Beipackzettel - Rimifin Flavour 50 mg Tabletten für Hunde
MODULE 2
The Summary of Product Characteristics (SPC) for this product is available on the veterinary Heads of Agencies website.
MODULE 3
PUBLIC ASSESSMENT REPORT
| Legal basis of original application | An essentially similar application in accordance with Article 13.1 (a) (iii) as of Directive 2001/82/EC as amended. |
| Date of completion of the original mutual recognition procedure | 27th September 2006 |
| Date product first authorised in the Reference Member State (MRP only) | 3rd March 2006 |
| Concerned Member States for original procedure | AT, CZ, DK, EE, EL, ES FI, FR, HU, IS, LV, LT, NO, PL, SE, NL |
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I. SCIENTIFIC OVERVIEW
For public assessment reports for the first authorisation in a range :
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
- A.1 Composition of the Veterinary Medicinal Product
Active Substance : Carprofen (20 mg, 50 mg and 100mg)
Excipients : Lactose monohydrate
Microcrystalline cellulose
Colloidal silicon dioxide
Magnesium stearate
A.2 Container/Closure System
- White HDPE twist-off plastic container with child proof tamper evident polypropylene white twist off closures
- Blister packs made up of a PVC/PVdC (250 Um/40g/m2) with a 20 mu Hard Temper Aluminium Foil
- A.3 Clinical Trial Formula(e)
The formulation of the batch used in key clinical studies is identical to that proposed for marketing.
- A.4 Development Pharmaceutics
The product is an established pharmaceutical form and its development is adequately described in accordance with the relevant European guidelines.
B Method of Preparation of the Product
- B.1 Manufacturing Formula
This information is commercially confidential.
- B.2 Method of Preparation
The product is manufactured fully in accordance with the principles of good manufacturing practice from a licensed manufacturing site.
- B.3 Validation of the Manufacturing Process
Process validation data on the product have been presented in accordance with the relevant European guidelines.
C Control of Starting Materials
- C.1 Active Substance
The active substance is Carprofen, an established active substance.
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.
- C.2 Other Substance(s)
Other substances in the product comply with relevant European Pharmacopoeia monographs.
- C.3 Packaging Materials
- The product is packaged in white HDPE twist-off plastic containers and blister packs.
The packaging materials comply with relevant EU standards.
D Specific Measures concerning the Prevention of the Transmission
of Animal Spongiform Encephalopathies
Scientific data have been provided and compliance with the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products has been satisfactorily demonstrated.
E Intermediate Products
Not applicable.
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.
G Stability
- G.1 Stability Studies on the Active Substance
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.
- G.2 Stability Tests on the Finished Product
Stability data on the 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.
H Other Information
None.
Conclusion on Quality
The manufacture of the product is adequately described and controlled. Testing methods and specifications for the raw materials and packaging components are acceptable. The control tests and specifications for the finished product are appropriate. The shelf life and storage conditions are supported by appropriate stability data.
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III. SAFETY AND RESIDUES ASSESSMENT (PHARMACOTOXICOLOGICAL) ( for pharmaceuticals only)
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III.A Safety Testing
The application is made in accordance with Article 13(a)(iii) of Directive 2001/82/EC, on the basis of essential similarity.
Comparative pharmacokinetic data provided in support of the application show that the test product (Rimifin Tablets) is bioequivalent to the reference product (Rimadyl Tablets, VPA 10019/63/1–3); consequently, it can be concluded that the systemic effects of the two products in respect of safety and efficacy will be the same. To further support the safety of the final formulation, the Applicant has provided the results of a study that clearly demonstrates that the product is well tolerated in juvenile dogs when administered at up to 3 times the recommended treatment dose for 14 days. The proposed SPC for Rimifin reflects the authorised SPC of the reference product in Ireland.
In respect of user safety, the most likely route of human exposure to carprofen is through the skin or by deliberate ingestion. However, when the product is used in accordance with label recommendations the product is unlikely to result in toxicity. No specific user warnings are proposed.
The product is not expected to pose a hazard to the environment.
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III.B Residues documentation
Not applicable.
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IV. CLINICAL ASSESSMENT (EFFICACY)
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 veterinary Heads of 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.
There have been no significant post-authorisation assessments.
CMD(v)/TEM/003–00
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