camilia oral solution nr 08822/0250 ukpar - gov.uk · mhra par; camilia oral solution, nr...

MHRA PAR; CAMILIA ORAL SOLUTION, NR 08822/0250

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Camilia Oral Solution

NR 08822/0250

UKPAR

TABLE OF CONTENTS

Lay summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

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Summary of Product Characteristics

Page 16

Product Information Leaflet

Page 19

Labelling Page 22


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CAMILIA ORAL SOLUTION

NR 08822/0250

LAY SUMMARY

The Medicines and Healthcare products Regulatory Agency (MHRA) granted BOIRON a Homeopathic Marketing Authorisation for the homeopathic medicinal product Camilia Oral Solution (Homeopathic Marketing Authorisation number: NR 08822/0250) on 17 August 2012. This product is available without prescription and can be bought from pharmacies and other outlets. Camilia Oral Solution is a homeopathic medicinal product used within the homeopathic tradition for the relief of teething pain and other minor symptoms associated with teething in babies and toddlers. These indications are based on homeopathic provings. The active ingredients in Camilia Oral Solution are Chamomilla vulgaris (in a final dilution of 9c), Phytolacca decandra (in a final dilution of 5c) and Rheum (in a final dilution of 5c). No new or unexpected safety concerns arose from this application and it was, therefore, decided that a Homeopathic Marketing Authorisation could be granted.


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NR 08822/0250

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS

Introduction

Page 4

Pharmaceutical assessment

Page 5

Non-clinical and clinical safety assessment

Page 11

Clinical assessment (non safety)

Page 12

Overall conclusions and risk assessment Page 14


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INTRODUCTION The MHRA granted a Homeopathic Marketing Authorisation for the homeopathic medicinal product Camilia Oral Solution on 17 August 2012. This product is on the General Sales List (GSL). The application was submitted in accordance with Article 16.2 of Directive 2001/83 EC, as amended, under the National Rules Authorisation Scheme. Camilia Oral Solution contains the homeopathic stocks Chamomilla vulgaris 9c, Phytolacca decandra 5c and Rheum 5c. It is used within the homeopathic tradition for the relief of teething pain and other minor symptoms associated with teething in babies and toddlers. Chamomilla vulgaris, Phytolacca decandra and Rheum are established homeopathic remedies and their traditional use in homoeopathy is well documented. In support of this application to authorise Camilia Oral Solution details of homeopathic provings have been provided.


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PHARMACEUTICAL ASSESSMENT

HERBAL SUBSTANCE: CHAMOMILLA VULGARIS

Scientific name of plant: Matricaria recutita L. Plant family: Asteraceae Part of plant used: Fresh whole flowering plant Manufacture of the Herbal Substance The Chamomilla vulgaris used in this product grows wild in France. The plants grow without the use of any artificial fertilizers, pesticides or herbicides. The plants are collected in the spring when in flower and transported to the manufacturer within 24 hours of collection. The supplier of the Chamomilla vulgaris has provided confirmation that the herbal substance is produced in accordance with the principles of Good Agricultural and Collection Practice (GACP) (EMEA/HMPC/246816/20050). Control of the Herbal Substance

Chamomilla vulgaris is described in the Ph Eur and French Pharmacopoeia monographs and the applicant refers to the specifications mentioned therein. As Chamomilla vulgaris is described in an official pharmacopoeia, analytical tests do not require further validation. Satisfactory Certificates of Analysis for Chamomilla vulgaris herbal substance have been provided.

Container Closure System Satisfactory details of the container closure system are provided and confirmation has been given that all components of the container closure system comply with current legislation relating to plastic materials and articles intended to come into contact with foodstuffs.

Stability of the Herbal Substance A shelf-life for the herbal substance is not necessary because it is used in a fresh state. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): CHAMOMILLA VULGARIS MOTHER

TINCTURE Extraction solvent: Ethanol 45% V/V General properties: A brown-yellow hydro-alcoholic solution Manufacture of Homeopathic Stock A satisfactory description of the manufacturing process of the homeopathic stock has been provided. Chamomilla vulgaris mother tincture is manufactured according to


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relevant Ph Eur and French Pharmacopoeia monographs. In-process controls are satisfactorily detailed. Certificates of Analysis confirm that the ethanol and purified water used to prepare the mother tincture comply with the specifications of the Ph Eur.

Control of Homeopathic Stock

A satisfactory specification with appropriate tests and limits has been provided for the homeopathic stock. Suitable analytical procedures are used to control the quality of the homeopathic stock. Analytical methods have been validated, as appropriate.

Certificates of Analysis have been provided for batches of the homeopathic stock, demonstrating satisfactory compliance with the proposed specifications. Container Closure System Satisfactory details of the container closure system are provided and confirmation has been given that all components of the container closure system comply with current legislation relating to plastic materials and articles intended to come into contact with foodstuffs.

Stability of Homeopathic Stock Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock.

HERBAL SUBSTANCE: PHYTOLACCA DECANDRA

Scientific name of plant: Phytolacca americana L. Plant family: Phytolaccaceae Part of plant used: Fresh whole plant with ripe berries Manufacture of the Herbal Substance The Phytolacca decandra used in this product grows wild in France. The plants grow without the use of any artificial fertilizers, pesticides or herbicides. The plants are collected in the spring when in flower and transported to the manufacturer within 24 hours of collection. The supplier of the Phytolacca decandra has provided confirmation that the herbal substance is produced in accordance with the principles of Good Agricultural and Collection Practice (GACP) (EMEA/HMPC/246816/20050). Control of the Herbal Substance

Phytolacca decandra is described in the Ph Eur and French Pharmacopoeia monographs and the applicant refers to the tests specifications mentioned therein. As Phytolacca decandra is described in an official pharmacopoeia, analytical tests do not require further validation.


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Satisfactory Certificates of Analysis for Phytolacca decandra herbal substance have been provided.


Stability of the Herbal Substance A shelf-life for the herbal substance is not necessary because it is used in a fresh state. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): PHYTOLACCA DECANDRA MOTHER

TINCTURE Extraction solvent: Ethanol 45% V/V General properties: A brown liquid Manufacture of Homeopathic Stock A satisfactory description of the manufacturing process of the homeopathic stock has been provided. Phytolacca decandra mother tincture is manufactured according to relevant Ph Eur and French Pharmacopoeia monographs. In-process controls are satisfactorily detailed. Certificates of Analysis confirm that the ethanol and purified water used to prepare the mother tincture comply with the specifications of the Ph Eur.




Stability of Homeopathic Stock Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock.


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HERBAL SUBSTANCE: RHEUM

Scientific name of plant: Rheum officinale Baillon or Rheum palmatum L Plant family: Polygonaceae Part of plant used: Dried underground parts Manufacture of the Herbal Substance The Rheum used in this product is cultivated in Asia. The plants are grown organically without the use of artificial fertilizers, pesticides or herbicides. The plants are harvested manually before the monsoon and transported protected from light. As the Rheum is supplied as a dried herbal substance, rapid processing after harvesting is not required. The supplier of the Rheum has provided confirmation that the herbal substance is produced in accordance with the principles of Good Agricultural and Collection Practice (GACP) (EMEA/HMPC/246816/20050). Control of the Herbal Substance

Rheum is described in the Ph Eur and French Pharmacopoeia monographs and the applicant refers to the tests specifications mentioned therein. As Rheum is described in an official pharmacopoeia, the analytical tests do not require further validation. Satisfactory Certificates of Analysis for Rheum herbal substance have been provided.


Stability of the Herbal Substance Appropriate tests are carried out on all batches used to manufacture the mother tincture, stability data are, therefore, not needed. ACTIVE INGREDIENT (HOMEOPATHIC STOCK): RHEUM MOTHER TINCTURE Extraction solvent: Ethanol 65%V/V General properties: Dark brown liquid, colouring the walls of the

flask yellow Manufacture of Homeopathic Stock A satisfactory description of the manufacturing process of the homeopathic stock has been provided. Rheum mother tincture is manufactured according to relevant Ph Eur and French Pharmacopoeia monographs. In-process controls are satisfactorily detailed. Certificates of Analysis confirm that the ethanol and purified water used to prepare the mother tincture comply with the specifications of the Ph Eur.


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Stability of Homeopathic Stock Stability studies have been carried out and the results support the proposed shelf life of the homeopathic stock. HOMEOPATHIC MEDICINAL PRODUCT: CAMILIA ORAL SOLUTION

Description and Composition of the Homeopathic Product The finished product is a clear, colourless, oral solution containing a combination of Chamomilla vulgaris in a centesimal dilution of 9c, Phytolacca decandra in a centesimal dilution of 5c and Rheum in a centesimal dilution of 5c. The excipient used to manufacture the homeopathic medicinal product is purified water. This excipient is of pharmacopoeial quality, is considered to be compatible with the homeopathic stocks and does not influence the performance of the product. Certificates of Analysis for the excipients have been provided by the supplier.

Manufacture of Homeopathic Product A flow diagram outlining the various stages of the manufacturing process and the in-

process controls is provided. The dilutions of each homeopathic stock are mixed using an appropriate method. Process validation was carried out on product batches and the results confirm that the manufacturing process is well controlled and results in a finished product of appropriate quality. The production process is considered validated. Control of Homeopathic Product The finished product specification is detailed and the tests and limits used were found to be satisfactory for a product of this nature.

Suitable analytical procedures are used to control the quality of the homeopathic product. Analytical methods have been validated, as appropriate.

Certificates of Analysis have been provided for batches of the homeopathic product, demonstrating satisfactory compliance with the proposed specifications.


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Container Closure System The product is presented in single-dose containers (low density polyethylene). Cartons containing 10, 20 or 30 single-dose containers have been authorised, although not all pack sizes may be marketed. Confirmation has been given that all components of the container closure system comply with current legislation relating to plastic materials and articles intended to come into contact with foodstuffs.

Stability of Homeopathic Product Stability studies were conducted under ICH conditions on product batches in the

container type proposed for marketing. The product has a shelf life of 36 months when stored in an unopened container; once the container is opened the product should be used immediately. Summary of Product Characteristics, Labels and Patient Information Leaflet The product literature for this product is pharmaceutically satisfactory. A package leaflet has been submitted to the MHRA together with results of consultations with target patient groups ("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that it contains. CONCLUSION There are no objections to the granting of a Homeopathic Marketing Authorisation from a quality point of view.


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NON-CLINICAL AND CLINICAL SAFETY ASSESSMENT SAFETY OVERVIEW The applicant has presented an overview of the safety of the three homeopathic stocks and concluded that it is highly unlikely that they will exert any acute or chronic toxic effects or any genotoxic effects. The applicant has not provided any new safety data in support of their application. This is justified on the basis that the product is derived from stocks present in products registered under the Simplified Registration Scheme or licensed medicinal products and that the stocks are diluted to an appropriate level. CONCLUSION There are no objections to the granting of a Homeopathic Marketing Authorisation from a safety point of view.


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CLINICAL ASSESSMENT (NON SAFETY)

LEGAL STATUS Chamomilla vulgaris, Phytolacca decandra and Rheum are listed on the General sales List, therefore, Camilia Oral Solution is suitable for General Sales. INDICATION The applicant has proposed the following indication: “A homeopathic medicinal product used within the homeopathic tradition for the relief of teething pain and other minor symptoms associated with teething in babies and toddlers.” This indication is acceptable. POSOLOGY AND METHOD OF ADMINISTRATION The applicant has proposed the following “Oral use. Camilia Oral Solution is suitable for use in infants and toddlers aged from 1 month up to 2 years and children aged from 2 years up to 6 years.

Posology: The usual dose is the contents of 1 single-dose container, 2 to 3 times a day. Treatment should not exceed 3 days. If symptoms worsen or persist for more than 3 days, a doctor or qualified healthcare practitioner should be consulted.

Method of administration: Open the sachet. Detach a single-dose container from the stick. Carefully close the sachet containing the other single-dose containers by folding over the opened side. Open the single-dose container by twisting the nozzle. Pour the contents of the single-dose container into the child's oral cavity while maintaining the child in a sitting position.” This is acceptable. EVIDENCE SUPPORTING THE PROPOSED INDICATION Schedule 1A Parts 1 and 3 of SI 2006 No. 1952 The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006 specifies the data that must be provided to support the use of the product in the indications sought. No new clinical data were submitted and none are required for an application of this type. In support of this application details of homeopathic provings have been provided. These are adequate evidence to support the indications for which this National Rules Authorisation is sought.


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CONCLUSION It is considered sufficient evidence has been submitted to justify the homeopathic use of Camilia Oral Solution for the relief of teething pain and other minor symptoms associated with teething in babies and toddlers. There are no objections to the granting of a Homeopathic Marketing Authorisation from a clinical point of view.


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OVERALL CONCLUSION AND RISK ASSESSMENT QUALITY The quality data submitted with this application are satisfactory. NON-CLINICAL AND CLINICAL SAFETY ASSESSMENT No new non-clinical data were submitted and none are required for an application of this type. CLINICAL ASSESSMENT (NON SAFETY) The applicant has provided homeopathic provings as supporting evidence to fulfil the requirements for this type of application. These provings relate to the indications sought and are, therefore, acceptable. The SmPC, PIL and labelling of the product are satisfactory. RISK ASSESSMENT AND CONCLUSION The quality of the product is acceptable and no new non-clinical or clinical safety concerns have been identified. A Homeopathic Marketing Authorisation may be granted.


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NR 08822/0250

STEPS TAKEN FOR ASSESSMENT

1 The MHRA received an application under the Homeopathic National Rules Scheme (Article 16.2) on 13 October 2010

2 Following standard checks and communication with the applicant the MHRA considered the application valid on 22 October 2010

3 Following assessment of the application and a meeting of the Advisory Board on the Registration of Homeopathic products (ABRH) on 15 February 2011, the MHRA requested further information relating to the dossier on 24 February 2011

4 The applicant responded to the MHRA’s request, providing further information on the dossier on 3 August 2011

5 Following assessment of the response the MHRA requested further information relating to the dossier on 10 October 2011

6 The applicant responded to the MHRA’s request, providing further information on the dossier on 16 December 2011

7 Following assessment of the response the MHRA requested further information relating to the dossier on 20 April 2012

8 The applicant responded to the MHRA’s request, providing further information on the dossier on 14 June 2012

9 A National Rules Marketing Authorisation was granted on 17 August 2012


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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Camilia Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains: Chamomilla vulgaris 9c Phytolacca decandra 5c Rheum 5c For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral solution. Clear, colourless solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A homeopathic medicinal product used within the homeopathic tradition for the relief of teething pain and other minor symptoms associated with teething in babies and toddlers.

4.2 Posology and method of administration

Oral use. Camilia Oral Solution is suitable for use in infants and toddlers aged from 1 month up to 2 years and children aged from 2 years up to 6 years. Posology: The usual dose is the contents of 1 single-dose container, 2 to 3 times a day. Treatment should not exceed 3 days. If symptoms worsen or persist for more than 3 days, a doctor or qualified healthcare practitioner should be consulted. Method of administration: Open the sachet. Detach a single-dose container from the stick. Carefully close the sachet containing the other single-dose containers by folding over the opened side. Open the single-dose container by twisting the nozzle. Pour the contents of the single-dose container into the child's oral cavity while maintaining the child in a sitting position.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.


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4.4 Special warnings and precautions for use

Do not exceed the stated dose. The contents of the container should be used immediately after opening and any unwanted solution should be discarded. This product is not recommended for infants under 1 month old. If symptoms worsen or persist for more than 3 days, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction None known. 4.6 Fertility, pregnancy and lactation

The use of this product in pregnancy and lactation is not applicable. However, if use in pregnancy and lactation is required, the advice of a doctor should be sought.

4.7 Effects on ability to drive and use machines

None known. 4.8 Undesirable effects

There are no known adverse effects. If adverse effects occur, a doctor or pharmacist should be consulted.

4.9 Overdose

No case of overdose has been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Homeopathic medicinal product, ATC code: V03AX

5.2 Pharmacokinetic properties

Not applicable. 5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified water 6.2 Incompatibilities

None stated.


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6.3 Shelf life 36 months. Once opened use immediately.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container

Clear, colourless solution in single-dose containers (low density polyethylene). Each carton contains 10, 20 or 30 single-dose containers. Not all pack sizes may be marketed.

6.6 Special precautions for disposal No special requirements.

7 MARKETING AUTHORISATION HOLDER

BOIRON 20 rue de la Libération F-69110 Sainte-Foy-lès-Lyon

8 MARKETING AUTHORISATION NUMBER(S) NR 08822/0250 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 17/08/2012 10 DATE OF REVISION OF THE TEXT

17/08/2012


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PATIENT INFORMATION LEAFLET


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LABELLING

Labels:


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Cartons:


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camilia oral solution nr 08822/0250 ukpar - gov.uk · mhra par; camilia oral solution, nr...

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