FSD Atropa bella-donna Rh (manufacturing method GHP 21)

HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP

(HMPWG)

list ENTRY of first safe dilution

1. Rheum Officinale Ballon or Rheum PalmatumEuropean Pharmacopoeia (Ph. Eur.) in force monograph 2371: Method of preparation Ph. Eur. 1.1.10 and Ph. Eur. 1.1.8. of Homoeopathic Stocks and Potentisation2. Matricaria recutita L.European Pharmacopoeia (Ph. Eur.) in force monograph 2371: Method of preparation Ph. Eur. 1.1.10 and Ph. Eur. 1.1.5. of Homoeopathic Stocks and PotentisationDISCUSSION IN THE SUBGROUP

Discussion in the HMPWG

ADOPTION BY THE HMPWG

TRANSMISSION TO HMA for release for consultation

DEADLINE FOR COMMENTS

Identity of the stock*/raw/starting material/, **

Name Ph.Eur.

Name national Ph.

Ref. to monograph

Synonyms

Plant part

Fresh/dried Preparation

Homeopathic Manufact. Method/

Method of preparation

Constituents of toxicological concern

(international nomenclature, CAS #)Acceptable amount mg/kg/day based on PDE /TTC/(LHRD/100)

First Safe dilution

(as defined point 3.4 in the points to consider)

Toxicological Comments

e.g. target organs, major toxic concern,

patients groups with special concern for which the use is not recommended

Known toxic or possibly toxic Substances

with max % in raw/starting material/ stock (to be specified, if possible

Not knownBased on stock/raw/starting material/ (to be specified)

Based on known or possible toxic constituent

Rheum officinale Baillon

Rheum palmatum L. Ph. Fr.

underground parts driedEuropean Pharmacopoeia (Ph. Eur.) in force monograph 2371: Method of preparation Ph. Eur. 1.1.10 of Homoeopathic Stocks and Potentisation3 to 12 % hydroxanthracene derivativesTTC = 0.15*10-3 mg/dayFSDMT = 7 D (expressed relative to the dried plant)Use of the TTC concept to have any contraindication.

Rheum officinale Baillon

Rheum palmatum L. GHP

underground parts driedEuropean Pharmacopoeia (Ph. Eur.) in force monograph 2371: Method of preparation Ph. Eur. 1.1.8 of Homoeopathic Stocks and Potentisation3 to 12 % hydroxanthracene derivativesTTC = 0.15*10-3 mg/dayFSDMT = 8 D (expressed relative to the dried plant)

Use of the TTC concept to have any contraindication

Matricaria recutita L. matricaria chamomilla L. Ph. Fr.

whole flowering plant FreshEuropean Pharmacopoeia (Ph. Eur.) in force monograph 2371: Method of preparation Ph. Eur. 1.1.10 of Homoeopathic Stocks and PotentisationNo sever toxic components :Cumarins; essential oil; flavonodsFood legislation: intake limited by limited maximal amount of ingested -bisabolol (1.9mg) and apigenine-7-glucoside (5.6mg). in the calculation of the FSD, the content in apigenine-7-glucoside is the critical factor and determine the FSDFSD = 2DTaking into account the fact that allergies are dependent of the sensibility of each individual, BE proposes, by analogy to the proposal for excipients, to put a special warning on the packaging.

Matricaria recutita L. matricaria chamomilla L. Ph. Fr.

whole flowering plant FreshEuropean Pharmacopoeia (Ph. Eur.) in force monograph 2371: Method of preparation Ph. Eur. 1.1.5 of Homoeopathic Stocks and PotentisationNo sever toxic components :

Cumarins; essential oil; flavonodsFood legislation: intake limited by limited maximal amount of ingested -bisabolol (1.9mg) and apigenine-7-glucoside (5.6mg). in the calculation of the FSD, the content in apigenine-7-glucoside is the critical factor and determine the FSDFSD = 3DTaking into account the fact that allergies are dependent of the sensibility of each individual, BE proposes, by analogy to the proposal for excipients, to put a special warning on the packaging.

* As defined in the Ph. Eur.

** For information related to the identity, refer to Guidance on module 3 of the homeopathic medicinal product dossier http://www.hma.eu/uploads/media/HMPWG_dossier_guidance_mod3.pdf