Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Virbagest 4 mg/ml
MODULE 1
PRODUCT SUMMARY
| EU Procedure number | UK/V/0237/001/DC |
| Name, strength and pharmaceutical form | Virbagest 0.4mg/ml Oral Solution for Pigs |
| Applicant | Virbac S.A. |
| Active substance | Altrenogest |
| ATC Vetcode | QG03DX90 |
| Target species | Pigs |
| Indication for use | For the synchronisation of oestrus in nulliparous mature sows |
MODULE 2
The Summary of Product Characteristics (SPC) for this product is available on the Heads of Medicines Agencies (veterinary) (HMA(v)) website.
MODULE 3
PUBLIC ASSESSMENT REPORT
| Legal basis of original application | Decentralised application in accordance with Article 13(1) of Directive 2001/82/EC as amended. |
| Date of completion of the original decentralised procedure | 27 September 2007 |
| Date product first authorised in the Reference Member State (MRP only) | n/a |
| Concerned Member States for original procedure | Belgium Czech Republic France Germany Hungary Poland Spain |
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I. SCIENTIFIC OVERVIEW
The product is produced and controlled using validated methods and tests which ensure the consistency of the product released on the market. It has been shown that the product can be safely used in the target species. The product is safe for the user, the consumer of foodstuffs from treated animals and for the environment, when used as recommended. Suitable warnings and precautions are indicated in the SPC. The efficacy of the product was demonstrated according to the claims made in the SPC. The overall risk/benefit analysis is in favour of granting a marketing authorisation.
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II. QUALITY ASPECTS
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A. Composition
The product contains the active substance altrenogest and excipients butylated hydroxytoluene, butylated hydroxyanisole and soya-bean oil refined.
The container/closure system comprises a polyethylene terephthalate bottle with an unremovable plastic shell clipped to the bottle, containing 450 ml or 900 ml of product. The bottle is hermetically closed with child proof screw cap. The particulars of the containers and controls performed are provided and conform to the regulation.
The choice of the formulation is justified.
The product is an established pharmaceutical form and its development is adequately described in accordance with the relevant European guidelines.
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B. Method of Preparation of the Product
The product is manufactured fully in accordance with the principles of good manufacturing practice from a licensed manufacturing site.
Process validation data on the product have been presented in accordance with the relevant European guidelines.
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C. Control of Starting Materials
The active substance is altrenogest. Supporting data have been provided in the form of an Active Substance Master File (ASMF). It is considered that the manufacturing process is adequately controlled and the active substance specification has been suitably justified.
The active substance specification is considered adequate to control the quality of the material. Batch analytical data demonstrating compliance with this specification have been provided.
All the other substances in the tablets comply with the requirements of the relevant European Pharmacopoeial monographs.
A certificate of conformity is provided for the polyethylene terephthalate stating that it complies with monograph 3.1.15 of the European Pharmacopoeia for “Polyethylene terephthalate for containers for preparations not for parental use”.
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D. Specific Measures concerning the Prevention of the Transmission
of Animal Spongiform Encephalopathies
There are no substances within the scope of the TSE Guideline present or used in the manufacture of this product.
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E. Control on intermediate products
There are no intermediate products.
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F. Control Tests on the Finished Product
The finished product specification controls the relevant parameters for the pharmaceutical form. The tests in the specification, and their limits, have been justified and are considered appropriate to adequately control the quality of the product.
Satisfactory validation data for the analytical methods have been provided.
Batch analytical data from the proposed production site have been provided demonstrating compliance with the specification.
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G. Stability
Stability data on the active substance was discussed in the DMF in accordance with applicable European guidelines, demonstrating the stability of the active substance when stored under the approved conditions.
Stability data on the finished product have been provided in accordance with applicable European guidelines, demonstrating the stability of the active substance when stored under the approved conditions.
Stability data on the finished product have been provided in accordance with applicable European guidelines, demonstrating the stability of the product throughout its shelf life when stored under the approved conditions.
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H. Genetically Modified Organisms
Not applicable
J. Other Information
Shelf-life of the veterinary medicinal product as packaged for sale: 36 months.
Shelf-life after first opening the immediate packaging: 60 days.
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III. SAFETY AND RESIDUES ASSESSMENT (PHARMACOTOXICOLOGICAL)
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III.A Safety Testing
Pharmacological Studies
As this is a generic application according to Article 13, and bioequivalence with a reference product has been demonstrated, results of pharmacological tests are not required.
The pharmacological aspects of this product are identical to the reference product.
Warnings and precautions as listed on the product literature are the same as those of the reference product and are adequate to ensure safety of the product to users / the environment / consumers
Toxicological Studies
As this is a generic application according to Article 13, and bioequivalence with a reference product has been demonstrated, results of toxicological tests are not required.
The toxicological aspects of this product are identical to the reference product.
Warnings and precautions as listed on the product literature are the same as those of the reference product and are adequate to ensure safety of the product to users / the environment / consumers
User Safety
As this is a generic application according to Article 13, and bioequivalence with a reference product has been demonstrated, user safety data are not required.
The user safety aspects of this product are identical to the reference product.
Warnings and precautions as listed on the product literature are the same as those of the reference product and are adequate to ensure safety of the product to users / the environment / consumers
Ecotoxicity
The applicant provided a environmental risk assessment that was considered to be acceptable for demonstration of the environmental safety of the product which showed that no further assessment is required. Warnings and precautions as listed on the product literature are adequate to ensure safety to the environment when the product is used as directed.
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III.B Residues documentation
Residue Studies
No residue depletion studies were conducted because this is a generic application according to Article 13, and bioequivalence with a reference product has been demonstrated.
Withdrawal Periods
A withdrawal period of 24 days for meat in pigs is justified. This is the same as the reference product.
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IV CLINICAL ASSESSMENT (EFFICACY)
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IV.A Pre-Clinical Studies
Pharmacology
The application is made in accordance with Article 13 (1) of Directive
2001/82/EC as amended by Directive 2004/28/EC, on the basis of being a generic of a reference medicinal product, no further information is required as it has already been presented for the reference product. Bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.
Tolerance in the Target Species of Animals
The application is made in accordance with Article 13 (1) of Directive
2001/82/EC as amended by Directive 2004/28/EC, on the basis of being a generic of a reference medicinal product, no further information is required as it has already been presented for the reference product. Bioequivalence with the
reference medicinal product has been demonstrated by appropriate bioavailability studies.
The product literature accurately reflects the type and incidence of adverse effects which might be expected.
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IV.B Clinical Studies
The application is made in accordance with Article 13 (1) of Directive 2001/82/EC as amended by Directive 2004/28/EC, on the basis of being a generic of a reference medicinal product, no further information is required as it has already been presented for the reference product. Bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.
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V OVERALL CONCLUSION AND BENEFIT– RISK ASSESSMENT
MODULE 4
POST-AUTHORISATION ASSESSMENTS
The SPC and package leaflet may be updated to include new information on the quality, safety and efficacy of the veterinary medicinal product. The current SPC is available on the Heads of Medicines Agencies (veterinary) (HMA(v)) website.
This section contains information on significant changes which have been made after the original procedure which are important for the quality, safety or efficacy of the product.
None
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