Emdocam (meloxicam) - QM01AC06
Updated on site: 09-Feb-2018
- What is Emdocam?
- How does Emdocam work?
- How has Emdocam been studied?
- What benefit has Emdocam shown during the studies?
- What is the risk associated with Emdocam?
- What are the precautions for the person who gives the medicine or comes into contact with the animal?
- What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
- What is the time to allow before milk can be taken from the animal for human consumption?
- Why has Emdocam been approved?
This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendation for authorisation and the conditions of use.
This document cannot replace a
What is Emdocam?
Emdocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam. It is available as a clear yellow solution for injection (20 mg/ml).
Emdocam is a ‘generic’ medicine which means that Emdocam is similar to a ‘reference veterinary medicine’ already authorised in the EU (Metacam). Emdocam is ‘bioequivalent’ to the reference medicine which means that it is equivalent to Metacam in the way it is absorbed and used by the body.
What is Emdocam used for?
Emdocam is used in horses to relieve colic (abdominal pain) and the inflammation and pain in
In cattle it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder). It can be used with oral
It is used in pigs to reduce the symptoms of lameness and inflammation in
farrowing (giving birth) such as puerperal septicaemia and toxaemia
How does Emdocam work?
Emdocam contains meloxicam, which belongs to a class of medicines called
How has Emdocam been studied?
No studies in cattle, pigs and horses were required as Emdocam is given by injection and has a similar composition as the reference medicine, Metacam.
- Halagon - Emdoka BVBA
Prescription drugs listed. Manufacturer: "Emdoka bvba"
What benefit has Emdocam shown during the studies?
Emdocam was considered to be bioequivalent with the reference medicine. Consequently, Emdocam’s benefit is taken as being the same as that of the reference medicine.
What is the risk associated with Emdocam?
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
In horses, a transient swelling at the injection site can occur but resolves without intervention. In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Emdocam.
In case of accidental
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
The withdrawal period is 15 days for cattle and five days for pigs and horses.
What is the time to allow before milk can be taken from the animal for human consumption?
Milk can be taken five days after administration in cattle. The medicine should not be used in horses producing milk for human consumption.
Why has Emdocam been approved?
The CVMP considered that, in accordance with European Union requirements, Emdocam is bioequivalent to Metacam. Therefore the CVMP’s view was that, as for Metacam, Emdocam’s benefits
are greater than its risks when used for the approved indications. The Committee recommended that Emdocam be given a marketing authorisation. The
Other information about Emdocam:
The European Commission granted a marketing authorisation valid throughout the European Union, for Emdocam to Emdoka bvba on 18 August 2011. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated on 18 August 2011.