Zactran (gamithromycin) – Conditions or restrictions regarding supply and use - QJ01FA95

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

MERIAL

4, Chemin du Calquet 31000 Toulouse France

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE

Veterinary medicinal product subject to prescription.

C.STATEMENT OF THE MRLs

The active substance in ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:

Pharmaco-logically

Marker

Animal

MRL

Target

Other

Therapeutic

active substance

residue

species

 

tissues

provisions

classification

Gamithromycin

Gamithro-

Bovine

20 μg/kg

Fat

Not for use in

Anti-

 

mycin

 

200 μg/kg

Liver

animals

infectious

 

 

 

100 μg/kg

Kidney

producing

agents /

 

 

 

 

 

milk for

Antibiotics

 

 

 

 

 

human

 

 

 

 

 

 

consumption

 

 

 

Porcine

100 μg/kg

Muscle

NO ENTRY

 

 

 

 

100 μg/kg

Skin and

 

 

 

 

 

 

fat in

 

 

 

 

 

 

natural

 

 

 

 

 

 

proporti

 

 

 

 

 

 

ons

 

 

 

 

 

100 μg/kg

Liver

 

 

 

 

 

300 μg/kg

Kidney

 

 

 

 

Ovine

50 μg/kg

Muscle

Not for use in

 

 

 

 

50 μg/kg

Fat

animals

 

 

 

 

300 μg/kg

Liver

producing

 

 

 

 

200 μg/kg

Kidney

milk for

 

 

 

 

 

 

human

 

 

 

 

 

 

consumption

 

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.

D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Specific pharmacovigilance requirements:

The periodic safety update report (PSUR) cycle should be re-started 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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