PASSIFLORA Herb Capsules - Medicines and Healthcare products

Transcription

PASSIFLORA Herb Capsules
THR 00904/0001
UKPAR
TABLE OF CONTENTS
Lay summary
Page 2
Scientific discussion
Page 3
Steps taken for assessment
Page 10
Summary of Product Characteristics
Page 11
Product Information Leaflet
Page 14
Labelling
Page 17
MHRA PAR; PASSIFLORA HERB CAPSULES, THR 00904/0001
1
PASSIFLORA HERB CAPSULES
THR 00904/0001
LAY SUMMARY
The Medicines and Healthcare products Regulatory Agency (MHRA) granted Kerbina
Limited a Traditional Herbal Registration Certificate for the traditional herbal
medicinal product PASSIFLORA Herb Capsules (Traditional Herbal Registration
number: THR 00904/0001). This product is available without prescription and can be
bought from pharmacies and other outlets.
PASSIFLORA Herb Capsules is a traditional herbal medicinal product used for the
temporary relief of mild anxiety and to aid sleep. The active ingredient in
PASSIFLORA Herb Capsules comes from the herb of the Passion Flower plant,
which is also known as Passiflora incarnata L.
This registration is based exclusively upon evidence of the use of Passion Flower herb
as a traditional herbal medicine and not upon data generated from clinical trials. There
is no requirement under the Traditional Herbal Registration (THR) Scheme to prove
scientifically that the product works.
No new or unexpected safety concerns arose from this application and it was,
therefore, decided that a THR Certificate could be granted.
2
THR 00904/0001
SCIENTIFIC DISCUSSION
TABLE OF CONTENTS
Introduction
Page 4
Pharmaceutical assessment
Page 5
Preclinical assessment
Page 7
Clinical assessment
Page 8
Overall conclusions and risk assessment
Page 9
3
INTRODUCTION
The MHRA granted a THR Certificate for the traditional herbal medicinal product
PASSIFLORA Herb Capsules (THR 00904/001) to Kerbina Limited on 5 August
2011. This product is on the general sales list (GSL).
A Marketing Authorisation (Product Licence) was granted to Kerbina Limited for this
product on 28 April 1988 (PL 00904/5045R). Confirmation is given that PL
00904/5045R will be cancelled after the THR is granted.
This THR application was made under Article 16.c of Directive 2001/83 EC in
accordance with arrangements to transfer certain herbal products with a Marketing
Authorisation to a THR (according to MHRA Guidance dated January 2009). The
application falls within the simplified THR application Category A, as no significant
changes have been made to the formulation of the product. No new data were
submitted, nor was it necessary for this application, as the data are essentially
identical to those of the existing product.
4
PHARMACEUTICAL ASSESSMENT
HERBAL SUBSTANCE
(PREPARATION):
PASSION FLOWER HERB
Scientific name of the plant: Passiflora incarnata L.
Family:
Passifloraceae
The herbal substance complies with the Ph. Eur. monograph, it is, therefore,
acceptable.
In this product the herbal substance and herbal preparation is the same thing, as no
processing of the herbal substance is carried out prior to it being used to make the
herbal product.
HERBAL PRODUCT:
Description and Composition of the Herbal Product
The product comprises 300 mg of Passion Flower herb enclosed in a clear, size 0,
hard hypromellose capsule. The product formulation is similar to that of the already
licensed product. It is, therefore, acceptable.
Manufacture
The manufacturing process is in line with that of the already licensed product and is
satisfactory.
Finished Product Specification
The finished product specification is in line with that of the already licensed product
and is satisfactory.
Container Closure System
The capsules are stored in Duma 110ml HDPE plastic containers with a tamper
evident threaded Duma cap. Each pack contains 60 capsules. This type of packaging
has been used to store the already licensed product and is satisfactory.
Stability
The product shelf-life of 3 years was applied to the already licensed product and is
appropriate when the storage precautions ‘Store below 25°C’ and ‘Store in the
original package’ are applied.
Summary of Product Characteristics, labelling and Patient Information Leaflet
All product literature is in line with that of the already licensed product, with some
details amended in line with other products containing Passion Flower herb that are
registered under the THR scheme.
A package leaflet has been submitted to the MHRA along with results of consultations
with target patient groups ("user testing"), in accordance with Article 59 of Council
Directive 2001/83/EC. The results indicate that the package leaflet is well-structured
5
and organised, easy to understand and written in a comprehensive manner. The test
shows that the patients/users are able to act upon the information that it contains.
ASSESSOR’S OVERALL CONCLUSION
It is recommended that a THR can be granted.
6
PRECLINICAL ASSESSMENT
INTRODUCTION
No new preclinical data have been supplied with this application and none are
required for an application of this type.
Assurance has been given that the results of genotoxicity testing will be provided by
the renewal date of the THR.
PRODUCT LITERATURE
All product literature is satisfactory from a preclinical point of view.
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CLINICAL ASSESSMENT
INTRODUCTION
The clinical particulars for PASSIFLORA Herb Capsules are in line with those for the
already licensed product. This is satisfactory.
PRODUCT LITERATURE
All product literature is medically satisfactory.
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OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT
QUALITY
PASSIFLORA Herb Capsules are identical to an already licensed product. They are,
therefore, pharmaceutically satisfactory.
PRECLINICAL
No new preclinical data were submitted and none are required for an application of
this type. The results of genotoxicity testing will be provided before the THR is
renewed.
EFFICACY
No clinical efficacy data are required for registration of traditional herbal medicinal
products.
SAFETY
No new or unexpected safety concerns arose from this application.
BENEFIT-RISK ASSESSMENT
The quality of the product is acceptable and no new preclinical or clinical safety
concerns have been identified. The benefit: risk balance is acceptable and a THR
should be granted.
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THR 00904/0001
STEPS TAKEN FOR ASSESSMENT
1
The MHRA received the THR application on 4 February 2011
2
Following standard checks and communication with the applicant the
MHRA considered the application valid on 28 February 2011
3
Following assessment of the application the MHRA requested further
information relating to the dossier on 9 May 2011
4
The applicant responded to the MHRA’s requests, providing further
information on the dossier on 4 August 2011
5
A THR was granted on 5 August 2011
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PASSIFLORA Herb Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300mg of Passion Flower herb (Passiflora incarnata
L.)
For list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsules.
Clear size 0 hard capsules.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
PASSIFLORA Herb is a traditional herbal medicinal product used for the
temporary relief of mild anxiety and to aid sleep, based on traditional use only.
4.2
Posology and method of administration
For oral, short term use only use only.
For adults and the elderly.
For the temporary relief of symptoms of mild anxiety take 1-2 capsules 3
times a day.
To aid sleep, take 2 capsules 30 minutes before bedtime with an earlier dose of
2 capsules earlier in the evening if necessary.
Swallow the capsules with a glass of water.
Maximum daily dose: 8 single doses
Duration of use:If symptoms persist, worsen or do not improve after 4 weeks during the use of
the product, a doctor or a qualified healthcare care practitioner should be
consulted.
The use of this product in children and adolescents under 18 years of age is not
recommended (see section 4.4 Special warnings and precautions for use).
4.3
Contraindications
Hypersensitivity to Passion Flower or any of the excipients.
4.4
Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms persist, worsen or do not improve after 4 weeks during the use of
the product, a doctor or a qualified healthcare practitioner should be consulted.
The use of the product in children and adolescents under 18 years of age is not
recommended as data is not sufficient and medical advice should be sought.
11
4.5
Interaction with other medicinal products and other forms of interaction
Concomitant use with synthetic sedatives such as benzodiazepines is not
recommended unless advised by a doctor.
4.6
Fertility, pregnancy and lactation
The safety of the product during pregnancy and lactation has not been
established. In the absence of sufficient data, the use during pregnancy and
lactation is not recommended.
Tests on the effects on fertility have not been performed.
4.7
Effects on ability to drive and use machines
The product may impair the ability to drive ands use machines.
Affected patients should not drive or operate machinery.
4.8
Undesirable effects
One case of hypersensitivity (vasculitis) and one case of nausea and
tachycardia have been reported.
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified
health care practitioner should be consulted.
4.9
Overdose
No case of overdose has been reported. Symptomatic and supportive measures
should be taken as appropriate.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as
amended.
5.2
Pharmacokinetic properties
Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as
amended.
5.3
Preclinical safety data
Test on reproductive toxicity, genotoxicity and carcinogenicity have not been
performed.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Hypromellose (capsule shell)
6.2
Incompatibilities
Not Applicable.
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6.3
Shelf life
3 years.
6.4
Special precautions for storage
Store below 25°C. Store in the original package.
6.5
Nature and contents of container
Duma 110ml HDPE plastic container and tamper evident threaded Duma cap.
PASSIFLORA pack contains 60 Capsules.
6.6
Special precautions for disposal
There are no special precautions for disposal of PASSIFLORA capsules.
When the container is empty the label should be removed and the container
placed in a recycling bin.
7
MARKETING AUTHORISATION HOLDER
Kerbina Limited,
Trading as:
Bio-Health Limited
Culpeper Close
Medway City Estate
Rochester
Kent
ME2 4HU
8
MARKETING AUTHORISATION NUMBER(S)
THR 00904/001
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05/08/2011
10
DATE OF REVISION OF THE TEXT
05/08/2011
13
PRODUCT INFORMATION LEAFLET
14
15
16
LABELLING
17

PASSIFLORA Herb Capsules - Medicines and Healthcare products

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