Public Assessment Report UKPAR - GOV.UK 120 mg/5 ml Oral Suspension PL 04917/0083 1 Public...

Paracetamol 120 mg/5 ml Oral Suspension PL 04917/0083

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Public Assessment Report

UKPAR

Junior Paracetamol 120 mg/5 ml Suspension Sugar

Free, Colour Free/Paracetamol 120 mg/5 ml Oral

Suspension/Junior Parapaed 120mg/5ml Oral

Suspension

(paracetamol)

UK Licence No: PL 04917/0083

Pinewood Laboratories Limited


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LAY SUMMARY Junior Paracetamol 120 mg/5 ml Suspension Sugar Free, Colour Free

Paracetamol 120 mg/5 ml Oral Suspension

Junior Parapaed 120mg/5ml Oral Suspension

(Paracetamol)

This is a summary of the Public Assessment Report (PAR) for Junior Paracetamol 120 mg/5 ml

Suspension Sugar Free, Colour Free/Paracetamol 120 mg/5 ml Oral Suspension/Junior Parapaed

120mg/5ml Oral Suspension (PL 04917/0083). It explains how this product was assessed and its

authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice

on how to use this product, hereafter referred to as Paracetamol 120 mg/5 ml Oral Suspension.

For practical information about using Paracetamol 120 mg/5 ml Oral Suspension, patients should read

the package leaflet or contact their doctor or pharmacist.

What is Paracetamol 120 mg/5 ml Oral Suspension and what is it used for?

This product contains the active ingredient paracetamol. It is used to relieve pain and reduce high

temperatures. It can be used in babies and children for the treatment of pain and feverishness associated

with teething, toothache, headache, colds and flu. It can also be used in babies who develop fever after

vaccination.

This medicine is identical to Junior Parapaed Paracetamol Sugar Free Colour Free 120mg/5ml Oral

Solution (PL 04917/0028), which was first granted a Marketing Authorisation (Pinewood Laboratories

Limited) on 25 May 1999.

How is Paracetamol 120 mg/5 ml Oral Suspension used?

This medicine is available from pharmacies without a prescription.

When used for the relief of fever after vaccination at 2, 3 and 4 months, the dose is 2.5 ml. This dose

may be given up to 4 times a day starting at the time of vaccination. Babies should not be given more

than 4 doses in any 24 hour period and there should be at least 4 hours between doses. If the baby still

needs this medicine two days after receiving the vaccine, the carer-giver should talk to a doctor or

pharmacist.

This product can be used for babies aged 2-3 months for the treatment of pain and other causes of fever

if the baby weighs over 4 kg and was born after 37 weeks. The dose is 2.5 ml. If necessary, after 4-6

hours, a second 2.5 ml dose can be given. This medicine should not be given to babies less than 2

months of age and babies aged 2-3 months should not be given more than 2 doses. This is to ensure that

fever that may be due to a serious infection is quickly diagnosed. If the child is still feverish after two

doses, a doctor or pharmacist should be contacted. There should be at least 4 hours between doses.

For babies and children aged 3 months to six years the dose differs according to the table below:


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How does Paracetamol 120 mg/5 ml Oral Suspension work?

This product contains the active ingredient paracetamol. Paracetamol is a pain reliever (analgesic) and

helps reduce the patient’s body temperature when they have a fever.

What benefits of Paracetamol 120 mg/5 ml Oral Suspension have been shown in studies?

The application for Paracetamol 120 mg/5 ml Oral Suspension is considered to be identical to the

previously authorised application for Junior Parapaed Paracetamol Sugar Free Colour Free 120mg/5ml

Oral Solution (PL 04917/0028), with the same benefits and risks, so no new studies have been provided.

The company referred to the data provided for the grant of the licence for Junior Parapaed Paracetamol

Sugar Free Colour Free 120mg/5ml Oral Solution (PL 04917/0028) as a basis for the grant of an

identical licence for Paracetamol 120 mg/5 ml Oral Suspension (PL 04917/0083).

What are the possible side effects of Paracetamol 120 mg/5 ml Oral Suspension?

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

Paracetamol 120 mg/5 ml Oral Suspension (PL 04917/0083) is considered to be identical to the

previously authorised application for Junior Parapaed Paracetamol Sugar Free Colour Free 120mg/5ml

Oral Solution (PL 04917/0028) with the same benefits and risks.

For a full list of all the side effects reported with Paracetamol 120 mg/5 ml Oral Suspension see section

4 of the package leaflet, available on the Medicines and Healthcare products Regulatory Agency

(MHRA) website.

Why is Paracetamol 120 mg/5 ml Oral Suspension approved?

No new or unexpected safety concerns arose from this application. The MHRA, therefore, considered

that the benefits of Paracetamol 120 mg/5 ml Oral Suspension outweigh its risks; and the grant of a

Marketing Authorisation (licence) was recommended.

What measures are being taken to ensure the safe and effective use of Paracetamol 120 mg/5 ml

Oral Suspension?

Safety information has been included in the Summary of Product Characteristics and the package leaflet

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 Paracetamol 120 mg/5 ml Oral Suspension

Marketing Authorisations were granted in the UK on 27 November 2009.

The full PAR for Paracetamol 120 mg/5 ml Oral Suspension follows this summary.


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For more information about treatment with Paracetamol 120 mg/5 ml Oral Suspension read the package

leaflet, or contact your doctor or pharmacist.

This summary was last updated in March 2016.


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TABLE OF CONTENTS

I Introduction Page 6

II Quality aspects Page 7

III Non-clinical aspects Page 9

IV Clinical aspects Page 9

V User consultation Page 9

VI Overall conclusion, benefit/risk assessment and

recommendation

Page 9

Annex 1 Table of content of the PAR update

Page 12


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I INTRODUCTION

Based on the review of the data on quality, safety and efficacy, the UK granted a Marketing

Authorisation for the medicinal product Paracetamol 120 mg/5 ml Oral Suspension to Pinewood

Laboratories Limited on 27 November 2009.

This is an abridged application for Paracetamol 120 mg/5 ml Oral Suspension submitted under Article

10c of Directive 2001/83/EC as amended. The applicant claims that this product is identical to Junior

Parapaed Paracetamol Sugar Free Colour Free 120mg/5ml Oral Solution (PL 04917/0028), which was

licensed for use in the UK on 25 May 1999 to Pinewood Laboratories 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.

Paracetamol 120 mg/5 ml Oral Suspension is indicated for the treatment of mild to moderate pain and as

an anti-pyretic. It is also used for the relief of pain and feverishness associated with teething, toothache,

headache, colds, flu and post-immunisation pyrexia.

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin

and dependent on the inhibition of prostaglandin synthesis. This inhibition appears, however, to be on a

selective basis.


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II QUALITY ASPECTS

II.1 Introduction

This is an informed consent application for Paracetamol 120 mg/5 ml Oral Suspension submitted under

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

The application cross-refers to Junior Parapaed Paracetamol Sugar Free Colour Free 120mg/5ml Oral

Solution (PL 04917/0028) which was first authorised to Pinewood Laboratories Limited on 25 May

1999. The application is considered valid.

II.2. Drug Substance

Drug substance specification

The proposed drug substance specification is consistent with the details registered for the cross-reference

product.

II.3. Medicinal Product

Name

The proposed product names are Junior Paracetamol 120 mg/5 ml Suspension Sugar Free, Colour Free,

Paracetamol 120 mg/5 ml Oral Suspension and Junior Parapaed 120mg/5ml Oral Suspension. The

product has been named in line with current requirements.

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

The product is an oral suspension containing 120mg of paracetamol per 5 ml of liquid.

The finished product is packed in pharmaceutical grade III amber glass bottles each with a child

resistant, tamper evident cap in pack sizes of 70 ml and 100 ml. A spoon with a 5 ml and 2.5 ml measure

is supplied.

The proposed shelf life of the unopened product is 5 years with the storage conditions ‘Do not store

above 25°C’, ‘Store in the original container’ and ‘Keep container in the outer carton’.

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

the cross-reference product.

Legal status

On approval, the product will be available as a General Sales List medicine (GSL).

Marketing Authorisation Holder/Contact Persons/Company

Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co Tipperary, Ireland

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

provided.

Manufacturers

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

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

Qualitative and quantitative composition

The proposed composition is consistent with the details registered for the cross-reference product.


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Manufacturing process

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

product and the maximum batch size is stated.

Finished product/shelf-life specification The proposed finished product specification is in line with the details registered for the cross-reference

product.

TSE Compliance

None of the excipients contain materials of animal or human origin. This is consistent with the

cross-reference product.

Bioequivalence

No bioequivalence data are required to support this informed consent application because the proposed

product is manufactured to the same formula utilising the same processes as the cross-reference product.

Expert Report

The applicant cross-refers to the data for Junior Parapaed Paracetamol Sugar Free Colour Free

120mg/5ml Oral Solution (PL 04917/0028) 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 names. The appearance

of the product is identical to that of the cross-reference product.

II.4 Discussion on chemical, pharmaceutical and biological aspects

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

recommended.


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III NON-CLINICAL ASPECTS

Introduction

As this is an informed consent application submitted under Article 10c of Directive 2001/83/EC, as

amended, 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 an 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 a Marketing Authorisation is recommended.

IV CLINICAL ASPECTS

Introduction

As this is an informed consent application submitted under Article 10c of Directive 2001/83/EC, as

amended, no new clinical data have been supplied and none are required.

The Pharmacovigilance System, as described by the applicant, fulfils the requirements and provides

adequate evidence that the applicant has the services of a qualified person responsible for

pharmacovigilance, and has the necessary means for the notification of any adverse reaction suspected

of occurring either in the Community or in a third country.

Discussion on the clinical aspects

The grant of a Marketing Authorisation is recommended.

V USER CONSULTATION

The package leaflet has been evaluated in accordance with the requirements of Articles 59(3) and 61(1)

of Directive 2001/83/EC, as amended. 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 cross-reference product. Extensive clinical

experience with paracetamol is considered to have demonstrated the therapeutic value of the compound.

The benefit/risk balance is, therefore, considered to be positive.


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

The Summary of Product Characteristics and Patient Information Leaflet (PIL) are consistent with the

details registered for the cross-reference product.

In accordance with Directive 2010/84/EU the Summary of Product Characteristic (SmPC) and Patient

Information Leaflet (PIL) for products granted Marketing Authorisations at a national level are available

on the MHRA website.

The currently approved labelling 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

Scope Procedure

number

Product

Information

affected

Date of

start of the

procedure

Date of

end of

procedure

Approval/

non

approval

Assessment

report

attached

Type IB variation

to update 4.2

(Posology and

administration) and

4.4 (Special

warnings) of the

SmPC in line with

the Paracetamol

warnings following

advice from CHM.

Consequently, the

PIL has been

updated.

PL

04917/0083 -

0040

SmPC and

PIL

25/01/16 08/02/16 Approved Y

(annex 2)


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Annex 2

Reference: PL 04917/0083 - 0040

Product: Junior Paracetamol 120 mg/5 ml Suspension Sugar Free, Colour

Free

Paracetamol 120 mg/5 ml Oral Suspension

Junior Parapaed 120mg/5ml Oral Suspension

Marketing Authorisation Holder: Pinewood Laboratories Limited

Active Ingredient(s): Paracetamol

Reason:

Type IB variation to update sections 4.2 (Posology and administration) and 4.4 (Special warnings) of the

SmPC in line with the paracetamol warnings, following advice from the Commission on Human

Medicines (CHM). Consequently, the PIL has been updated.

Supporting Evidence

Revised SmPC fragments 4.2 and 4.4 and a revised PIL have been provided.

The majority of the changes are typographical and editorial in nature and require no further supportive

evidence.

The inclusion of the separate box detailing the dosing instructions for babies of 2, 3 and 4 months of age

with regard to post vaccination symptoms, adequately clarifies the instructions, outlining specifically

doses, dose intervals and maximal daily posologies. This is considered appropriate.

Evaluation

The amended sections of the SmPC are satisfactory.

The current approved UK version of the SmPC and PIL are available on the MHRA website.

Decision

Approved on 08 February 2016.

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