Public Assessment Report
UKPAR
Paroxetine 10 mg, 20 mg, 30 mg and 40 mg
Film-coated tablets
(paroxetine hydrochloride hemihydrate)
UK licence Number: PL 30322/0025-0028
Alissa Healthcare Research Limited
UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
LAY SUMMARY
Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
(Paroxetine, Paroxetine Hydrochloride Hemihydrate)
PL 30322/0025-0028
This is a summary of the Public Assessment Report (PAR) for Paroxetine 10 mg, 20
mg, 30 mg and 40 mg Film-coated tablets (PL 30322/0025-0028). These medicinal
products will be referred to as Paroxetine Film-coated tablets in the remainder of the
report for ease of reading.
This summary explains how Paroxetine Film-coated tablets were assessed and their
authorisations recommended, as well as their conditions of use. It is not intended to
provide practical advice on how to use these products.
For practical information about using Paroxetine Film-coated tablets, patients should
read the patient information leaflet available on the MHRA website or contact their
doctor or pharmacist.
What are Paroxetine Film-coated tablets and what are they used for?
Paroxetine is a treatment for adults with depression and/or anxiety disorders,
specifically obsessive compulsive disorder (repetitive, obsessive thoughts with
uncontrollable behaviour), panic disorder (panic attacks, including those caused by
agoraphobia, which is a fear of open spaces), social anxiety disorder (fear or
avoidance of social situations), post-traumatic stress disorder (anxiety caused by a
traumatic event) and generalised anxiety disorder (generally feeling very anxious or
nervous).
How do Paroxetine Film-coated tablets work?
Paroxetine is one of a group of medicines called selective serotonin reuptake
inhibitors (SSRIs). Everyone has a substance called serotonin in their brain. People
who are depressed or anxious have lower levels of serotonin than others. It is not fully
understood how Paroxetine and other SSRIs work, but they may help by increasing
the levels of serotonin in the brain. Treating depression or anxiety disorders properly
is important to help the patient get better.
How are Paroxetine Film-coated tablets used?
The patient should always take this medicine exactly as their doctor or pharmacist has
told them. They should check with their doctor or pharmacist if they are not sure.
Paroxetine Film-coated tablets are swallowed with a drink of water and should not be
chewed. This medicine should be taken in the morning with food.
Sometimes the patient may need to take more than one tablet or half a tablet. The 20
mg tablet can be divided into equal doses.
The usual doses for different conditions are set out in the table below:
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
Most people start to feel better after a couple of weeks. If the patient does not start to
feel better after this time, they should talk to their doctor, who will advise them. He or
she may decide to increase the dose gradually, 10 mg at a time, up to a maximum
daily dose.
The maximum dose for elderly people over 65 is 40 mg per day.
Patients with liver or kidney disease may be given a lower dose of paroxetine than
usual.
This medicine can only be obtained with a prescription from a doctor.
Please read Section 3 of the patient information leaflet for detailed information on
dosing recommendations, the route of administration and the duration of treatment.
How have Paroxetine Film-coated tablets been studied?
These products are identical to their respective cross-reference products Paroxetine
10mg Film-coated tablets (PL 19156/0134), Paroxetine 20mg Film-coated tablets
(PL 19156/0135), Paroxetine 30mg Film-coated tablets (PL 19156/0136) and
Paroxetine 40mg Film-coated tablets (PL 19156/0137), which were granted Market
Authorisations to Jubilant Pharmaceuticals nv on 25 June 2015.
What are the possible side effects of Paroxetine Film-coated tablets?
The possible side-effects observed with Paroxetine Film-coated tablets are the same as
those observed with the cross-reference products.
For further information, please see Section 4 of the patient information leaflet.
Why is Paroxetine Film-coated tablets approved?
It was concluded that, in accordance with EU requirements Paroxetine Film-coated
tablets are identical to the cross-reference products that have been granted licences in
the UK.
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
What measures are being taken to ensure the safe and effective use of Paroxetine
Film-coated tablets?
A risk management plan (RMP) has been developed to ensure that Paroxetine Filmcoated tablets are used as safely as possible. Based on this plan, safety information
has been included in the Summary of Product Characteristics and the patient
information leaflet for Paroxetine Film-coated tablets, including the appropriate
precautions to be followed by patients.
Known side-effects are continuously monitored. Furthermore, new safety signals
reported by patients and healthcare professionals will be monitored and reviewed
continuously, as well.
Other information about Paroxetine Film-coated tablets
The UK granted marketing authorisations for Paroxetine Film-coated tablets on 2
February 2017. The full PAR for Paroxetine Film-coated tablets follows this
summary. For more information about treatment with Paroxetine Film-coated tablets,
read the patient information leaflet or contact your doctor or pharmacist. This
summary was last updated in March 2017.
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
TABLE OF CONTENTS
I
II
III
IV
V
VI
Introduction
Quality aspects
Non-clinical aspects
Clinical aspects
User consultation
Overall conclusion, benefit/risk assessment
and recommendation
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Page 7
Page 9
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Page 10
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Table of content of the PAR update
Page 15
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
I
INTRODUCTION
Based on the review of the data on quality, safety and efficacy, the MHRA considered
that the applications for Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated
tablets (PL 30322/0025-0028) could be approved.
These products are Prescription-Only Medicines (legal status “POM”) intended for
the treatment of:
- Major Depressive Episode
- Obsessive Compulsive Disorder
- Panic Disorder with and without agoraphobia
- Social Anxiety Disorders/Social phobia
- Generalised Anxiety Disorder
- Post-traumatic Stress Disorder
These applications were made under Article 10c of Directive 2001/83/EC, as
amended, claiming to be identical to the cross-reference products Paroxetine 10mg
Film-coated tablets (PL 19156/0134) Paroxetine 20mg Film-coated tablets (PL
19156/0135) Paroxetine 30mg Film-coated tablets (PL 19156/0136) and Paroxetine
40mg Film-coated tablets (PL 19156/0137) which were granted Market
Authorisations to Jubilant Pharmaceuticals nv on 25 June 2015.
No new non-clinical or clinical studies were conducted, which is acceptable given that
the applications are for products which are identical to products that have been
granted marketing authorisations in the UK.
The proposed manufacturing sites are consistent with those registered for the crossreference products and evidence of Good Manufacturing Practice (GMP) compliance
has been provided.
A satisfactory summary of the pharmacovigilance system has been provided with
these applications.
National Market Authorisations were granted in the UK on 2 February 2017.
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
II
QUALITY ASPECTS
LICENCE NO(S):
PL 30322/0025-0028
PROPRIETARY NAMES: Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated
tablets
ACTIVE(S):
paroxetine, paroxetine hydrochloride hemihydrate
COMPANY NAME:
Alissa Healthcare Research Limited
E.C. ARTICLE:
Article 10c of Directive 2001/83/EC, as amended
LEGAL STATUS:
Prescription-Only Medicine (POM)
II.1 INTRODUCTION
These are simple, informed consent applications for Paroxetine 10 mg, 20 mg, 30 mg
and 40 mg Film-coated tablets, submitted under Article 10c of Directive 2001/83/EC,
as amended. The proposed MA holder is Alissa Healthcare Research Limited, Unit 5,
Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, United Kingdom, PO15 7FE.
These applications cross-refer to the products Paroxetine 10mg Film-coated tablets
(PL 19156/0134), Paroxetine 20mg Film-coated tablets (PL 19156/0135), Paroxetine
30mg Film-coated tablets (PL 19156/0136) and Paroxetine 40mg Film-coated tablets
(PL 19156/0137), which were granted Market Authorisations to Jubilant
Pharmaceuticals nv on 25 June 2015.
II.2 MARKETING AUTHORISATION APPLICATION FORM
2.1 NAME(S)
The proposed names of the products are Paroxetine 10 mg Film-coated Tablets,
Paroxetine 20 mg Film-coated Tablets, Paroxetine 30 mg Film-coated Tablets and
Paroxetine 40 mg Film-coated Tablets. These products have been named in-line with
current requirements.
2.2 Strength, pharmaceutical form, route of administration, container and pack
sizes
Each film-coated tablet contains 10 mg, 20 mg, 30 mg or 40 mg of paroxetine (as
paroxetine hemihydrate). The route of administration is oral.
The finished products are packaged in white opaque polyvinylchloride/aluminium
blisters placed in cartons, in the following pack sizes:
- 10mg: 20, 28, 30, 50, 60 and 100 tablets
- 20mg: 20, 28, 30, 50, 56, 60, 100 and 250 tablets
- 30mg: 28, 30, 50, 56, 60 and 100 tablets
- 40mg: 28, 30, 50, 56, 60, 90, 100, 120 and 180 tablets
Not all pack sizes may be marketed. However, the marketing authorisation holder has
committed to submitted mock-ups of any pack size to the relevant authorities for
approval before marketing any pack size.
The proposed shelf-life is 2 years with no special storage conditions.
The proposed packaging and shelf-life are consistent with the details registered for the
cross-reference products.
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
2.3 Legal status
On approval, these products will be available as Prescription-Only Medicines (POM).
This is identical to the cross-reference products.
2.4 Marketing authorisation holder/Contact Persons/Company
Alissa Healthcare Research Limited, Unit 5, Fulcrum 1, Solent Way, Whiteley,
Fareham, Hampshire, United Kingdom, PO15 7FE.
2.5 Manufacturers
The proposed manufacturing sites are consistent with those registered for the
cross-reference products and evidence of Good Manufacturing Practice (GMP)
compliance has been provided.
2.6 Qualitative and quantitative composition
The compositions are consistent with the details registered for the cross-reference
products.
2.7 Manufacturing process
The proposed manufacturing process is consistent with the details registered for the
cross-reference products.
2.8 Finished product/shelf-life specification
The proposed finished product specifications are in-line with the details registered for
the cross-reference products.
2.9 Drug substance specification
The proposed drug substance specification is consistent with the details registered for
the cross-reference products.
2.10 TSE Compliance
No materials of animal or human origin are included in these products. This is
consistent with the cross-reference products.
II.3 EXPERT REPORTS
The applicant has included expert reports in Module 2 of the application. Signed
declarations and copies of the experts’ CVs are enclosed in Module 1.4 for the
quality, non-clinical and clinical experts. All are considered to have sufficient
experience for their responsibilities.
II.4 PRODUCT NAME & APPEARANCE
See 2.1 for details of the proposed product names. The appearances of the products
are identical to the cross-reference products.
II.5 SUMMARY OF PRODUCT CHARACTERISTICS (SmPC)
The proposed SmPCs are consistent with the details registered for the cross-reference
products.
II.7 CONCLUSIONS
The grant of marketing authorisations is recommended.
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
III
NON-CLINICAL ASPECTS
No new non-clinical data have been supplied with these applications and none are
required for applications of this type.
Since these products will be used in substitution for other products that are currently
on the market, no increase in environmental exposure is anticipated. An
Environmental Risk Assessment (ERA) is, therefore, not deemed necessary.
The grant of marketing authorisations is recommended.
IV
CLINICAL ASPECTS
No new clinical data have been supplied with these applications and none are required
for applications of this type.
The SmPCs and PIL are consistent with those of the cross-reference products.
The Marketing Authorisation Holder has provided details of a suitable
pharmacovigilance system that fulfil the requirements and provides adequate evidence
that they have the services of a qualified person responsible for pharmacovigilance,
and have the necessary means for the notification of any adverse reaction suspected of
occurring either in the Community or in a third country.
The Qualified Person (QP) responsible for pharmacovigilance is stated and their
Curriculum Vitae (CV) is included.
The Marketing Authorisation Holder 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 the use of this product. A summary of safety
concerns, as approved in the RMP, are listed below:
The grant of marketing authorisations is recommended.
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
V
USER CONSULTATION
The package leaflets have been evaluated, in accordance with the requirements of
Articles 59(3) and 61(1) of Directive 2001/83/EC, as amended. The results indicate
that the package leaflets are well-structured and organised, easy to understand and
written in a comprehensive manner. The test shows that patients/users are able to
understand and act upon the information that they contain.
VI
OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND
RECOMMENDATION
The quality of the products is acceptable, and no new non-clinical or clinical safety
concerns have been identified. These products are identical to the current granted
products Paroxetine 10mg Film-coated tablets (PL 19156/0134), Paroxetine 20mg
Film-coated tablets (PL 19156/0135), Paroxetine 30mg Film-coated tablets
(PL 19156/0136) and Paroxetine 40mg Film-coated tablets (PL 19156/0137). The
benefit/risk assessment is, therefore, considered to be positive.
In accordance with Directive 2012/84/EU, the current approved UK versions of the
SmPCs and PIL for these products are available on the MHRA website.
The current approved labels are presented below.
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
PL 30322/0025-0028
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
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UKPAR Paroxetine 10 mg, 20 mg, 30 mg and 40 mg Film-coated tablets
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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)
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