List of Terms used in Homeopathy

HOMEOPATHIC MEDICINAL PRODUCTS WORKING GROUP – for adoption for release for consultation

HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG)

FOR RELEASE FOR PUBLIC CONSULTATION

LIST OF TERMS USED IN HOMEOPATHY Related to homeopathic medicinal products

Initial submission of the document in the HMPWG

29 April 2009

First discussion in the HMPWG

8-9 December 2009

Second discussion in the HMPWG

7-8 December 2011

Third discussion (New Draft) in the HMPWG

6 June 2012

Fourth discussion (after written comments) in the HMPWG

23 October 2012

Adoption by the HMPWG

23 October 2012

Revision after comments CMD-v Transmission to HMA for release for public consultation:

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7 March 2013 4 April 2013


Introduction: Following the mandate of the Homeopathic Medicinal Products Working Group (HMPWG), the group shall be a forum for exchange of regulatory and scientific expertise regarding the assessment of the quality and safety of homeopathic medicinal products for human and veterinary use in the Member States, and provide guidance on the assessment of homeopathic medicinal products by Competent Authorities. For reasons of harmonization, a list of terms used in homeopathy is drafted, which shall be published. Terms are presented in alphabetical order in English, and supplementary, in other European languages. Translations of terms have no legal standing. Inclusion of terms specific to homeopathy and homeopathic therapy is not a result of any scientific evaluation, or endorsement, but is exclusively based on the homeopathic therapy as it is traditionally used in Member States. When definitions are based on European legislation or the European Pharmacopoeia or national pharmacopoeias officially used in Member States, only the reference is given. For terms without official reference in European legislation or in the European Pharmacopoeia, a description is presented based on a harmonized view in the HMPWG. ___________________________________________________________________________ Centesimal dilution / Centesimal potencies: Symbol: D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

C, CH

C-Potenzen, Centesimalverdünnung Dilutions Centésimale(s) (C) , Dilutions Centésimale(s) Hahnemannienne(s) (CH) Diluciones centesimales Diluizioni centesimali Centesimale verdunning C-potenssit, Sentesimaalilaimennokset Diluição centisimal Rozcieńczenie setne Centesimāls(ie) atšķaidījums(i) (C potence(es)) Centezimális hígítás/centezimális potenciák

Definition according to European Pharmacopoeia, monograph 1038 Homeopathic Preparations ___________________________________________________________________________ Classical homeopathy Synonyms :Unitarian homeopathy In France: Unicism D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Klassische Homöopathie Homéopathie uniciste Homeopatía unicista Omeopatia unicista Klassieke homeopathie Klassinen homeopatia Homeopatia Unicista Homeopatia klasyczna Klasiskā homeopātija Klasszikus homeopátia

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Method of homeopathic practice using a single homeopathic medicinal product, (homeopathic preparation derived from stock/raw material according to a homeopathic manufacturing method) and usually administered to a patient purely based on the Similia principle. No official reference for definition ___________________________________________________________________________ Clinical homeopathy: In France: Pluralism D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Klinische Homöopathie Homéopathie pluraliste Homeopatía clínica Omeopatia pluralista Klinische homeopathie Kliininen homeopatia Homeopatia pluralista Homeopatia kliniczna Klīniskā homeopātija Klinikai homeopátia

Method of homeopathic practice using different homeopathic medicinal products, prescribed on the clinically most prominent symptoms, complaints, or disease, based on the Similia principle. No official reference for definition ___________________________________________________________________________ Complex homeopathy: D: Fr: Es: It: NL: FIN:

Komplexhomöopathie Homéopathie complexiste Homeopatía complejista Omeopatia complessista Complex-homeopathie Homeopaattinen yhdistelmähoito

Por:

Homeopatia complexista

Pl: LV: HU :

Homeopatia kompleksowa Kompleksā homeopātija Komplex homeopátia

Method of homeopathic treatment using more than one homeopathic preparation combined in a single homeopathic medicine, usually taken more than once daily. Usually taken on the basis of a pre-defined indication. No official reference for definition ___________________________________________________________________________ Decimal dilution / decimal potencies: Symbol: D: Fr: Es:

D, DH, X

D-Potenzen, Dezimalverdünnung Dilutions décimales Hahnemanniennes DH Diluciones decimales

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It: NL : FIN : Por: Pl: LV: HU:

Diluizioni decimali Decimale verdunning D-potenssit, Desimaalilaimennokset Diluição decimal Rozcieńczenie dziesiętne Decimāls(ie) atšķaidījums(i) (D potence(es)) Decimális hígítás/decimális potenciák

Definition according to European Pharmacopoeia, monograph 1038 Homeopathic Preparations ___________________________________________________________________________ DOSAGE FORMS: A dosage form of a homeopathic preparation complies with any relevant dosage form monograph in the European Pharmacopoeia, and with the following: - for the purpose of dosage forms for homeopathic use, “active substances” are considered to be dilutions or triturations of homeopathic stocks or the stocks themselves. - these dosage forms are prepared using appropriate excipients - a test for uniformity of content or uniformity of dosage units can be required. Cream: For official translations reference is made to Standard Terms1 Definition according to European Pharmacopoeia, monograph 0132 Semi-solid preparations for

cutaneous application, and to Standard Terms Gel:

For official translations reference is made to Standard Terms Definition according to European Pharmacopoeia, monograph 0132 Semi-solid preparations for cutaneous application, and to Standard Terms Ointment: For official translations reference is made to Standard Terms Definition according to European Pharmacopoeia, monograph 0132 Semi-solid preparations for

cutaneous application, and to Standard Terms Oral drops, solution:

In Germany also: Mischung; Flüssige Verdünnung, Lösung For official translations reference is made to Standard Terms. Definition according to European Pharmacopoeia, monograph 0672 Liquid preparations for oral use and to Standard Terms

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Standard Terms for dosage forms, routes of administration and containers (ISBN 92‐871‐5734‐0)

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Oromucosal preparations: For official translations reference is made to Standard Terms Definition according to European Pharmacopoeia, monograph 1807 Oromucosal preparations and to Standard Terms Oral Powder: In Germany also:

Verreibung, Mischung aus Verreibungen

For official translations reference is made to Standard Terms Definition according to European Pharmacopoeia, monograph 1165 Powders, oral and to Standard Terms Pillules for homeopathic use In In In In In In In In In In

Germany: France: Belgium: France: Spain: Finland Netherlands: Poland: Latvia: Hungary:

Streukügelchen (Globuli) und Globuli velati granules , granules en récipient unidose granules, globules, microglobules (depending of the size) granules en recipient unidose Glóbulos Helmet homeopaattiseen käyttöön Homeopathische korrels, granules, globuli, microglobuli Granulki Homeopātiskie graudiņi Homeopátiás golyócskák

For official translations reference is made to Standard Terms Definitions according to European Pharmacopoeia: Monograph 1038

Homeopathic preparations

Monograph 2079

Homeopathic pillules, impregnated

Monograph 2153

Pillules for homeopathic preparations

Monograph 2786

Homeopathic pillules, coated

Tablets: For official translations reference is made to Standard Terms Definition according to European Pharmacopoeia monograph 1038 Homeopathic preparations, European Pharmacopoeia monograph 0478 Tablets, and to Standard Terms. ___________________________________________________________________________

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Gemmotherapy: D: Fr: It: NL:

Gemmotherapie Gemmothérapie Gemmoterapia Gemmotherapie

FIN: Por:

Gemmoterapia Gemoterapia

Pl: LV: HU.

Gemmoterapia Gemmoterapija Gemmoterápia

This therapy uses glycerol macerates prepared from embryonic plant tissue (buds) of a defined range of plants, harvested at a time when this is in the process of incipient growth. Remedies are prescribed in low potencies (D1) according to clinical indication, traditionally used mainly in France and Belgium No official reference for definition ___________________________________________________________________________ Glycerol macerates: D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Glycerolmazerat Macérat glycériné Macerado glicerinado Macerati glicerici Glycerinemaceraat Glyserolimaseraatti Macerado glicerinado Maceraty glicerolowe Glicerīna macerāti Glicerines macerátumok

Definition according to European Pharmacopoeia, monograph 1038 Homeopathic Preparations ___________________________________________________________________________ Herbal drugs for homeopathic preparations D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Pflanzliche Drogen für homöopathische Zubereitungen Drogues végétales pour préparations homéopathiques Drogas vegetales para preparaciones homeopáticas Droghe vegetali per preparazioni omeopatiche Botanische bestanddelen voor homeopathische bereiding Kasviperäiset aineet homeopaattisia tuotteita varten Fármacos vegetais para preparações homeopáticas Substancje roślinne do preparatów homeopatycznych Augu valsts drogas homeopātiskajiem pagatavojumiem Növényi drogok homeopátiás készítményekhez

Definitions according to European Pharmacopoeia, monograph 2045 Herbal drugs for

homeopathic preparations

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Homeopathic aggravation: D: AUS: Fr: Bel Es: It: NL: FIN: Por: Pl: LV: HU:

Erstverschlimmerung Erstreaktion Aggravation des symptômes aggravation homeopathique Agravamiento homeopático Aggravamento omeopatico Beginverergering Aggravaatio homeopatiassa Agravamento homeopático Pogorszenie pierwotne Sākotnējā stāvokļa pasliktināšanās Homeopátiás rosszabbodás

According to homeopathic theory, a temporary worsening of symptoms of a patient in response to a homeopathic medicine. Not to be considered as an adverse effect, for which the definition is “a response to a medicinal product which is noxious and unintended.” (according to Directive 2010/84/EC). In veterinary medicine, not to be considered as an adverse reaction, for which the definition is “a reaction to a veterinary medicinal product which is harmful and unintended and which occurs at doses normally used” (according to Directive 2001/82 EC as amended). No official reference for definition ___________________________________________________________________________ Homeopathic Drug Picture : D: Fr: Es: It: NL:

Arzneimittelbild Pathogénésie Patogenésia Patogenesi Geneesmiddelbeeld

FIN: Por:

Homeopaattinen lääkekuva Patogenesia

Pl: LV: HU:

Obraz leku Patogenitāte Homeopátiás gyógyszerkép

All of the symptoms, signs and complaints for a homeopathic remedy after the administration of doses of the substance, the mother-tincture or the homeopathic potency, from which the homeopathic profile can be derived. No official reference for definition ___________________________________________________________________________ Homeopathic medicinal product: D: Fr: Es: It: NL:

Homöopathisches Arzneimittel Médicament homéopathique Medicamento homeopático Medicinale omeopatico Homeopathisch geneesmiddel

FIN:

Homeopaattinen valmiste

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Por:

Medicamento homeopático

Pl: LV: HU:

Homeopatyczny produkt leczniczy Homeopātiskās zāles Homeopátiás gyógyszer

Definition according to article 1 of Directive 2001/83/EC, as amended ___________________________________________________________________________ Homeopathic veterinary medicinal product: D: Fr: Bel: NL: FIN: Por: Pl: LV: HU:

Homöopathisches Tierarzneimittel Médicament homéopathique vétérinaire Médicament homéopathique à usage vétérinaire / Homeopathische geneesmiddelen voor diergeneeskundig gebruik Homeopathisch diergeneesmiddel Homeopaattinen valmiste eläimille Medicamento homeopático para uso veterinário Produkt leczniczy homeopatyczny weterynaryjny Homeopātiskās veterinārās zāles Homeopátiás állatgyógyszer

Definition according to article 1 of Directive 2001/82/EC as amended. ___________________________________________________________________________ Anthroposophic medicinal products to be treated as homeopathic medicinal products D: Fr: Bel : It: NL : FIN: Por: Pl: LV: HU:

Homöopathisches Arzneimittel der anthroposophischen Therapierichtung Médicament homéopathique traditionnellement utilisé en Anthroposophie Médicaments anthroposophiques préparés selon des méthodes homéopathiques/ Antroposofische geneesmiddelen gefabriceerd volgens homeopathische methoden Medicinale omeopatico utilizzato in antroposofia Homeopathisch geneesmiddel toegepast op basis van de principes van de antroposofische geneeswijze. Antroposofiset valmisteet, jotka käsitellään homeopaattisina valmisteina Medicamento homeopático Antropozoficzne produkty lecznicze traktowane jako homeopatyczne produkty lecznicze Antropozofiskā lietojuma homeopātiskās zāles Homeopátiás gyógyszerként kezelt antropozófiás gyógyszer

Under “Recital 22” preceding Directive 2001/83/EC, as amended, it is stated that anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method are to be treated, as regards registration and marketing authorization, in the same way as homeopathic medicinal products. ___________________________________________________________________________ Homeopathic preparation: D: Fr: Es: It: NL:

Homöopathische Zubereitung Préparation homeopathique Preparación homeopática Preparazione omeopatica Homeopathische bereiding

FIN: Por:

Homeopaattinen tuote Preparação homeopática

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Pl: LV HU:

Preparat homeopatyczny Homeopātiskais zāļu pagatavojums Homeopátiás készítmény

Definition according to European Pharmacopoeia monograph 1038 Homeopathic preparations ___________________________________________________________________________ Homeopathic Proving: D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Homöopathische Arzneimittelprüfung Pathogénésie Patogenésia Proving Geneesmiddelenproef Homeopaattinen testaus Patogenesia Homeopatyczna próba lekowa Zāļu homeopātiskā pārbaude Homeopátiás gyógyszervizsgálat

Method used in homeopathy by which the profile of a homeopathic medicine is determined by the administration of doses of the substance, the mother-tincture or the homeopathic potency to healthy volunteers that can elicit symptoms from which the homeopathic profile can be derived. No official reference for definition ___________________________________________________________________________ Homeopathic Repertory: D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Repertorium Répertoire homéopathique Repertorio homeopático Repertorio omeopatico Repertorium Homeopaattinen repertuaari Repertório homeopático Repertorium Homeopātiskais repetorijs Homeopátiás repertórium

A homeopathic repertory is an extensive and comprehensive index of symptoms and their corresponding remedies, including systematic cross reference of symptoms and disorders related to the homeopathic remedy in whose therapeutic repertoire they occur. No official reference for definition ___________________________________________________________________________ Homeopathic stock: D: Fr: Es: It:

Konzentrierte Zubereitung Souche / souche homéopathique Cepa homeopática Materiale di partenza per preparazioni omeopatiche/ceppo omeopatico

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NL: BEL: FIN: Por: Pl: LV: HU:

Homeopathische grondstof NL:Stamproduct Bel: Fr souche Homeopaattinen kanta-aine Stock homeopático Homeopatyczny preparat wyjściowy Homeopātiskā izejviela Homeopátiás kiindulási anyag

Definition according to European Pharmacopoeia, monograph 1038 Homeopathic preparations ___________________________________________________________________________ Homeopathy: Homeopathy is a therapeutic system based on the Similia-principle. It was founded by Samuel Hahnemann (1755-1843). He published his theory of homeopathy in the “Organon of the Healing Art”. No official reference for definition ___________________________________________________________________________ K-potencies D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Korsakoff-Potenzen Dilutions Korsakoviennes Diluciones korsakovianas Diliuzioni Korsakoviane Korsakov potenties Korsakovin laimennokset Diluíções Korsakovianas Rozcieńczenie Korsakova Korsakova atšķaidījumi (K potences) K potenciák

Homeopathic preparations that have been prepared using the so-called Korsakov method: In the process of serial dilution/potentisation only one container is used throughout the process. Each dilution factor corresponds to a ratio 1:100. 30 K 200 K MK 10M K (XMK) 50M K (LMK) CMK

30 times 1:100 one glass method 200 times 1:100 one glass method 1000 times 1:100 one glass method 10,000 times 1:100 one glass method 50,000 times 1:100 one glass method 100.000 times 1:100 one glass method

No official reference for definition ___________________________________________________________________________ LM – potencies: Symbol: LM D: Fr: Es:

LM-Potenzen Dilutions LM Diluciones cincuentamilesimales

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It: NL: Bel: Bel: FIN: Por: Pl: LV: HU

Diluizioni LM/cinquantamillesimali LM-potenties Cinquante millésimales/LM dilutions vijftig millesimalen/ LM verdunningen LM- potenssit Diluíções LM Potencje LM LM atšķaidījumi (LM potences) LM potenciák

Definition according to European Pharmacopoeia, monograph 1038 Homeopathic preparations ___________________________________________________________________________ Materia medica: D: Fr: Es : It: NL : FIN: Por: Pl: LV: HU:

Materia Medica Matière médicale Materia Médica Materia medica Materia medica Materia medica Matéria médica Materia Medica Materia Medica Materia medica

The term Materia Medica is used to reference the total sum of homeopathic medicines, their corresponding symptom-profile and conditions for which they may be used. In homeopathy, Materia medica are often named after the author: Materia medica of Boericke, Materia medica of Voisin etc. No official reference for definition ___________________________________________________________________________ Methods of preparation of homeopathic stocks and potentisation: D:

Vorschriften zur Herstellung homöopathischer konzentrierter Zubereitungen und zur Potenzierung Fr : Méthodes de préparation des souches homéopathiques et déconcentration Es : Métodos de fabricación homeopáticos y potenciación It: Metodi di produzione di ceppi omeopatici e diluizioni NL : Homeopathische bereidingsmethodes FIN : Homeopaattisten kanta-aineiden ja laimennosten valmistusmenetelmät Por: Métodos de preparação de stocks homeopáticos e de desconcentração e dinamização Pl: Metody wytwarzania homeopatycznego preparatu wyjściowego i potencjonowania LV: Homeopātisko izejvielu pagatavošanas metodes un potencēšana HU: Homeopátiás kiindulási anyagok előállításának és potencírozásának módszerei Definitions and description of methods according to European Pharmacopoeia monograph 2371

Methods of preparation of homeopathic stocks and potentisation.

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Mother tincture: Symbol: MT, TM, Ø D: Fr: Es : It: NL : FIN: Por: Pl: LV: HU.

Urtinktur Teinture mère Tintura madre Tintura madre oertinctuur, moedertinctuur Kantaliuos Tintura mãe Roztwór macierzysty Mātes tinktūra (pamattinktūra) Őstinktúra

Definition according to European Pharmacopoeia, monograph 2029 Mother tinctures for homeopathic preparations . __________________________________________________________________________ Nosodes: D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Nosoden Nosodes Nosodes Nosodi Nosodes Nosodit Nosodos Nozody Nozodi Nozódák

Homeopathic preparations made from products of human or animal disease processes, from pathogens or their metabolic products, from the decomposition products of animal organs, or from cultured micro-organisms. References: Points to consider on Safety of Homeopathic medicinal products from Biological

origin. (July 2007)

German Homeopathic Pharmacopoeia (HAB), Chapter H, 5-2-5

___________________________________________________________________________ Organotherapy

D: Fr: It: NL: FIN: Por: Pl: LV: HU:

Organotherapie Organothérapie Organoterapia Organotherapie Organoterapia Organoterapia Organoterapia Orgānterapija Organoterápia

This therapy uses homeopathic medicinal products which are potentised extract(s) of a healthy animal organ. No official reference for definition

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___________________________________________________________________________ Polychrest D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Polychrest Polychreste Policrestos Policresti Polychrest Polykresti Policresto Polikrest Polikrests Polikreszt

Homeopathic remedies which are proved intensively with a wide spectrum of symptoms and for which there is a long documented experience in homeopathic practice. No official reference for definition ___________________________________________________________________________ Potentisation: D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Potenzierung Déconcentration Potenciación Processo di potenziamento (o dinamizzazione) Homeopathische potentiëring Laimentaminen – Potensoint Desconcentração e dinamização Potencjonowanie Potencēšana (atšķaidīšana) Potencírozás

Definition according to European Pharmacopoeia monograph 1038 Homeopathic preparations, and to European Pharmacopoeia monograph 2371 Methods of preparation of homeopathic

stocks and potentisation.

___________________________________________________________________________ Potentisation steps:

D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Potenzierungsstufen Etapes de déconcentration Etapas de potenciación Operazioni di potenziamento (o di diluizione e dinamizzazione) Verdunningsstappen Laimentamisvaiheet – Potensointivaiheet Etapas de desconcentração e dinamização Etapy potencjonowania (rozcieńczanie i dynamizacja) Potencēšanas (atšķaidīšanas) soļi Potencírozás lépései

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Definition according to European Pharmacopoeia monograph 1038 Homeopathic preparations, and to European Pharmacopoeia monograph 2371 Methods of preparation of homeopathic

stocks and potentisation.

___________________________________________________________________________ Raw material: D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Ausgangsstoffe Matière première Materia prima Materia prima Uitgangsstoffen, ruwe grondstoffen Lähtö-aine Matéria prima Surowiec wyjściowy Neapstrādātais materiāls Nyersanyag

Description according to European Pharmacopoeia monograph 1038 Homeopathic preparations, and to European Pharmacopoeia monograph 2029 Mother tinctures for homeopathic

preparations.

___________________________________________________________________________ Schüssler Salts: D: Aus: Fr: It: NL: FIN: Por: Pl: LV: HU:

Schüßler Salze Schüßler-Salze Sels de Schüssler Sali di Schüssler Schüssler zouten Schüsslerin suolat Sais de Schüssler Sole Schüsslera Šislera sāļi Schüssler sók

Homeopathic medicinal products (a selected number of inorganic salts in D6/D12) used according to the therapeutic method developed by WH Schüssler (1821-1895). No official reference for definition ___________________________________________________________________________ Similia principle / Simile principle D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Simile-Prinzip Loi de similitude / (Principe de similitude) Principio de similitud Legge di similitudine Similia-principe, Simila Wet Samanlaisuus periaate – Similia periaate Princípio da Similitude Zasada podobieństwa Līdzības princips Hasonlósági elv

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The underlying principle of homeopathy in which substances may be used therapeutically to treat signs and symptoms similar to those they induce in a healthy subject. No official reference for definition ___________________________________________________________________________ Succussion D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Verschütteln Dynamisation Sucusión Succussione Schudden Sukkussio Dinamização Wstrząsanie Dinamizācija (sakratīšana) Ütve rázás

In the manufacturing of homeopathic medicinal products, the process of agitating a liquid preparation. As intermediate step in the process of serial dilution, it is part of the potentisation process. No official reference for definition ___________________________________________________________________________ Trituration: D: Fr: Es: It: NL: FIN: Por: Pl: LV: HU:

Verreibungen Trituration Trituración

Triturazione Verwrijvingen Hierre Trituração Rozcierka Triturācija (saberšana) Trituráció

Homeopathic manufacturing method, a potentisation process effected by grinding together with lactose solid raw material (e.g. of mineral origin), mother tinctures, solutions and their dilutions as well as mixtures with lactose monohydrate as vehicle. Definition according to European Pharmacopoeia monograph 2371 Methods of preparation of

homeopathic stocks and potentisation

___________________________________________________________________________ Vehicle: D: Fr: Es: It:

Arzneiträger Véhicule /excipient Vehículo / excipiente Veicolo /eccipiente

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NL: BEL: FIN Por: Pl: LV: HU:

Excipiens, hulpstof Véhicule / draagstof Väliaine Veículo Nośnik Nesējviela Hordozó anyag, vehiculum

Definition according to European Pharmacopoeia, monograph 1038 Homeopathic preparations ___________________________________________________________________________

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