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Public Assessment Report UKPAR Ibuprofen 200 mg/ 5ml oral suspension (Ibuprofen) UK Licence No: PL 35533/0056 Aspire Pharma Limited.

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Page 1: Public Assessment Report UKPAR Ibuprofen 200 mg/ 5ml oral ... · PAR Ibuprofen 200 mg/ 5ml oral suspension PL 35533/0056 2 LAY SUMMARY Ibuprofen 200 mg/ 5ml oral suspension This is

Public Assessment Report

UKPAR

Ibuprofen 200 mg/ 5ml oral suspension

(Ibuprofen)

UK Licence No: PL 35533/0056

Aspire Pharma Limited.

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PAR Ibuprofen 200 mg/ 5ml oral suspension PL 35533/0056

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LAY SUMMARY

Ibuprofen 200 mg/ 5ml oral suspension

This is a summary of the Public Assessment Report (PAR) for Ibuprofen 200 mg/ 5ml oral suspension

(PL 35533/0056). It explains how Ibuprofen 200 mg/ 5ml oral suspension was assessed and its

authorisation recommended, as well as it’s conditions of use. It is not intended to provide practical

advice on how to use Ibuprofen 200 mg/ 5ml oral suspension.

The product will be collectively referred to as Ibuprofen oral suspension throughout the remainder of

this public assessment report.

For practical information about using Ibuprofen oral suspension, patients should read the package leaflet

or contact their doctor or pharmacist.

What is Ibuprofen oral suspension and what is it used for?

This medicine is the same as Ibuprofen 200 mg/5ml oral suspension (Aspire Pharma Limited), which is

already authorised. The company (Aspire Limited) that makes Ibuprofen 200 mg/5ml oral suspension

(PL 35533/0034) has agreed that its scientific data can be used as a basis for the grant of identical

licence for Ibuprofen oral suspension (PL 35533/0056).

Ibuprofen oral suspension is for use in children from 10 kg body weight (1 year of age), adolescents and

adults.

This medicine is used in the short-term treatment of:

• mild to moderate pain such as dental pain, headache.

• fever.

How does Ibuprofen oral suspension work?

Ibuprofen oral suspension contains the active ingredient ibuprofen which belongs to a group of

medicines called non-steroidal anti-inflammatory drugs (NSAID). This medicine reduces pain and fever.

How is Ibuprofen oral suspension used?

The pharmaceutical form of this medicine is an oral suspension and the route of administration is oral

(by mouth). This medicine can be taken without the need for a meal, but if the patient has a sensitive

stomach the medicine should be taken with a meal. The bottle should be shaken vigorously before use.

The patient should always take this medicine exactly as their doctor has told them. The patient should

check with their doctor or pharmacist if they are not sure.

This medicine is for short-term use only.

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PAR Ibuprofen 200 mg/ 5ml oral suspension PL 35533/0056

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The recommended dose is:

In children and adolescents Ibuprofen oral suspension is dosed depending on body weight (BW), as a

rule with 7 to 10 mg/kg BW as a single dose to a, maximum of 30 mg/kg BW as the total daily dose. The

interval between the doses should be at least 6 hours and the recommended dose should not be exceeded.

This medicine is not recommended for use in children under 1 year of age or under 10 kg body weight.

A doctor should be consulted if the child’s symptoms worsen or persist for more than 3 days.

Consult a doctor if an adolescent and or adult’s symptoms worsen, and this medicine is required to be

taken for more than 3 days in case of a fever, or more than 4 days for the treatment of pain.

Please read section 3 of the package leaflet for detailed information on dosing recommendations, the

route of administration, and the duration of treatment.

This medicine can only be obtained with a prescription.

For further information on how Ibuprofen oral suspension is used, refer to the package leaflet and

Summary of Product Characteristics (SmPC) available on the Medicines and Healthcare products

Regulatory Agency (MHRA) website.

What benefits of Ibuprofen oral suspension have been shown in studies?

Ibuprofen oral suspension is considered identical to previously authorised Ibuprofen 200 mg/5ml oral

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suspension (PL 35533/0034), with the same benefits and risks. So, no new studies have been provided

for Ibuprofen oral suspension, but reference is made to the studies for Ibuprofen 200 mg/5ml oral

suspension (PL 35533/0034).

What are the possible side effects from Ibuprofen oral suspension?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Ibuprofen oral suspension is considered to be identical to the previously authorised application for

Ibuprofen 200 mg/5ml oral suspension (PL 35533/0034) with the same benefits and risks.

For a full list of all the side effects reported with Ibuprofen oral suspension see section 4 of the package

leaflet, available on the Medicines and Healthcare products Regulatory Agency (MHRA) website.

For the full list of restrictions, see the package leaflet.

Why was Ibuprofen oral suspension approved?

The MHRA decided that the benefits of Ibuprofen oral suspension are greater than the risks and

recommended that it is approved for use.

What measures are being taken to ensure the safe and effective use of Ibuprofen oral suspension?

A Risk Management Plan has been developed to ensure that Ibuprofen oral suspension is used as safely

as possible. Based on this plan, safety information has been included in the Summary of Product

Characteristics and the package leaflet for Ibuprofen oral suspension including the appropriate

precautions to be followed by healthcare professionals and patients.

Known side effects are continuously monitored. Furthermore new safety signals reported by

patients/healthcare professionals will be monitored/reviewed continuously.

Other information about Ibuprofen oral suspension

Marketing Authorisation was granted in the UK on 21 December 2017.

The full PAR for Ibuprofen oral suspension follows this summary.

For more information about treatment with Ibuprofen oral suspension read the package leaflet, or contact

your doctor or pharmacist.

This summary was last updated in February 2018.

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TABLE OF CONTENTS

I Introduction Page 6

II Quality aspects Page 7

III Non-clinical aspects Page 8

IV Clinical aspects Page 8

V User consultation Page 9

VI Overall conclusion, benefit/risk assessment and

recommendation

Page 9

Table of content of the PAR update Page 13

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I INTRODUCTION

The Medicines and Healthcare products Regulatory Agency (MHRA) granted Aspire Pharma Limited

Marketing Authorisation for the medicinal product Ibuprofen 200 mg/ 5ml oral suspension (PL

35533/0056) on 21 December 2017. The product is a prescription only medicines (POM) used in the

short-term symptomatic treatment of:

• mild to moderate pain such as dental pain, headache.

• fever.

Ibuprofen oral suspension is for use in children from 10 kg body weight (1 year of age), adolescents and

adults.

This application was submitted as simple abridged (informed consent) application according to Article

10c of Directive 2001/83/EC, as amended.

The application cross-refers to the reference product Ibuprofen 200 mg/5ml oral suspension (PL

35533/0034), which was originally granted in the UK on 10 December 2014 to the marketing

authorisation holder (MAH) Aspire Pharma Limited, following a mutual recognition procedure

(DE/H/3978/001/MR) where the UK was a CMS. Subsequently the UK took over as RMS for this

procedure (UK/H/6039/01/MR) on 27 January 2015.

Ibuprofen oral suspension is a non-steroidal anti-inflammatory drug, which has been shown to be

effective through inhibition of prostaglandin synthesis in the usual animal models of inflammation. In

humans, ibuprofen reduces inflammation induced pain, swelling and fever. Furthermore, ibuprofen

reversibly inhibits ADP and collagen induced platelet aggregation.

Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid on

platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen

400mg was taken within 8 hours before or within 30 minutes after immediate release acetylsalicylic acid

dosing (81mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane or platelet

aggregation occurred. However, the limitations of these data and the uncertainties regarding

extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for

regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen

use.

No new data were submitted nor were necessary to be submitted for these applications, as the data are

identical to the data for the previously granted reference product.

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II QUALITY ASPECTS

II.1 Introduction

This is an abridged application for Ibuprofen oral suspension (PL 35533/0056) submitted under Article

10c of Directive 2001/83/EC, as amended.

The application cross-refers to the reference product Ibuprofen 200 mg/5ml oral suspension (PL

35533/0034), which was granted in the UK on 10 December 2014 to the marketing authorisation holder

(MAH) Aspire Pharma Limited.

II.2. Drug Substance

Drug substance specifications

The proposed drug substance specifications are consistent with the details registered for the cross-

reference product.

II.3. Medicinal Product

Name

The proposed product name for this application is Ibuprofen oral suspension 200 mg/ 5ml oral

suspension. The product has been named in line with current requirements.

Strength, pharmaceutical form, route of administration, container and pack sizes

Ibuprofen oral suspension is available in amber coloured polyethylene terephthalate (PET) bottles of 30

ml, 100 ml, 150 ml and 200 ml with a child-resistant closure, which is fitted with a low-density

polyethylene (LDPE) stopper. The product is supplied with a 5 ml oral syringe, comprising a high-

density polyethylene (HDPE) piston and a polypropylene barrel. The oral syringe is graduated in 0.25 ml

steps up to 5 ml. Not all pack-sizes may be marketed.

The proposed shelf life of the unopened product is 3 years with no special storage conditions.

The in-use shelf life of the product is 6 months after first opening the bottle.

The proposed packaging, shelf-life and storage conditions are consistent with the details registered for

the reference product.

Legal status

Prescription only medicine (POM).

Marketing Authorisation Holder/Contact Persons/Company

Aspire Pharma Limited, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG,

Unite Kingdom

Manufacturers

The proposed manufacturing sites are consistent with those registered for the reference product and

evidence of Good Manufacturing Practice (GMP) compliance has been provided.

Qualitative and quantitative compositions

The proposed compositions are consistent with the details registered for the reference product.

Manufacturing process

The proposed manufacturing processes are consistent with the details registered for the reference

product and the maximum batch size is stated.

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Finished product/shelf-life specifications

The proposed finished product specifications are in line with the details registered for the reference

product.

TSE Compliance

None of the excipients used contain material of animal or human origin.

This product does not contain or consist of genetically modified organisms (GMO).

Bioequivalence

No bioequivalence data are required to support this simple abridged application because the proposed

product is manufactured to the same formulae utilising the same processes as the reference product,

Ibuprofen 200 mg/5 ml oral suspension (PL 35533/0034).

Expert Report

The applicant cross-refers to the data for Ibuprofen 200 mg/5ml oral suspension (PL 35533/0034), to

which this application is claimed to be identical. This is acceptable.

Product Name and Appearance

See Section II.3 ‘Medicinal Product; Name’ for details of the proposed product name. The appearance of

the product is identical to that of the reference product.

II.4 Discussion on chemical, pharmaceutical and biological aspects

The data submitted with the application is acceptable. The grant of Marketing Authorisation is

recommended.

III NON-CLINICAL ASPECTS

Introduction

As this application is submitted under Article 10c of Directive 2001/83/EC, as amended, (Informed

Consent Applications) no new non-clinical data have been supplied and none are required.

Ecotoxicity/environmental risk assessment (ERA)

Suitable justification has been provided for non-submission of an Environmental Risk Assessment. As

the application is an identical version of already authorised product, it is not expected that environmental

exposure will increase following approval of the Marketing Authorisation for the proposed product.

Discussion on the non-clinical aspects

The grant of Marketing Authorisation is recommended.

IV CLINICAL ASPECTS

Introduction

As this application is submitted under Article 10c of Directive 2001/83/EC, as amended, (Informed

Consent Applications) no new clinical data have been supplied and none are required.

Risk Management Plan (RMP)

The marketing authorisation holder (MAH) has submitted a risk management plan (RMP), in accordance

with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities

and interventions designed to identify, characterise, prevent or minimise risks relating to Ibuprofen oral

suspension.

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The Qualified Person (QP) responsible for pharmacovigilance is stated and a satisfactory CV has been

provided.

A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, are

listed below:

Summary table of safety concerns:

Routine pharmacovigilance and routine risk minimisation are proposed for all safety concerns.

Discussion on the clinical aspects

The grant of Marketing Authorisation is recommended.

V User consultation

The package leaflet has been evaluated via a user consultation study in accordance with the requirements

of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for the purpose of user testing

the PIL was English

The results show that the package leaflet meets the criteria for readability as set out in the Guideline on

the readability of the label and package leaflet of medicinal products for human use.

VI Overall conclusion, benefit/risk assessment and recommendation

The quality of the product is acceptable, and no new non-clinical or clinical safety concerns have been

identified. The applicant’s product is identical to the reference product. Extensive clinical experience

with ibuprofen is considered to have demonstrated the therapeutic value of the compound. The

benefit/risk balance is, therefore, considered to be similar to the referenced product and positive.

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Summaries of Product Characteristics (SmPC), Patient Information Leaflets (PIL) and Labels

The SmPC and PIL are consistent with the details registered for the reference product.

In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPCs) and

Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are

available on the MHRA website.

The approved labelling for this medicine is presented below:

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Annex 1

Table of content of the PAR update

Steps taken after the initial procedure with an influence on the Public Assessment Report (Type II

variations, PSURs, commitments)

Scope Procedure

number

Product

information

affected

Date of

start of the

procedure

Date of end

of

procedure

Approval/

non

approval

Assessment

report

attached

Y/N

(version)