1. health and fitness
2. disease
3. allergies

UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
Sodium Cromoglicate 2% w/v Eye drops, Solution
(Sodium cromoglicate)
PL 35533/0031-0033
UKPAR
TABLE OF CONTENTS
Lay Summary
Page 2
Scientific discussion
Page 4
Steps taken for assessment
Page 12
Summary of Product Characteristics
Page 13
Patient Information Leaflet
Page 14
Labelling
Page 15
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
LAY SUMMARY
Sodium Cromoglicate 2% w/v Eye drops, Solution
(Sodium cromoglicate)
This is a summary of the Public Assessment Report (PAR) for duplicate applications
for Sodium Cromoglicate 2% w/v Eye drops, Solution (PL 35533/0031-0033). These
medicinal products will be referred to as Sodium Cromoglicate 2% w/v Eye drops,
Solution in the remainder of this report.
This summary explains how the applications for Sodium Cromoglicate 2% w/v Eye
drops, Solution were assessed and their authorisation recommended, as well as their
conditions of use. It is not intended to provide practical advice on how to use Sodium
Cromoglicate 2% w/v Eye drops, Solution.
For practical information about using Sodium Cromoglicate 2% w/v Eye drops,
Solution, patients should read the package leaflet or contact their doctor or
pharmacist.
What is Sodium Cromoglicate 2% w/v Eye drops, Solution and what is it used
for?
Sodium Cromoglicate 2% w/v Eye drops, Solution contains the active substance
sodium cromoglicate. Sodium Cromoglicate 2% w/v Eye drops, Solution is used for
the relief and treatment of eye allergies.
These duplicate medicinal products are identical to Sodium Cromoglicate 2% w/v Eye
Drops, Solution (PL 25298/0033), which was authorised to Brown & Burk UK Ltd on
29th March 2012. The company, Brown & Burk UK Ltd, has agreed that the scientific
data presented for Sodium Cromoglicate 2% w/v Eye Drops, Solution (PL
25298/0033) can be used for the applications for Sodium Cromoglicate 2% w/v Eye
drops, Solution (PL 35533/0031-0033).
How is Sodium Cromoglicate 2% w/v Eye drops, Solution used?
Sodium Cromoglicate 2% w/v Eye drops, Solution is for use as eye drops. The dosage
for adults and children over 6 years is usually 1-2 drops administered into each eye
four times daily. There is no evidence to suggest that a different dose is needed for
elderly patients. Sodium Cromoglicate 2% w/v Eye drops, Solution is not
recommended for children under 6 years of age
Sodium Cromoglicate 2% w/v Eye drops, Solution come in a bottle with a screw cap.
When using the drops for the first time, patients should ensure the tamper-proof base
ring with cap is not broken. Always wash your hands before using this medicine.
Sodium Cromoglicate 2% w/v Eye drops, Solution can be obtained from a pharmacy.
For further information on how Sodium Cromoglicate 2% w/v Eye drops, Solution is
used, please see the Summary of Product Characteristics or the package leaflet
available on the MHRA website.
How does Sodium Cromoglicate 2% w/v Eye drops, Solution work?
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
Sodium Cromoglicate Eye Drops contain a substance called sodium
cromoglicate which belongs to a group of medicines known for their anti-allergy
activity. It works by stopping the release of the natural substances in the eyes that can
lead to an allergic reaction.
How has Sodium Cromoglicate 2% w/v Eye drops, Solution been studied?
Sodium Cromoglicate 2% w/v Eye drops, Solution is a duplicate of the previously
granted application for Sodium Cromoglicate 2% w/v Eye Drops, Solution (PL
25298/0033; Brown & Burk UK Ltd). The company referred to data provided by
Brown & Burk UK Ltd for the grant of a licence for Sodium Cromoglicate 2% w/v
Eye Drops, Solution (PL 25298/0033) as the basis for the grant of licences for Sodium
Cromoglicate 2% w/v Eye drops, Solution (PL 35533/0031-0033).
What are the benefits and risks of Sodium Cromoglicate 2% w/v Eye drops,
Solution?
As Sodium Cromoglicate 2% w/v Eye drops, Solution (PL 35533/0031-0033) are
considered identical to Sodium Cromoglicate 2% w/v Eye Drops, Solution (PL
25298/0033), its benefits and risks are taken as being the same as those for Sodium
Cromoglicate 2% w/v Eye Drops, Solution (PL 25298/0033)
Why is Sodium Cromoglicate 2% w/v Eye drops, Solution approved?
No new or unexpected safety concerns arose from these duplicate applications. It was,
therefore, considered that the benefits of Sodium Cromoglicate 2% w/v Eye drops,
Solution outweigh the identified risks; and the grant of Marketing Authorisations was
recommended.
What measures are being taken to ensure the safe and effective use of Sodium
Cromoglicate 2% w/v Eye drops, Solution?
A risk management plan has been developed to ensure that Sodium Cromoglicate 2%
w/v Eye drops, Solution 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 Sodium Cromoglicate 2% w/v Eye drops, Solution, including the
appropriate precautions to be followed by healthcare professionals and patients.
Other information about Sodium Cromoglicate 2% w/v Eye drops, Solution
Marketing Authorisations were granted in the UK on 22nd August 2014.
For more information about taking Sodium Cromoglicate 2% w/v Eye drops,
Solution, read the package leaflet, or contact your doctor or pharmacist.
This summary was last updated in October 2014.
The full PAR for Sodium Cromoglicate 2% w/v Eye drops, Solution follows this
summary.
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
Sodium Cromoglicate 2% w/v Eye drops, Solution
(Sodium cromoglicate)
PL 35533/0031-0033
SCIENTIFIC DISCUSSION
TABLE OF CONTENTS
Introduction
Page 5
Pharmaceutical assessment
Page 6
Non-clinical assessment
Page 9
Clinical assessment
Page 10
Overall conclusion and benefit/risk assessment
Page 11
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
INTRODUCTION
The Medicines and Healthcare products Regulatory Agency (MHRA) granted Aspire
Pharma Limited Marketing Authorisations for the medicinal products Sodium
Cromoglicate 2% w/v Eye drops, Solution (PL 35533/0031-0033) on 22nd August
2014. These pharmacy (P) medicines are used for the relief and treatment of seasonal
and perennial allergic conjunctivitis. These products will be referred to as Sodium
Cromoglicate 2% w/v Eye drops, Solution throughout this report.
These duplicate applications were submitted as simple applications according to
Article 10c of Directive 2001/83/EC, as amended. The applicant has cross-referred to
Sodium Cromoglicate 2% w/v Eye Drops, Solution (PL 25298/0033), which was
authorised to Brown & Burk UK Ltd on 29th March 2012.
No new data were submitted nor were they necessary for these simple applications, as
the data are identical to those of the previously granted cross-reference product.
The MHRA has been assured that acceptable standards of Good Manufacturing
Practice (GMP) are in place for these product types at all sites responsible for the
manufacture and assembly of these products.
A summary of the pharmacovigilance system and a detailed risk management plan
have been provided with these applications and these are satisfactory.
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
PHARMACEUTICAL ASSESSMENT
LICENCE NO: PL 35533/0031-0033
PROPRIETARY NAME: Sodium Cromoglicate 2% w/v Eye drops, Solution
COMPANY NAME: Aspire Pharma Limited
E.C. ARTICLE: Article 10c of Directive 2001/83/EC, as amended
LEGAL STATUS: P
1
INTRODUCTION
These are informed consent applications for Sodium Cromoglicate 2% w/v Eye drops,
Solution, submitted under Article 10c of Directive 2001/83/EC, as amended. The
applicant has cross-referred to Sodium Cromoglicate 2% w/v Eye Drops, Solution
which was authorised to Brown & Burk UK Ltd on 29th March 2012. The current
applications are considered valid.
2
MARKETING AUTHORISATION APPLICATION (MAA)
2.1 Name(s)
The proposed name of the products is Sodium Cromoglicate 2% w/v Eye drops,
Solution. The products have been named in line with current requirements.
2.2 Strength, pharmaceutical form, route of administration, container and pack
sizes
These products are eye drop solutions and contain 2% w/v sodium cromoglicate.
The solution is packed in a low density polyethylene (LDPE) blow fill seal (BFS)
container with white polypropylene spiked screw cap having a tamper-proof base ring
containing 5 ml and 10 ml.
Not all pack sizes may be marketed.
Specifications and Certificates of Analysis for all packaging components used have
been provided and are satisfactory. The packaging and pack sizes are the same as
those for the cross-reference product.
The proposed shelf-lives are 30 months for unopened bottle with no special storage
conditions, and 4 weeks after opening with a storage condition ‘Do not store above
25°C’.
The shelf-lives and storage conditions are identical to those for the cross-reference
product and are satisfactory.
2.3 Legal status
Sodium Cromoglicate 2% w/v Eye drops, Solution is supplied through a pharmacy
(P).
2.4 Marketing Authorisation Holder/Contact Persons/Company
The proposed Marketing Authorisation holder is Aspire Pharma Limited, Bellamy
House, Winton Road, Petersfield, Hampshire, GU32 3HA, United Kingdom
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
2.5 Manufacturers
The proposed manufacturing sites are consistent with those registered for the crossreference product and evidence of Good Manufacturing Practice (GMP) compliance
has been provided.
2.6 Qualitative and quantitative composition
The proposed formula is consistent with the details registered for the cross-reference
product.
2.7 Manufacturing processes
The proposed manufacturing processes are consistent with the details registered for
the cross-reference product and the maximum full scale batch size is stated.
2.8 Finished product specifications
The proposed finished product specifications, at release and shelf-life, are in line with
the details registered for the cross-reference product.
2.9 Drug substance specification
The proposed drug substance specification conforms to the current European
Pharmacopoeia monograph for sodium cromoglicate and is in line with that for the
cross-reference product.
A European Directorate for the Quality of Medicines and Healthcare (EDQM)
Certificate of Suitability for the manufacture of sodium cromoglicate has been
provided. The active substance manufacturer is the same as the manufacturer
approved for the cross-reference product.
2.10 TSE Compliance
No materials of animal or human origin are included in these products. This is
consistent with the cross-reference product.
2.11 Bioequivalence
No bioequivalence data are required to support these informed consent applications,
as the proposed products are manufactured to the same formula utilising the same
process as the cross-reference product, Sodium Cromoglicate 2% w/v Eye Drops,
Solution (PL 25298/0033).
3
EXPERT REPORTS
The applicant has cross-referred to the data for cross-reference product, Sodium
Cromoglicate 2% w/v Eye Drops, Solution (PL 25298/0033), to which they are
claimed to be identical. This is acceptable. The applicant has included detailed expert
reports for the application. Signed declarations and copies of the experts’ CVs are
enclosed for the quality, non-clinical and clinical experts. All are considered to have
sufficient experience for their responsibilities.
4.
PRODUCT NAME & APPEARANCE
See 2.1 for details of the proposed product name. The appearance of the products is
identical to that of the cross-reference product.
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
5.
PL 35533/0031-0033
SUMMARIES OF PRODUCT CHARACTERISTICS (SmPCs)
The proposed SmPCs are consistent with the details registered for the cross-reference
product.
6.
PATIENT INFORMATION LEAFLET (PIL)/LABELLING
The package leaflet is identical to the leaflet for the reference product. A satisfactory
user testing has been provided.
The proposed artwork complies with the relevant statutory requirements. In line with
current legislation the applicant has also included the name of the product in Braille
on the outer packaging and sufficient space for a standard UK pharmacy dispensing
label.
7.
CONCLUSION
The data submitted with the applications are acceptable. The grant of Marketing
Authorisations is recommended.
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
NON-CLINICAL ASSESSMENT
No new non-clinical data have been supplied with these applications and none are
required for applications of this type.
A satisfactory justification has been provided for not submitting an environmental risk
assessment (ERA).
9
UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
CLINICAL ASSESSMENT
No new clinical data have been supplied with these applications and none are required
for applications of this type.
10
UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT
QUALITY
The data for these applications are consistent with those previously assessed for the
cross-reference product and, as such, have been judged to be satisfactory.
NON-CLINICAL
No new non-clinical data were submitted and none are required for applications of
this type.
CLINICAL
These applications are identical to the previously granted application for Sodium
Cromoglicate 2% w/v Eye Drops, Solution (PL 25298/0033), authorised to Brown &
Burk UK Ltd on 29th March 2012.
No new or unexpected safety concerns arose from these applications.
The SmPCs, PIL and labelling are satisfactory and consistent with those for the crossreference product.
BENEFIT RISK ASSESSMENT
The quality of the products is acceptable and no new non-clinical or clinical concerns
have been identified. The applicant’s products are identical to the cross-reference
product. Extensive clinical experience with sodium cromoglicate is considered to have
demonstrated the therapeutic value of the compound. The benefit risk is, therefore,
considered to be positive.
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
Sodium Cromoglicate 2% w/v Eye drops, Solution
(Sodium cromoglicate)
PL 35533/0031-0033
STEPS TAKEN FOR ASSESSMENT
1
The MHRA received the Marketing Authorisation applications on 25th June
2013
2
Following standard checks and communication with the applicant the MHRA
considered the applications valid on 4th July 2013
3
Following assessment of the applications the MHRA requested further
information on 17th September 2013, 15th November 2013, 20th February 2014
and 2nd April 2014
4
The applicant responded to the MHRA’s request, providing further information
on 25th October 2013, 25th January 2014, 26th March 2014 and 16th June 2014
5
The applications were determined on 22nd August 2014
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
SUMMARY OF PRODUCT CHARACTERISTICS
In accordance with Directive 2010/84/EU the Summaries of Product Characteristics
(SmPCs) for products that have been granted Marketing Authorisations at a national
level are available on the MHRA website.
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
PATIENT INFORMATION LEAFLET
In accordance with Directive 2010/84/EU the Patient Information Leaflets (PILs) for
products that have been granted Marketing Authorisations at a national level are
available on the MHRA website.
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
LABELLING
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
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PL 35533/0031-0033
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
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PL 35533/0031-0033
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UKPAR Sodium Cromoglicate 2% w/v Eye drops, Solution
PL 35533/0031-0033
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PL 35533/0031-0033
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PL 35533/0031-0033
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PL 35533/0031-0033
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