Beipackzettel - Luminaletten vet 15 mg Tabletten für Hunde
MODULE 1
PRODUCT SUMMARY
| EU Procedure number | DE/V/0141/001/DC |
| Name, strength and pharmaceutical form | Luminaletten vet, 15 mg , Tablets |
| Applicant | Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg, Germany |
| Active substance(s) | Phenobarbital |
| ATC Vetcode | QN03AA02 |
| Target species | Dog |
| Indication for use | Treatment of idiopathic generalised epilepsy in dogs. |
MODULE 2
The Summary of Product Characteristics (SPC) for this product is available on the Heads of Veterinary Medicinal Agencies website.
MODULE 3
PUBLIC ASSESSMENT REPORT
| Legal basis of original application | Application in accordance with Article 32 of Directive 2001/82/EC as amended. |
| Date of completion of the original Decentralised procedure | 29 September 2010 |
| Date product first authorised in the Reference Member State (MRP only) | n.a. |
| Concerned Member States for original procedure | AT, BE, DK, ES, FR, NL, PT, SE |
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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 slight reactions observed are indicated in the SPC.
The product is safe for the user, 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 15 mg phenobarbital per tablet and the excipients microcrystalline cellulose, maize starch, gelatin, lactose monohydrate and stearic acid (50).
Container/closure system:
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a) Brown glass containers, packed in a folding carton. Each bottle is closed with a child-resistant polyethylene stopper with bolt and bellow.
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b) Plastic containers (HDPE), closed with a child resistant polypropylene screw cap and packed in a folding carton.
The particulars of the containers and controls performed are provided and conform to the regulation.
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 phenobarbital, an established active substance described in the European Pharmacopoeia. The active substance is manufactured in accordance with the principles of good manufacturing practice.
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.
There are no substances within the scope of the TSE Guideline present or used in the manufacture of this product.
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D. Control on intermediate products
The tests performed during production are described and the results, conforming to the specifications, are provided.
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E. 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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F. Stability
Stability data on the active substance 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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III. SAFETY AND RESIDUES ASSESSMENT (PHARMACOTOXICOLOGICAL)
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III. A Safety Testing
Pharmacological Studies
The applicant has provided bibliographical data which show that phenobarbital acts centrally by affecting the inhibitory neurotransmitter gamma-aminobutyric acid system.
The applicant has provided bibliographical data which show that phenobarbital is well absorbed from the gastrointestinal tract following oral administration and crosses the blood-brain barrier.
Toxicological Studies
The applicant has provided bibliographical data which show that the toxicity of Phenobarbital is well established and extensively reported.
- Single Dose Toxicity
LD50 values in rat, mouse, dog, rabbit and guinea pig range between 88 mg/kg i.p. in mouse and 284 mg/kg rectal in rat. The LD50 value in dogs after oral use is 150 mg/kg. Adverse effects which can be observed are mainly neurogenic.
- Repeated Dose Toxicity
Adverse effects reported after feeding studies or intraperitoneal administration in rodents included hepatomegaly, increased liver weight and biochemical or blood changes (e. g. induction of liver enzymes).
- Reproductive Toxicity, including Teratogenicity:
Phenobarbital is a teratogen and can produce permanent alterations in sexual maturation and may lead to sexual dysfunction in later life if used during prenatal development.
- Mutagenicity
Phenobarbital is considered to be a weak mutagen.
- Carcinogenicity (if necessary):
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 Veterinary Medicinal Agencies 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.
Quality changes
| Summary of change (Application number) | Section updated in Module 3 | Approval date |
| Change in the (invented) name of the medicinal product (DE/V/0141/IB/005/G) | Module 1 | 9 August 2013 |
| Change in the immediate packaging of the finished product (addition of new container) (DE/V/0141/IB/006/G) | 3.2.P.7 3.2.P.8 | 29 May 2015 |
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