Draxxin (tulathromycin) – Conditions or restrictions regarding supply and use - QJ01FA94

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Draxxin 100 mg/ml: FAREVA AMBOISE Zone Industrielle,

29 route des Industries

37530 Pocé-sur-Cisse FRANCE

or

Zoetis Manufacturing & Research Spain, S.L.

Ctra. de Camprodon, s/n

Finca La Riba

Vall de Bianya 17813 (Gerona)

SPAIN

Draxxin 25 mg/ml: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription.

C.STATEMENT OF THE MRLs

The active substance in Draxxin is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:

Pharmaco-

Marker residue

Animal

MRLs

Target

Other

Therapeutic

logically active

 

species

 

tissues

provisions

classification

substance

 

 

 

 

 

 

Tulathromycin

(2R, 3S, 4R,

Ovine,

450 µg/kg

Muscle

Not for use

Anti-

 

5R, 8R, 10R,

caprine

250 µg/kg

Fat

in animals

infectious

 

11R, 12S, 13S,

 

5400 µg/kg

Liver

from which

agents/

 

14R)-2-ethyl-

 

1800 µg/kg

Kidney

milk is

Antibiotics’

 

3,4,10,13-

 

 

 

produced for

 

 

tetrahydroxy-

Bovine

300 µg/kg

Muscle

human

 

 

3,5,8,10,12,14-

 

200 µg/kg

Fat

consumption.

 

 

hexamethyl-

 

4500 µg/kg

Liver

 

 

 

11-[[3,4,6-

 

3000 µg/kg

Kidney

 

 

 

trideoxy-3-

 

 

 

 

 

 

(dimethylamin

 

 

 

 

 

 

Porcine

800 µg/kg

Muscle

 

 

 

o)-ß-D-

 

300 µg/kg

Skin and

 

 

 

xylohexopyra-

 

 

fat in

 

 

 

nosyl]oxy]-1-

 

 

natural

 

 

 

oxa-6-

 

 

proportions

 

 

 

azacyclopent-

 

4 000 µg/kg

Liver

 

 

 

de-can-15-one

 

8 000 µg/kg

Kidney

 

 

 

expressed as

 

 

 

 

 

 

tulathromycin

 

 

 

 

 

 

equivalents

 

 

 

 

 

The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.

D.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Specific pharmacovigilance requirements:

The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.

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