Vm 40630/4000

MEMORANDUM DOCUMENT

THE VETERINARY MEDICINES REGULATIONS
Marketing Authorisation No: / Vm 40630/4000
Product Name: / Allevinix 50 mg/ml Solution for Injection for Cattle, Pigs and Horses
Granted to: / Coophavet
23, Rue du Prieuré
Saint Herblon
44150 Ancenis
France

The information detailed in this document has been extracted from the documents and particulars submitted to the Veterinary Medicines Directorate in accordance with the requirements of the Veterinary Medicines Regulations.

This document does not form part of the Marketing Authorisation but is an administrative aid to help ensure that the authorisation has been given in the terms requested in the application as amended. It should be read in conjunction with the draft Summary of Product Characteristics (SPC).

Please advise the VMD immediately if you do not agree with any of the details on this document or the draft SPC.

1. LEGAL CATEGORY

Prescription Only Medicine – Veterinarians: A veterinary medicinal product classified as POM-V may only be supplied in accordance with a prescription from a veterinary surgeon following a clinical assessment of the animal or group of animals.

POM-V


2. COMPOSITION

Active substance / Grade / mg/ml
Flunixin / 50.0
(as Flunixin meglumine / Ph. Eur. / 83.0)
Other substances
Phenol / Ph. Eur. / 5.0
Sodium Formaldehyde Sulphoxylate Dihydrate / USPNF / 2.5
Disodium edetate dihydrate / Ph. Eur. / 0.1
Diethanolamine / USPNF / 4.0
Propylene glycol / Ph. Eur. / 207.2
Hydrochloric acid, dilute / Ph. Eur. / to pH 8.5
Water for injections / Ph. Eur. / to 1.0 ml
Overages
None
Note:
The MA Memorandum summarises information contained in the product dossier. The title used for an ingredient recorded in the MA Memorandum is not necessarily that currently used in the European or other pharmacopoeia. To avoid the need to issue updated documents reflecting changes in, or additions to, the pharmacopoeia, the VMD employs its own standardised title.


3. PACK DETAILS A

(i) / Size: / 50 ml*, 100 ml and 250 ml
(ii) / Container: / Clear, colourless Type II glass vials
(iii) / Closure: / Type I, chlorobutyl rubber stoppers and a flip-off cap on top of an aluminium crimp seal
(iv) / Dosing device: / Not specified
(v) / Secondary pack: / Carton

*Not currently marketed.

PACK DETAILS B

(i) / Size: / 50 ml*, 100 ml and 250 ml
(ii) / Container: / Colourless polyethylene terephthalate vials
(iii) / Closure: / Type I, clorobutyl rubber stoppers and a flip-off cap on top of an aluminium crimp seal
(iv) / Dosing device: / Not specified
(v) / Secondary pack: / Carton

*Not currently marketed.

4. MANUFACTURERS OF ACTIVE SUBSTANCE

(i) / Excella GmbH
Nürnberger Str. 12
90537 Feucht
Germany
In accordance with Ph.Eur. Certificate of Suitability R1-CEP2006-049-Rev 00
(ii) / Zhejiang Hisoar Pharmaceutical Co. Ltd.
No. 100 Waisha Branch Road
Jiaojiang District
318000 Taizhou
Zhejiang Province
China
In accordance with Ph. Eur. Certificate of Suitability R0-CEP 2007-108-Rev 01

5. INGREDIENTS OF RUMINANT ORIGIN

Format 3
No materials within scope
In accordance with Section 2 of the CPMP/CVMP Note for Guidance for Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Veterinary Medicinal Products (EMEA/410/01).

6. MANUFACTURERS OF DOSAGE FORM

(i) / COOPHAVET
23, Rue du Prieuré
Saint Herblon
44150 Ancenis
France
(ii) / Merial
4 Chemin du Calquet
31000 Toulouse
France
Batch release site
COOPHAVET
23, Rue du Prieuré
Saint Herblon
44150 Ancenis
France

7. ASSEMBLERS OF DOSAGE FORM

COOPHAVET
23, Rue du Prieuré
Saint Herblon
44150 Ancenis
France
Primary packaging only
Merial
4 Chemin du Calquet
31000 Toulouse
France

8. IMPORTER OF FINAL DOSAGE FORM FROM OUTSIDE EU

Not applicable

9. DISTRIBUTOR

Merial Animal Health Ltd
PO Box 327
Sandringham House
Harlow Business Park
Harlow
Essex
CM19 5TG

10. DATE OF ISSUE OF ORIGINAL MARKETING AUTHORISATION

16 April 2013

11. APPLICATIONS SINCE ISSUE OF NEW AUTHORISATION

/ Application No / Description / Outcome / Date /
1356/13 / Grouped variation to:
- Change the name of the veterinary medicinal product (VMP) intended to be marketed in the United Kingdom from WELLICOX to ALLEVINIX. It is also proposed a linguistic improvement of the approved English SPC: improvement of the English language that have been assessed not to impact the translations in other national languages.
- Add MERIAL site of Toulouse – France as manufacturing site of the bulk solution and primary packaging. / Granted / 17/02/14
26/14 / Variation to change the distributor, from COOPHAVET (23, Rue du Prieuré, Saint Herblon, 44150 Ancenis, France) to Merial Animal Health Ltd (P.O. Box 327, Sandringham House, Harlow Business Park, Harlow, Essex, CM19 5TG). / Granted / 14/04/14
Application No / Description / Outcome / Date
1666/13 / Grouped variation to delete the control of the weights of the 50 ml, 100 ml, and 250 ml glass and polyethylene terephthalate (PET) bottles, to replace the aluminium tearable capsules (diameter 16 and 32) by aluminium flip-off capsules (diameter 20 and 32) as closure system of the primary packaging.
Also the submission of the updated Ph. Eur. Certificate of Suitability of flunixine meglumine from the already approved manufacturer EXCELLA GMBH: R1-CEP 2006-049-Rev 00, and the submission of the Ph. Eur. Certificate of Suitability of flunixin meglumine from the new manufacturer ZHEJIANG HISOAR PHARMACEUTICAL CO., LTD: RD-CEP 2007-108-Rev 01. / Granted / 30/04/14
25/14 / Variation to register mock-ups for the first time. / Granted / 16/06/14
Reference: / 01016/2014 - Variation to implement the changes made in the Summary of Product Characteristics, labelling, and
package leaflet of the reference product FINADYNE.
Prepared by: / Sara Garton
Authorised by:
Date: / November 2014
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