Loxicom (meloxicam) – Conditions or restrictions regarding supply and use - QM01AC06

Updated on site: 21-Sep-2017

Medication name: Loxicom
ATC: QM01AC06
Substance: meloxicam
Manufacturer: Norbrook Laboratories Limited

Loxicom 0.5 mg/ml oral suspension for dogs

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Norbrook Laboratories Limited

105 Armagh Road

Newry

Co. Down, BT35 6PU

United Kingdom

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

To be supplied only on veterinary prescription.

C.STATEMENT OF MRLs

Not applicable.

Loxicom 1.5 mg/ml oral suspension for dogs

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Norbrook Laboratories Limited

105 Armagh Road

Newry

Co. Down, BT35 6PU

United Kingdom

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

Veterinary medicinal product subject to prescription

C. STATEMENT OF MRLs

Not applicable.

Loxicom 5 mg/ml solution for injection for dogs and cats

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Norbrook Laboratories Limited

105 Armagh Road

Newry

Co. Down, BT35 6PU

United Kingdom

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

Veterinary medicinal product subject to prescription

C. STATEMENT OF MRLs

Not applicable.

Loxicom 0.5 mg/ml oral suspension for cats

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Norbrook Laboratories Limited

105 Armagh Road

Newry

Co. Down, BT35 6PU

United Kingdom

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

Veterinary medicinal product subject to prescription

C. STATEMENT OF MRLs

Not applicable.

Loxicom 20 mg/ml solution for injection for cattle, pigs and horses.

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Norbrook Laboratories Limited

105 Armagh Road

Newry

Co. Down, BT35 6PU

United Kingdom

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

Veterinary medicinal product subject to prescription

C. STATEMENT OF MRLs

The active substance in Loxicom 20 mg/ml solution for injection for cattle, pigs and horses is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:

Pharmacologically

Marker

Animal

MRL

Target

Other

Therapeutic

active substance

residue

species

 

tissues

provisions

classification

Meloxicam

Meloxicam

Bovine,

20 µg/kg

Muscle

NO

Anti-

 

 

caprine,

65 µg/kg

Liver

ENTRY

inflammatory

 

 

porcine,

65 µg/kg

Kidney

 

agents/

 

 

rabbit,

 

 

 

Nonsteroidal

 

 

Equidae

 

 

 

anti-

 

 

Bovine,

15 µg/kg

Milk

 

inflammatory

 

 

caprine

 

 

 

agents

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

Loxicom 1 mg chewable tablets for dogs

Loxicom 2.5 mg chewable tablets for dogs

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Norbrook Laboratories Limited

105 Armagh Road

Newry

Co. Down, BT35 6PU

United Kingdom

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE

Veterinary medicinal product subject to prescription

C. STATEMENT OF MRLs

Not applicable.

Loxicom 50 mg/g oral paste for horses

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Norbrook Laboratories Limited

105 Armagh Road

Newry

Co. Down, BT35 6PU

United Kingdom

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Veterinary medicinal product subject to prescription

C.STATEMENT OF THE MRLs

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

Pharmacologically

Marker

Animal

MRLs

Target

Other

Therapeutic

active substance(s)

residue

species

 

tissues

provisions

classification

 

 

 

 

 

 

 

Meloxicam

Meloxicam

Bovine,

20 μg/kg

Muscle

No entry

Anti-

 

 

caprine,

65 μg/kg

Liver

 

inflammatory

 

 

porcine,

65 μg/kg

Kidney

 

agents/Non-

 

 

rabbit,

 

 

 

steroidal anti-

 

 

Equidae

 

 

 

inflammatory

 

 

 

 

 

 

agents

 

 

 

 

 

 

 

 

 

Bovine,

15 μg/kg

Milk

 

 

 

 

caprine

 

 

 

 

 

 

 

 

 

 

 

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

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