,0 3,0 1,5
A.2.2.5 Bukuryoin
Indications Indications text Controlled identifiers
A The following symptoms of those patients 8844736/R198, 8830416/K318, 7870002/R11,
with blocked feeling in the stomach, 8830971/R11, 7830003/R630, 7885005/R34,
stomach fullness, excessive gastric 8830417/K297, 8830420/K318, 8844662/K318,
fluid, nausea, vomiting, anorexia, and 3064002/F453, 5351003/K295, 3009007/F489,
decreased urinary output: Gastritis, gas- 5368008/K318, 8844663/R198, 8834689/K30,
troptosis, gastric atony, gastric neurosis, 8844736/R198, 8844737/R198
gastric dilatation, esophageal achalasia,
and dyspepsia
B The following symptoms of those patients 7870012/R11, 7871001/R12, 7885005/R34,
with nausea or heartburn and decreased 8830417/K297, 8844662/K318, 8844663/R198,
urine volume: Gastritis, gastric atony, and 8844736/R198, 8844737/R198
excessive fluid retention in the stomach
<- <-
Product Indica- Poria Sclero- Atracty- Atrac- Ginseng Ginger Citrus Imma-
JP> JP>
No. tions tium lodes Rhi- tylodes Unshiu ture Or-

zome Lancea Rhi- Peel ange

zome
1 A 5,0 4,0 3,0 0,8 3,0 1,5
2 B 5,0 4,0 3,0 1,0 3,0 1,5
A.2.2.6 Bukuryoingohangekobokuto
Indications Indications text Controlled identifiers
A The following symptoms of those pa- 8844688/R454, 7849002/F453, 3061005/F453,
tients who have depressed feelings and a 5309002/R198, 7851005/R002, 8841308/R42,
feeling of foreign body in the throat and 7870012/R11, 7871001/R12, 7885005/R34,
oesophagus and who sometimes have 3000010/F411, 3064021/F54, 3009007/F489,
palpitation, dizziness, nausea, heartburn, 8830417/K297, 6430002/O210, 8844663/R198,
and decreased urine volume: Anxiety 8844736/R198, 8844737/R198
neurosis, nervous gastritis, hyperemesis
gravidarum, water brash, and gastritis
<-
Product Indica- Poria Atrac- Gin- Ginger Citrus Imma- Pinellia Mag- Perilla
JP> <- <-
No. tions Sclero- tylodes seng Unshiu ture Or- Tuber nolia Herb
JP> JP>
tium Lancea Peel ange Bark
Rhi-
<-
zome
JP>
1 A 5,0 4,0 3,0 1,0 3,0 1,5 6,0 3,0 2,0
A.2.2.7 Bushirichuto
Indications Indications text Controlled identifiers
A The following symptoms of those patients with 8844662/K318, 7884011/R35,
gastrointestinal weakness, a bad complexion, a face 8839176/R688, 8833267/A09,
without vitality, high urine output, cold feeling in the 7870012/R11, 8841308/R42,
extremities, tendency to diarrhoea, frequent nausea, 7840022/R51, 8830562/R101,
dizziness, dull headache and stomachache: Chronic 5580033/K529
gastrointestinal catarrh and gastric atony
<- <-
Product Indications Ginseng Processed Aco- Processed Glycyrrhiza Atractylodes Rhi-
JP> JP>
No. nite Root Ginger zome
1 A 3,0 1,0 3,0 3,0 3,0
2 A 3,0 1,0 3,0 3,0 3,0
A.2.2.8 Byakkokaninjinto
Indications Indications text Controlled identifiers
A Thirst and hot flushes 8833352/R631, 8844828/R232
B The following symptoms of those patients with fre- 8833352/R631, 8844828/R232,
quent thirst for water or excessive hot feeling: Early 2500013/E14, 8844730/T678,
diabetes mellitus, sun stroke, and febrile disease 7806011/R509
<- <- <- <-
Product No. Indications Anemarrhena Rhi- Gypsum Glycyrrhiza Brown Rice Ginseng
JP> JP> JP> JP>
zome
1 B 5,0 15,0 2,0 8,0 3,0
2 A 5,0 15,0 2,0 8,0 1,5
3 A 5,0 15,0 2,0 8,0 3,0
14 © ISO 2018 – All rights reserved

A.2.2.9 Chikujountanto
Indications Indications text Controlled identifiers
A Patients with persisting fever during the convales- 4871001/J111, 4609023/J00,
cent phase of influenza, common cold, pneumonia, 4860030/J189, 7806011/R509,
etc. or those who do not feel refreshed after the 3000010/F411, 7862008/R05,
temperature has returned to normal and cannot 8831159/R093, 8839792/G470,
have a good sleep with frequent coughing or ex- 8844695/R198
pectoration
Prod- Indica- Bu- Bam- Poria Ophio- Citrus Imma- Coptis Glycyr- Pinel- Cype- Gin- Platy- Gin-
<- <- <-
uct tions pleu- boo Sclero- pogon Unshiu ture Rhi- rhiza lia rus ger codon seng
<- <- JP> JP> <- JP>
No. rum Cul- tium Tu- Peel Or- zome Tu- Rhi- Root
<- JP> <- JP> <- <- JP>
Root m ber ange ber zome
JP> JP> JP> JP>
1 A 3,0 3,0 3,0 3,0 2,0 2,0 1,0 1,0 5,0 2,0 1,0 2,0 1,0
A.2.2.10 Choijokito
Indications Indications text Controlled identifiers
A Constipation 8840042/K590

Product No. Indications Rhubarb Anhydrous Sodium Sulfate Glycyrrhiza
1 A 2,0 0,5 1,0
A.2.2.11 Choreito
Indications Indications text Controlled identifiers
A The relief of decreased urine volume, difficulty in 7885005/R34, 7881001/R391, 7880004/
micturition, and micturition pain or feeling of resid- R309, 7886003/R398
ual urine
B The following symptoms of those patients with 8833352/R631, 7880004/R309,
thirst, painful micturition, dysuria, red urine or 7881001/R391, 5997009/R31, 8833170/
blood in urine, oedema of lower back or legs: Ne- R31, 7823024/R609, 5839010/N059,
phritis, nephrosis, bladder catarrh, urethritis, and 5819004/N049, 5959015/N309,
dysuria due to renal/bladder calculus 5978015/N342, 8835588/N200,
8840130/N210
C Cystitis, especially of acute cystitis, nephritis, dry 5959015/N309, 5950005/N300,
mouth due to renal calculus or urethritis, increased 5839010/N059, 8835588/N200,
urinary frequency, and micturition pain 5978015/N342, 8833352/R631,
8839433/R35, 7880004/R309
D The following symptoms of those patients who com- 7885005/R34, 7881001/R391, 8833352/
plain of decreased urine volume, dysuria, and oral R631, 5978015/N342, 5839010/N059,
dryness: Urethritis, nephritis, renal calculus, blenn- 8835588/N200, 980013/A549, 7880004/
orrhagic inflammation, micturition pain, hematuria, R309, 8833170/R31, 7823024/R609,
oedema of the lower part of the body from the waist 7886003/R398, 8833267/A09
down, feeling of residual urine, and diarrhoea

Product Indications Polyporus Poria Sclero- Alumini- Alisma Donkey Gelatin

No. Sclerotium tium um Silicate Tuber Glue
Hydrate with
Silicon Diox-

ide
1 A 3,0 3,0 3,0 3,0 3,0
2 B 3,0 3,0 3,0 3,0 3,0
3 A 3,0 3,0 3,0 3,0 3,0
4 C 3,0 3,0 3,0 3,0 3,0
5 D 3,0 3,0 3,0 3,0 3,0
A.2.2.12 Choreitogoshimotsuto
Indications Indications text Controlled identifiers
A The following symptoms of those patients who have dry skin and 7881001/R391, 7880004/
a constitution with an unhealthy complexion without any gas- R309, 7886003/R398,
trointestinal disorder: Difficulty in micturition, micturition pain, 8839433/R35
feeling of residual urine, and frequent urination
Prod- Indica- Japanese Peony Cnidi- Reh- Poly- Poria Aluminium Alisma Donkey
<-
uct tions Angelica Root um Rhi- man- porus Sclero- Silicate Hydrate Tuber Glue
JP> <-
No. Root zome nia Sclero- tium with Silicon
JP> <-
Root tium Dioxide
JP>
1 A 3,0 3,0 3,0 3,0 3,0 3,0 3,0 3,0 3,0
A.2.2.13 Chotosan
Indications Indications Text Controlled identifiers
A Chronic headache with hypertension in those mid- 7840016/R51, 7840024/R51,
dle-aged or elderly 8833421/I10
Prod- Indica- Un- Citrus Pinel- Ophio- Poria Gin- Saposh- Chry- Glycyr- Gin- Gyp-
<- <- <-
uct No. tions caria Unshiu lia Tu- pogon Sclero- seng niko- san- rhiza ger sum
<- <- <- JP> JP> JP>
Hook Peel ber Tu- tium via the-
JP> JP> JP>
ber Root mum
...