impetus cream pl 00173/0399 - medicines and healthcare ... · pdf filemhra par; impetus cream,...

MHRA PAR; IMPETUS CREAM, PL 00173/0399 1

Impetus Cream

PL 00173/0399

UKPAR

TABLE OF CONTENTS

Lay summary

Page 2

Scientific discussion

Page 3

Steps taken for assessment

Page 9

Summary of product characteristics

0

Patient information leaflet

Page 14

Labelling Page 17


IMPETUS CREAM

PL 00173/0399

LAY SUMMARY

The Medicines and Healthcare products Regulatory Agency (MHRA) granted a Marketing Authorisation (licence) for the medicinal product Impetus Cream (product licence number: PL 00173/0399) on 22 December 2010. Impetus Cream is available from pharmacies without prescription. Impetus Cream is an anti-microbial and emollient (softening and moisturising) treatment for dry or problem skin. It can be used as a leave-on application or as a soap substitute. It helps treat and prevent dry and itchy (pruritic) skin conditions, especially eczema and dermatitis. There are two types of active ingredient in this product: Benzalkonium chloride and chlorhexidine dihydrochloride are anti-microbial active ingredients. These help to:

- Combat bacteria present on the skin that can make eczema worse - Prevent infection caused by scratching itchy skin.

Liquid paraffin and isopropyl myristate are emollient active ingredients. These help to:

- Soften, moisturise and protect the skin by trapping moisture in the skin and restoring the normal protective function of the skin

- Prevent the skin-drying and irritant effects that can be caused by washing and bathing and by the soaps, foaming additives and fragrances used in ordinary skin cleansing products.

This product can be used in addition to any other emollients or treatments a doctor or pharmacist may have given or prescribed to treat the dry skin condition. Impetus Cream raised no clinically significant safety concerns and it was, therefore, judged that the benefits of using this product outweigh the risks; hence a Marketing Authorisation has been granted.


IMPETUS CREAM

PL 00173/0399

SCIENTIFIC DISCUSSION

TABLE OF CONTENTS Introduction

Page 4

Pharmaceutical assessment

Page 5

Preclinical assessment

Page 6

Clinical assessment

Page 7

Overall conclusions and risk benefit assessment Page 8


INTRODUCTION Based on the review of the data on quality, safety and efficacy, the UK granted a Marketing Authorisation for the medicinal product Impetus Cream to Diomed Developments Limited on 22 December 2010. This is an abridged application submitted under Article 10(c) of EC Directive 2001/83, last paragraph. The applicant claims that the product is identical to Dermol Cream (PL 00173/0171) which was licensed for use in the UK on 17 May 2004 to Diomed Developments Limited. No new data were submitted, nor was it necessary for this simple application, as the data are identical to those of the previously granted cross-reference product. Impetus Cream is indicated for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The cream is suitable for direct application, and for use as a soap substitute.


PHARMACEUTICAL ASSESSMENT

ACTIVE INGREDIENTS: LIQUID PARAFFIN, ISOPROPYL MYRISTATE, BENZALKONIUM CHLORIDE, CHLORHEXIDINE DIHYDROCHLORIDE The active ingredients liquid paraffin, isopropyl myristate, benzalkonium chloride and chlorhexidine dihydrochloride are the subjects of Ph Eur monographs and it has been stated that the drug substances used are in compliance with the requirement of the Ph Eur. The manufacturers of these active ingredients also supply the drug substances for the reference product. These active ingredients are, therefore, satisfactory. DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT The product is a white non-greasy cream containing the pharmaceutical excipients cetostearyl alcohol, glycerol, cetomacrogol 1000, phenoxyethanol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dehydrate and purified water. The product is stored in either a high density polyethylene squeezable bottle (500 g) with a polypropylene flip top cap, a high density polyethylene bottle (500 g) with a polypropylene metering pump, a high density polyethylene tube (100 g) with a polypropylene screw cap or a lacquered aluminium tube (30 g or 100 g) with a polyethylene screw cap. There is no difference between the composition and packaging of the proposed product and that of the already licensed cross reference product. The proposed shelf-lives (2 years for product stored in the 100g pack and 3 years for product stored in the 500g and 30g packs) and storage conditions (‘do not store above 30oC’ and ‘replace cap after use’) are consistent with the details registered for the reference product. ADDITIONAL DATA REQUIREMENTS The manufacturing process, finished product specifications and active ingredients’ specifications are in line with those for the reference product and are satisfactory. The applicant is also the Marketing Authorisation Holder of the reference product. Letters of Access are, therefore, not required EXPERT REPORTS Satisfactory expert reports in the form of quality, non-clinical and clinical overall summaries are provided, with signed declarations from each expert confirming that the applicant’s product is identical to the reference product in all particulars. Expert CVs are also submitted and are acceptable. PRODUCT LITERATURE The proposed SmPC, PIL and labels are identical to those for the reference product and are satisfactory. ASSESSOR’S OVERALL CONCLUSIONS A Marketing Authorisation may be granted for this product.


PRECLINICAL ASSESSMENT

No new preclinical data have been supplied with this application and none is required for an application of this type.


CLINICAL ASSESSMENT

OVERVIEW A statement has been provided confirming that the clinical particulars for Impetus Cream are identical to those for the already licensed product; Dermol Cream (PL 00173/0171). This is satisfactory.

BIOAVAILABILITY AND BIOEQUIVALENCE No bioequivalence study has been performed to support this application and none is needed. PRODUCT LITERATURE All product literature is medically satisfactory. ASSESSOR’S OVERALL CONCLUSIONS It is recommended that a Marketing Authorisation can be granted.


OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT

QUALITY Impetus Cream (PL 00173/0399) is identical to the already licensed reference product. This product is, therefore, pharmaceutically satisfactory. PRECLINICAL No new preclinical data were submitted and none are required for applications of this type. EFFICACY The efficacy of liquid paraffin, isopropyl myristate, benzalkonium chloride and chlorhexidine dihydrochloride is well established. The SmPC, PIL and labelling are satisfactory and consistent with those for the cross-reference products. RISK BENEFIT ASSESSMENT The quality of the product is acceptable, no significant preclinical or clinical safety concerns were identified, and benefit has been shown to be associated with liquid paraffin, isopropyl myristate, benzalkonium chloride and chlorhexidine dihydrochloride. The risk benefit ratio is, therefore, considered to be acceptable.


IMPETUS CREAM

PL 00173/0399

STEPS TAKEN FOR ASSESSMENT

1 The MHRA received the Marketing Authorisation application on 17 March 2007 2 Following standard checks and communication with the applicant the MHRA

considered the application valid on 14 June 2007 3 Following assessment of the application the MHRA requested further

information relating to the dossier on 16 September 2008 4 The applicant responded to the MHRA’s request, providing further information

on the dossier on 28 April 2010 5 The application was determined on 22 December 2010


SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Impetus Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Liquid Paraffin 10.0%w/w Isopropyl Myristate 10.0% w/w Benzalkonium Chloride 0.1% w/w Chlorhexidine Dihydrochloride 0.1% w/w For excipients, see 6.1

3 PHARMACEUTICAL FORM

Cream White non-greasy topical emulsion

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

An antimicrobial emollient cream for the management of dry and pruritic skin conditions, especially eczema and dermatitis. The cream is suitable for direct application, and for use as a soap substitute.

4.2 Posology and method of administration

For external use only. Before using the 500g pump bottle, turn the top of the pump dispenser anti-clockwise to unlock it. For adults, the elderly, infants and children. For application to the skin Apply Dermol Cream to the affected areas as often as necessary. For use as a soap substitute Dermol Cream may also be used as a cleanser in the bath or shower, or for other toiletry purposes, instead of ordinary soap or shower gel.

4.3 Contraindications

Do not use in cases of known sensitivity to any of the ingredients. 4.4 Special warnings and precautions for use

Avoid contact with the eyes. The excipient cetostearyl alcohol may on rare occasions give rise to local skin reactions (e.g. contact dermatitis) in sensitive people.


4.5 Interaction with other medicinal products and other forms of interaction None known.

4.6 Pregnancy and lactation

No special precautions. 4.7 Effects on ability to drive and use machines

None known. 4.8 Undesirable effects

Although the cream has been specially formulated for use on dry or problem skin, in the unlikely event of a reaction discontinue treatment. These reactions are very rare (<1/10,000, based on spontaneous reporting) and may be irritant or allergic in nature. Reactions have been observed occasionally when used excessively as a leave-on application in areas of folded skin such as the anogenital area.

4.9 Overdose

Excessive topical use is very unlikely to cause any untoward effects other than making the skin feel greasy. In the event of a significant quantity being accidentally swallowed, nausea and vomiting may occur but serious effects are unlikely. Unless there are signs that give cause for concern, treatment should be conservative.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: D02AX - Dermatologicals, other emollients and protectives. Bacteria (especially Staphylococcus aureus) are implicated in the pathogenesis of inflammatory dry skin conditions such as atopic eczema or dermatitis. Dermol Cream contains 20% of emollient oils in a non-greasy aqueous cream which also contains the well-known and effective antiseptics benzalkonium chloride and chlorhexidine dihydrochloride. Its antimicrobial properties assist in overcoming infection, whether from Staph aureus, the pathogen which often complicates eczema and associated pruritus, or secondary infection caused by scratching. Massaged into the skin, the emollients, liquid paraffin and isopropyl myristate, permit rehydration of dry skin by forming an occlusive barrier within the skin surface, thus reducing drying from evaporation of water that diffuses from the underlying layers.

5.2 Pharmacokinetic properties

The active ingredients are presented in an aqueous cream and so are readily absorbed into the stratum corneum when the product is gently massaged over


the areas of dry skin. The antiseptic ingredients are in intimate contact with the skin, and as they are in solution, their availability is optimal.

5.3 Preclinical safety data

No special information. 6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cetostearyl Alcohol Glycerol Cetomacrogol 1000 Phenoxyethanol Disodium Phosphate Dodecahydrate Sodium Dihydrogen Phosphate Dihydrate Purified Water

6.2 Incompatibilities

None known 6.3 Shelf life

500g & 30g packs – 3 years 100g pack – 2 years

6.4 Special precautions for storage

Do not store above 30oC. Replace cap after use.

6.5 Nature and contents of container

High density polyethylene squeezable bottle (500 g) with a polypropylene flip top cap. High density polyethylene bottle (500 g) with a polypropylene metering pump. High density polyethylene tube (100g) with a polypropylene screw cap. Lacquered aluminium tube (30, 100g) with a polyethylene screw cap.

6.6 Special precautions for disposal

Not applicable. 7 MARKETING AUTHORISATION HOLDER

Diomed Developments Limited T/A Dermal Laboratories Tatmore Place Gosmore Hitchin, Hertfordshire, SG4 7QR United Kingdom


8 MARKETING AUTHORISATION NUMBER(S) PL 00173/0399

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION 22/12/2010 10 DATE OF REVISION OF THE TEXT

22/12/2010


PATIENT INFORMATION LEAFLET


LABELLING

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