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Could EU herbal monographs contribute to Malta's treatment armamentarium?

ABSTRACT

Ten years have passed since Directive 2004/24/EC regulating herbal medicinal products across the EU were published. The directive created the Committee on Herbal Medicinal Products within the European Medicines Agency whose remit includes the creation and publishing of official EU monographs on herbal medicinal products. These monographs include the official uses of the products and their evidence for efficacy and safety. To this effect, we are interested in analysing the potential impact herbal product EU monographs could have on the therapeutic treatment options available for prescribers in Malta. Therefore our aim was two-fold. First, to rationalise the spread of indications of the herbal substances listed in the community herbal monograph inventory and subsequently determine if these herbal substances could potentially contribute to the treatment options available in our local scenario (Malta). 128 EU monographs were analysed resulting in a total of 230 indications which subsequently codified into 42 unique ATC codes. The Malta Medicines List contains 1456 unique ATC codes. Comparative analysis of the Malta Medicines List revealed that the 21 therapeutic areas had 4 or less pharmaceutically used substances (5th level ATC codes) registered and therefore in our opinion are areas with limited therapeutic choice. The following 4 therapeutic areas, A05 bile and liver therapy, A13 tonics, A15 appetite stimulants and D03 preparations for treatment of wounds and ulcers, could potentially benefit from the registration of herbal medicinal products according to the EU herbal monographs. If such registration is effected the aforementioned areas would no longer be considered limited because more than 4 therapeutic choices would be available to prescribers. This study is the first study across the EU to analyse the potential impact of published EU herbal monographs on therapeutic coverage in an EU member state and confirms the notion that herbal products could potentially increase the treatment options available in areas where few medical products have been registered due to Malta's small market size.

Keywords:

EU herbal monographs

ATC classification system

Therapeutic coverage

Introduction

Directive 2004/24/EC (hereafter referred to as the "directive") has had an effect on the regulatory framework of herbal medicinal products across Europe. The directive sets a framework for the registration of "traditional herbal medicinal products" through a simplified registration procedure for these traditional-use products (The European Parliament and the Council of the European Union 2004a). To be placed on the market, in the European Union (EU), a medicinal product needs a marketing authorisation. To obtain a marketing authorisation an application consisting of a dossier supporting the medicinal product's quality, safety and efficacy needs to be submitted to regulatory authorities. The dossier can either be a full stand-alone dossier consisting of the results of studies (clinical and preclinical as well as quality) conducted by the prospective marketing authorisation holder usually for an "on patent" medicinal product (originator/innovator medicine) or a dossier consisting of a full package of quality documentation, but a reduced clinical and pre-clinical program which is usually the case for medicines outside their data exclusivity such as generics, well established use medicinal products, hybrid (mixed bibliographic applications) and biosimilar medicinal products and herbal medicinal products.

The aim of this EU directive was to enhance the protection of public health whilst promoting the free movement of traditional medicinal products in the EU (Routledge 2008) through harmonised procedures. This directive also established the Committee on Herbal Medicinal Products (HMPC) (The European Parliament and the Council of the European Union 2004a) whose aim is to aid in the harmonisation of procedures and provisions concerning herbal medicinal products in EU Member States whilst further integrating herbal medicinal products in the European regulatory framework. One of the activities of the HPMC is the preparation of Community herbal monographs, which comprise the scientific opinion of the HMPC on the safety and efficacy (1) data concerning a herbal substance and its preparations intended for medicinal use, based on the experience of use within the community. EU herbal monographs are intended to be used as reference material in herbal marketing-authorisation applications (both for well-established-use and traditional-use applications) (The European Parliament and the Council of the European Union 2004a).

The aim of this study was therefore to investigate the potential impact herbal product EU monographs could have on the therapeutic treatment options available for prescribers in Malta. Our objectives were two: (1) to rationalise the spread of indications of the herbal substances listed in the community herbal monograph inventory; (2) to determine if these herbal substances could potentially contribute to the treatment options available in our local scenario (Malta). To our knowledge, this study is the first study across the EU to analyse the potential impact of published EU herbal monographs on therapeutic coverage in an EU member state and lends support to the notion that herbal products could increase treatment options in areas where few medical products have been registered due to Malta's small market size.

Method

Data source and inclusion criteria

All the EU monographs published by the HPMC were retrieved from the European Medicines Agency website (European Medicines Agency 2014). The filter function on the website was used to retrieve herbal products for which a monograph was available. The inclusion criteria for a monograph to be used for analysis included those monographs with the following statuses "Draft published", "Assessment close to finalisation (pre-final)" and "Assessment finalised". A total of 128 Community herbal monographs were included in the analysis.

The final and draft EU monographs included were published between July 2006 to January 2014 and July 2011 to November 2013 respectively. All EU herbal monographs were analysed and relevant information was compiled using Excel (Microsoft, Redmond, WA).

Data extraction and association rationale

The following data was captured: The EU Document Reference number of the monograph; the date of HMPC adoption; the scientific name; the common name of herbal substance; the legal basis for registration (Traditional use/Well Established Use) and all listed indications. In addition, information on the herbal preparation and pharmaceutical form was also captured.

The Anatomical Therapeutic Chemical (ATC) classification system was used to classify the captured indications. The ATC system used is a pharmaceutical coding system that divides drugs into different groups according to the organ or system on which they act and their therapeutic and chemical characteristics. Each bottom-level ATC code stands for a pharmaceutically used substance, or a combination of substances, in a single indication or use. It is important to note that using this coding system one drug can have more than one ATC code (WHO Collaborating Centre for Drug Statistics Methodology 2014).

For clarity's sake readers should keep in mind the following principles behind the ATC classification system's structure. The 1st level is the anatomical area and is denoted by a single letter for example: A for "Alimentary tract and metabolism". The 2nd level is the therapeutic subgroup area and is denoted by two digits for example: A10 which corresponds to "Drugs used in diabetes". The 3rd level is the pharmacological subgroup and is denoted by a single letter for example A10B which corresponds to "Blood glucose lowering drugs excluding insulins". The 4th level is the chemical subgroup and is denoted by another single letter for example A10BA which corresponds to Biguanides. Finally the 5th level or bottom level corresponds to a chemical substance or combination of substances and is denoted by two digits (WHO Collaborating Centre for Drug Statistics Methodology 2014). The full code therefore consists of 6 characters (refer to Table 1).

All indications per herbal product within the EU monograph were then subsequently analysed in order to associate an ATC code. Where the active substance considered had a specific ATC code as was the case for some herbal substance having a "Well-Established Use" for example Senna code A06AB06, Cascara code A06AB07, Valerian code N05CM09, etc. as per ATC/DDD Index 2014 (WHO Collaborating Centre for Drug Statistics Methodology 2014) this association was straightforward.

However when there was no specified ATC code, the association between the active substance in question and a relevant ATC code was made based on the wording of the specified indication in the EU monograph.

For example we classified the Traditional-Use of Achillea millefolium L., herba (Yarrow) worded as "Traditional herbal medicinal product used in temporary loss of appetite" with an ATC code of A15: Appetite stimulant. We arrived to this classification rationalising both anatomical and therapeutic reasons to associate an ATC code. In this example, Achillea millefolium L, herba is used to treat a "temporary loss of appetite" therefore, this herbal product affects the alimentary system, further to that, its clinical effect is to promote appetite. Therefore the ATC classification A15: Appetite stimulant is a reasoned association. It must be kept in mind that the ATC codes assigned in this manuscript are for reasons of comparison only and not generally transferable.

Determining the therapeutic coverage of the community herbal monographs; creation of the "Herbal Monograph ATC database"

Once the association exercise was completed, a database of 3rd, 4th and 5th level ATC codes corresponding to each indication was developed. Since a number of herbal substances had similar indications the database contained duplicate entries. Duplicate ATC codes were then removed. To assess the therapeutic coverage, 2nd level ATC codes were used. All 2nd level duplicates were removed and a database of unique therapeutic areas was established.

Determining the therapeutic coverage in Malta of authorised medicinal products

The Malta Medicines List was used (Malta Medicines Authority 2014). The list includes all medicinal products authorised in Malta, through any possible regulatory procedure that is National Procedures [Regulation 4(1) and 4(2) of the Medicines (Marketing Authorisation) Regulations] (Malta Government 2007), European Procedures [Mutual Recognition (MR) and Decentralised (DC) Procedures] (The European Parliament and the Council of the European Union 2004b) and Centralised Procedure (The European Parliament and the Council of the European Union 2004c). The list also provides the ATC codes for each medicinal product. Utilising the 2nd level ATC code the Malta Medicines List was reduced to unique 2nd level ATC codes.

Data and statistical analysis

The raw data on ATC codes obtained from herbal monographs as well as from Malta Medicines List were imported in Access (Microsoft, Redmond, WA) so that SQL queries (refer to graphical abstract for the SQL coding) and analysis could be run on the dataset. A query was designed to highlight unmatched records comparing the therapeutic subgroup coverage of the Malta Medicines List and the Community herbal monograph inventory to the complete ATC classification list at the second level and also comparing the therapeutic subgroup coverage of the Community herbal monograph inventory with the coverage of the Malta Medicines List.

This query clearly showed the spread of products and any therapeutic gaps. Descriptive statistics were calculated using Excel (Microsoft, Redmond, WA).

Results

From the 128 EU monographs analysed, a total of 230 indications resulted which were subsequently codified into 230 ATC codes. Following the removal of duplicate ATC codes entries, 42 unique 3rd and 4th level ATC codes (chemical/pharmacological subdivisions) remained.

Fig. 1 depicts the number observations of therapeutic areas for the Malta Medicines List and Herbal Monograph ATC database when compared to the maximum possible number of therapeutic areas divided according to the 14 Anatomical Areas as per the ATC/DDD Index 2014 (WHO Collaborating Centre for Drug Statistics Methodology 2014).

The frequency of therapeutic areas subdivided according to the 14 Anatomical Areas for Herbal Monograph ATC database are in the following frequency sequence. Alimentary tract and metabolism (A) [9 out of 16 (56%)] > dermatologicals (D) [6 out of 11 (55%)] > genitourinary system and sex hormones (G) [2 out of 4 (50%)] > nervous system (N) [3 out of 7 (43%)] > cardiovascular system (C) [3 out of 9 (33%)] = respiratory system (R) [2 out of 6 (33%)] = musculoskeletal system (M) [2 out of 6 (33%)] = sensory organs (S) [1 out of 3 (33%)] > various (V) [0 out of 9] = anti-infectives for systemic use (J) [0 out of 6] = systemic hormonal preparations, excluding sex hormones and insulins (H) [0 out of 5] = blood and blood forming organs (B) [0 out of 5] = antineoplastic and immunomodulating agents (L) [0 out 4] = antiparasitic products, insecticides and repellents (P) [0 out of 3].

Analysis of the Malta Medicines List revealed that 16747 single units are authorised in Malta (a single unit refers to a unique authorisation number and the data also includes centralised marketing authorisations where an EU number is issued also per pack size), corresponding to 1456 unique ATC codes. The ATC codes of Malta Medicines List covered all 14 Anatomical areas however 2 therapeutic gaps were observed as compared to the ATC/DDD index 2014 (WHO Collaborating Centre for Drug Statistics Methodology 2014). The therapeutic areas not covered were "A14" corresponding to "Anabolic agents for systemic use" and "V20" corresponding to "Surgical dressings". Further analysis of the EU Herbal Monograph ATC database indicates that the two therapeutic gaps identified would not be resolved by registration of herbal medicinal products according to the EU herbal monographs, since there is no coverage for the "A14" and "V20" therapeutic areas within the EU Herbal Monograph ATC database (refer to Table 2).

In order to explore further where therapeutic coverage of authorised medicinal products on the Maltese market is lacking, we analysed the ATC codes within the Malta Medicines List and identified the therapeutic areas (i.e. 2nd level ATC codes) where less than 5 unique 5th level ATC codes (i.e. substances or a combination of substances, in a single indication) were authorised. The results are presented in Tables 3a and 3b. Therapeutic areas where less than 5 unique 5th level ATC codes are authorised are considered by the investigators as areas of limited therapeutic coverage. The results show that 21 therapeutic areas have limited therapeutic choices. A comparison of the therapeutic areas identified from the Malta Medicines List with limited options versus the therapeutic areas from the EU Herbal Monograph ATC database is presented in Table 3a. The results show that for therapeutic areas A05, A13, A15 and D03, registration of herbal substances according to EU Herbal Product Monographs would increase the therapeutic coverage such that more than 4, 5th level ATC codes (refer to Table 3b) would be available for use. In our opinion, the EU Herbal Product Monographs would contribute in increasing treatment choices available by at least ~19% of therapeutically limited areas in the Maltese Scenario.

Discussion

The data within the present study supports the notion that EU Herbal Product Monographs could have an impact especially in minor indications where limited therapeutic choices are available due to the limited registration of medicinal products (chemicals or biologicals) in small markets.

The data also indicates that herbal products could contribute to therapeutic areas traditionally associated with herbal products such as the alimentary tract and the skin, which is not entirely unexpected. The 4 therapeutic areas identified to potentially have the largest impact are A05, A13, AT 5 and D03.

Analysis of the EU Herbal Monograph ATC database shows that the areas with the absolute highest number of products were A03, R05 and G04 having 33, 31 and 25 herbal substances respectively. Yet, the potential impact on increasing the treatment choices is small due to high number of chemical/biological medicinal products already registered in these areas. Although there are examples of herbal medicinal products used in moderate disease (e.g. Hypericum perforatum L. (St Johns Wart) and motherwort), analysis of the indications complied within the EU Herbal Monograph ATC database shows that the EU community herbal monographs are intended for the treatment of minor ailments. The indications of herbal products which would significantly contribute in increasing treatment choices in therapeutically deficient areas are listed for convenience in Table 4.

Once a marketing authorisation is granted, (2) the marketing status of the product has to be specified. The marketing status assigned by the member state will determine if that medicinal product will subject to medical prescription or not and will therefore be sold over the counter (OTC). Readers should keep in mind that for a product to be authorised as an OTC, then the criteria qualified in Directive 2001/83/EC (The European Parliament and the Council of the European Union 2001) setting the standards for medicinal products subject to a prescription must not be met. Thus medicinal products shall NOT be subject to medical prescription where they:

--are NOT likely to present a danger either directly or indirectly, even when used incorrectly, if utilised without medical supervision, or

--are NOT frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or

--do NOT contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or

--are NOT prescribed by a doctor to be administered parenterally.

In our opinion, even though EU community herbal monographs are aimed at treating minor ailments, this does not by default extend to the classification of a herbal medicinal product as OTC. When considering such classifications, regulators face the challenge of evaluating the subtle complexities of possible underlying pathophysiological conditions that need to be ruled out at the diagnosis stage, so that a herbal medicinal product is classified as OTC. For example, the monograph Cucurbita pepo L, semen (Pumpkin seed) has an indication of "Traditional herbal product for the relief of lower urinary tract symptoms related to benign prostatic hyperplasia or related to an overactive bladder, after serious conditions have been excluded by a medical doctor". Thus, this product could be classified as OTC as the indication is relatively minor once the diagnosis of benign prostatic hyperplasia has been made by the medical practitioner.

Conclusion

This study is the first study across the EU to analyse the potential impact of published EU herbal monographs on therapeutic coverage in an EU member state and confirms the notion that herbal products could potentially increase the treatment options available in areas where few medicinal products have been registered due to Malta's small market size. A limitation of this study was that we have not studied how the identified herbal medicinal products could be used. However, in Malta's scenario, it is clinically reasonable to first use all the drugs listed on the Malta Medicines List for a particular therapeutic area before evaluating herbal medicinal products. For the sake of clarity, it should be kept in mind that the results obtained in this study focussing on the number of treatment options for a given area rather than addressing areas of unmet medical need.

ARTICLE INFO

Article history: Received 24 September 2014

Revised 15 December 2014

Accepted 2 January 2015

Conflict of interest

The authors declare no direct or indirect potential conflicts of interest.

Disclaimer

The views expressed in this article are the personal views of the authors and may not be used or quoted as being made on behalf of, or reflecting the position of, any national competent authority, the EMA or one of its committees or working parties or any University.

References

European Medicines Agency, 2014. Herbal Medicines for Human Use Online Database.

Malta Government, 2007. Subsidiary Legislation 458.34, Laws of Malta. Legal Notice 324 of 2007. Medicines (Marketing Authorisation) Regulations, 2007. Government Gazette of Malta 18139.

Malta Medicines Authority, 2014. Malta Medicines List.

Routledge, P.A., 2008. The European Herbal Medicines Directive: could it have saved the lives of Romeo and Juliet? Drug Saf. 31, 416-418.

The European Parliament and the Council of the European Union, 2001. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Off. J. Eur. Commun. 67-128.

The European Parliament and the Council of the European Union, 2004a. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Off. J. Eur. Commun. L136, 85-90.

The European Parliament and the Council of the European Union, 2004b. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Off. J. Eur. Commun. L136, 34-57.

The European Parliament and the Council of the European Union, 2004c. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off. J. Eur. Commun. 1-33.

WHO Collaborating Centre for Drug Statistics Methodology, 2014. Norwegian Institute of Public Health "ATC/DDD Index." Oslo, Norway. http://www.whocc.no/atc_ddd_index/.

(1) Although the HPMC review the efficacy of an herbal medicinal product, it must be qualified that the robustness and amount of evidence based data to prove efficacy for a traditional herbal product is less than that for a new compound, which in turn explains why the claims of a traditional herbal product are restricted. The efficacy of a herbal medicinal product and a standard drug should not be treated as equivalent unless the herbal medicinal product has undergone the same clinical development path as a standard drug with randomised Clinical Trials.

(2) To be placed on the market, in the European Union (EU), a medicinal product needs a marketing authorisation. To obtain a marketing authorisation an application consisting of a dossier supporting the medicinal product's quality, safety and efficacy needs to be submitted to regulatory authorities. The dossier can either be a full standalone dossier consisting of the results of studies (clinical and preclinical as well as quality) conducted by the prospective marketing authorisation holder usually for an "on patent" medicinal product (originator/innovator medicine) or a dossier consisting of a full package of quality documentation, but a reduced clinical and pre-clinical program which is usually the case for medicines outside their data exclusivity such as generics, well established use medicinal products, hybrid (mixed bibliographic applications) and biosimilar medicinal products and herbal medicinal products.

B. Micallef (a), E. Attard (b), A. Serracino-Inglott (a,c), J.J. Borga (a,d), *

(a) Medicines Authority, 203 Level 3, RueD'Argens, Gzira, GZR 1368, Malta

(b) Institute of Earth Systems, University of Malta, Malta

(c) Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta

(d) Department of Biology, School of Pharmacy, University of Tor Vergata, Rome, Italy

* Corresponding author at: Medicines Authority, 203 Level 3. Rue D'Argens, Gzira, GZR 1368. Malta. Tel.: +356 23439129; fax: +356 23439161.

E-mail address: john-joseph.borg@gov.mt (J.J. Borg).

http://dx.doi.org/10.1016/j.phymed.2015.01.005

Table 1
The structure of the coding system as illustrated by the complete
classification of metformin.

Code      Description              Level description

A         Alimentary tract and     1st level--Anatomical main group
            metabolism
A10       Drugs used in diabetes   2nd level--Therapeutic subgroup
A10B      Blood glucose lowering   3rd level--Pharmacological subgroup
            drugs, exd. Insulins
A10BA     Biguanides               4th level--Chemical subgroup
A10BA02   Metformin                5th level--Chemical substance

Adapted from WHO Collaborating Centre for Drug Statistics Methodology
(2014).

Table 2
Comparison of analysis of 2nd level ATC codes (therapeutic areas) for
the ATC/DDD Index 2014 (WHO Collaborating Centre for Drug Statistics
Methodology 2014), the Malta Medicines List and EU Herbal Monograph
ATC database.

Full list ATC   MML           Herbals
second level    second        second level
codes           level codes   codes

A01             A01           A01
A02             A02
A03             A03           A03
A04             A04           A04
A05             A05           A05
A06             A06           A06
A07             A07           A07
A08             A08           A08
A09             A09
A10             A10
A11             A11
A12             A12
A13             A13           A13
A14
A15             A15           A15
A16             A16
B01             B01
B02             B02
B03             B03
B04             B04
B05             B05
B06             B06
C01             C01           C01
C02             C02
C03             C03           C03

Full list ATC   MML           Herbals
second level    second level  second level
codes           codes         codes

C04             C04
C05             C05           C05
C06             C06
C07             C07
C08             C08
C09             C09
C10             C10
D01             D01           D01
D02             D02           D02
D03             D03           D03
D04             D04           D04
D05             D05
D06             D06
D07             D07
D08             D08
D09             D09
D10             D10           D10
D10             D10           D11
G01             G01
G02             G02           G02
G03             G03
G04             G04           G04
H10             H10
H02             H02
H03             H03

Full list ATC   MML           Herbals
second level    second        second level
codes           level codes   codes

H04             H04
H05             H05
J01             J01
J02             J02
J03             J03
J04             J04
J05             J05
J06             J06
J07             J07
L10             L10
L02             L02
L03             L03
L04             L04
M10             M10           M10
M02             M02           M02
M03             M03
M04             M04
M05             M05
M09             M09
N10             N10
N02             N02           N02
N03             N03
N04             N04
N05             N05           N05
N06             N06           N06

Full list AT    MML           Herbals
second level    second        second level
codes           level codes   codes

N07             N07
P01             P01
P02             P02
P03             P03
R01             R01
R02             R02           R02
R03             R03
R04             R04
R05             R05           R05
R06             R06
R07             R07
S10             S10           S10
S02             S02
S03             S03
V01             V01
V02             V02
V03             V03
V04             V04
V05             V05
V06             V06
V07             V07
V08             V08
V09             V09
V10             V10
V20

The first column shows all possible 2nd level ATC codes, derived from
the ATC/DDD index 2014 (WHO Collaborating Centre for Drug Statistics
Methodology 2014), and is used a standard reference to compare the
therapeutic coverage of the Malta Medicines List and EU Herbal
Monograph ATC database respectively. This figure also compares the
therapeutic coverage of the EU Herbal Monograph ATC database to that
of the Malta Medicines List.

Table 3a
Comparison of the number of unique chemicals substance authorised
(5th level ATC codes) within a therapeutic area (2nd level ATC
division) identified from the Malta Medicines List with the
corresponding number of herbs from EU Herbal Monograph ATC database.

Code   Description

A05    Bile and liver therapy
A08    Antiobesity preparations, excluding diet products
A09    Digestives, including enzymes
A13    Tonics
A14    Anabolic agents for systemic use
A15    Appetite stimulants
B06    Other haematological agents
C04    Peripheral vasodilators
D03    Preparations for treatment of wounds and ulcers
D05    Antipsoriatics
D09    Medicated dressings
H04    Pancreatic hormones
M04    Antigout preparations
M09    Other drugs for disorders of the musculo-skeletal
         system
P02    Anthelmintics
P03    Ectoparasiticides including scabicldes, insecticides
         and repellents
S03    Ophthalmological and otological preparations
V01    Allergens
V06    General nutrients
V07    All other non-therapeutic products
V20    Surgical dressings

Code   Malta            Herbal Monograph   Combined
       Medicines List   ATC database

A05    4                 2                  6
A08    1                 1                  2
A09    1                 0                  1
A13    1                 6                  7
A14    0                 0                  0
A15    1                10                 11
B06    3                 0                  3
C04    3                 0                  3
D03    1                 5                  6
D05    4                 0                  4
D09    1                 0                  1
H04    1                 0                  1
M04    4                 0                  4
M09    4                 0                  4
P02    1                 0                  1
P03    4                 0                  4
S03    1                 0                  1
V01    1                 0                  1
V06    1                 0                  1
V07    1                 0                  1
V20    0                 0                  0

Table 3b
Highlight of therapeutic areas which could potentially benefit from
the registration of herbal medicinal products according to the EU
herbal monographs.

Code   Description                  Malta       Herbal         Combined
                                    Medicines   Monograph
                                    List        ATC database

A05    Bile and liver therapy       4            2              6
A13    Tonics                       1            6              7
A15    Appetite stimulants          1           10             11
D03    Preparations for treatment   1            5              6
         of wounds and ulcers

Table 4
List of indications of herbal substances/preparations contributing to
treatment choices.

Scientific name                      Plant part

Therapeutic area: A15
  Achillea millefolium L., flos      Dried inflorescence
  Achillea millefolium L., herba     Not applicable
  Arctium lappa L., radix            Not applicable
  Artemisia absinthium L., herba     Not applicable
  Centaurium Erythraea Rafn,         Not applicable
    herba
  Cichorium intybus L., radix        Not applicable
  Harpagophytum Procumbens DC        Cut dried tuberous
    and/or Harpagophytum Zeyheri       secondary root
    Decne, radix
  Marrubium vulgare L., herba        Not applicable
  Trigonella foenum-graecum L.,      As defined in the Ph.
    semen                              Eur. Monograph

Therapeutic area: A13
  Camellia sinensis (L.,) Kuntze,    Whole dried leaf
    non fermentatum folium
  Cola nitida (Vent.) Schott et      Not applicable
    Endl. and its varieties and
    Cola acuminata (P. Beauv.)
    Schott et Endl., semen
  Eleutherococcus Senticosus         Not applicable
    (Rupr. Et Maxim.) Maxim.,
    radix
  Ilex paraguariensis St.            Not applicable
    Hilaire, folium
  Paullinia cupana Kunth ex          Not applicable
    H.B.K. var. sorbilis (Mart.)
    Ducke, semen

Therapeutic area: A05
  Curcuma Longa L., rhizoma          Not applicable
  Fumaria officinalis L., herba      Not applicable

Therapeutic area: D03
  Achillea millefolium L., flos      The dried inflorescence
  Achillea millefolium L., herba     Not applicable
  Commiphora molmol Engler,          Not applicable
    gummi-resina
  Echinacea purpurea (L.,)           Not applicable
    Moench, radix
  Melaleuca alternifolia (Maiden     Not applicable
    and Betch) Cheel, M.
    linariifolia Smith, M.
    dissitiflora F. Mueller
    and/or other species of
    Melaleuca, aetheroleum

Scientific name                      English name

Therapeutic area: A15
  Achillea millefolium L., flos      Yarrow flower
  Achillea millefolium L., herba     Yarrow
  Arctium lappa L., radix            Burdock root
  Artemisia absinthium L., herba     Wormwood herb
  Centaurium Erythraea Rafn,         Centaury herb
    herba
  Cichorium intybus L., radix        Chicory root
  Harpagophytum Procumbens DC        Devil's claw root
    and/or Harpagophytum Zeyheri
    Decne, radix
  Marrubium vulgare L., herba        White horehound
  Trigonella foenum-graecum L.,      Fenugreek
    semen

Therapeutic area: A13
  Camellia sinensis (L.,) Kuntze,    Green tea leaf
    non fermentatum folium
  Cola nitida (Vent.) Schott et      Cola
    Endl. and its varieties and
    Cola acuminata (P. Beauv.)
    Schott et Endl., semen
  Eleutherococcus Senticosus         Eleutherococcus root
    (Rupr. Et Maxim.) Maxim.,
    radix
  Ilex paraguariensis St.            Mate Leaf
    Hilaire, folium
  Paullinia cupana Kunth ex          Guarana seed
    H.B.K. var. sorbilis (Mart.)
    Ducke, semen

Therapeutic area: A05
  Curcuma Longa L., rhizoma          Turmeric root
  Fumaria officinalis L., herba      Fumitory

Therapeutic area: D03
  Achillea millefolium L., flos      Yarrow flower
  Achillea millefolium L., herba     Yarrow
  Commiphora molmol Engler,          Myrrh
    gummi-resina
  Echinacea purpurea (L.,)           Purple coneflower root
    Moench, radix
  Melaleuca alternifolia (Maiden     Tea tree oil
    and Betch) Cheel, M.
    linariifolia Smith, M.
    dissitiflora F. Mueller
    and/or other species of
    Melaleuca, aetheroleum

Scientific name                      Indication as worded in EU
                                     Official herbal monograph

Therapeutic area: A15
  Achillea millefolium L., flos      Traditional herbal medicinal
                                       product used for temporary loss
                                       of appetite
  Achillea millefolium L., herba     Traditional herbal medicinal
                                       product used for temporary loss
                                       of appetite
  Arctium lappa L., radix            Traditional herbal medicinal
                                       product used for temporary loss
                                       of appetite
  Artemisia absinthium L., herba     Traditional herbal medicinal
                                       product used for temporary loss
                                       of appetite
  Centaurium Erythraea Rafn,         Traditional herbal medicinal
    herba                              product used for temporary loss
                                       of appetite
  Cichorium intybus L., radix        Traditional herbal medicinal
                                       product used for temporary loss
                                       of appetite
  Harpagophytum Procumbens DC        Traditional herbal medicinal
    and/or Harpagophytum Zeyheri       product used for temporary loss
    Decne, radix                       of appetite
  Marrubium vulgare L., herba        Traditional herbal medicinal
                                       product used for temporary loss
                                       of appetite
  Trigonella foenum-graecum L.,      Traditional herbal medicinal
    semen                              product used for temporary loss
                                       of appetite

Therapeutic area: A13
  Camellia sinensis (L.,) Kuntze,    Traditional herbal medicinal
    non fermentatum folium             product for relief of fatigue
                                       and sensation of weakness
  Cola nitida (Vent.) Schott et      Traditional herbal medicinal
    Endl. and its varieties and        product for symptoms of
    Cola acuminata (P. Beauv.)         fatigue and sensation of
    Schott et Endl., semen             weakness
  Eleutherococcus Senticosus         Traditional herbal medicinal
    (Rupr. Et Maxim.) Maxim.,          product for symptoms of asthenia
    radix                              such as fatigue and weakness
  Ilex paraguariensis St.            Traditional herbal medicinal
    Hilaire, folium                    product for symptoms of fatigue
                                       and sensation of weakness
  Paullinia cupana Kunth ex          Traditional herbal medicinal
    H.B.K. var. sorbilis (Mart.)       product for symptoms of fatigue
    Ducke, semen                       and sensation of weakness

Therapeutic area: A05
  Curcuma Longa L., rhizoma          Traditional herbal medicinal
                                       product used to increase bile
                                       flow for the relief of symptoms
                                       of indigestion (such as
                                       sensation of fullness,
                                       flatulence, and slow digestion)
  Fumaria officinalis L., herba      Traditional herbal medicinal
                                       product used to increase bile
                                       flow for the relief of symptoms
                                       of indigestion (such as
                                       sensation of fullness,
                                       flatulence and slow digestion)
Therapeutic area: D03
  Achillea millefolium L., flos      Traditional herbal medicinal
                                       product for the treatment of
                                       small superficial wounds
  Achillea millefolium L., herba     Traditional herbal medicinal
                                       product for the treatment of
                                       small superficial wounds
  Commiphora molmol Engler,          Traditional herbal medicinal
    gummi-resina                       product for treatment of minor
                                       wounds and small boils
                                       (furuncles)
  Echinacea purpurea (L.,)           Traditional herbal medicinal
    Moench, radix                      product for treatment of small
                                       superficial wounds
  Melaleuca alternifolia (Maiden     Traditional herbal medicinal
    and Betch) Cheel, M.               product for treatment of small
    linariifolia Smith, M.             superficial wounds and insect
    dissitiflora F. Mueller            bites
    and/or other species of
    Melaleuca, aetheroleum
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Article Details
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Author:Micallef, B.; Attard, E.; Serracino-Inglott, A.; Borg, J.J.
Publication:Phytomedicine: International Journal of Phytotherapy & Phytopharmacology
Article Type:Report
Geographic Code:4EXML
Date:Mar 15, 2015
Words:5350
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