Melosus

Authorised

This medicine is authorised for use in the European Union

meloxicam

Overview

Melosus is an anti-inflammatory medicine used in dogs, cats and guinea pigs.

Dogs

In dogs, Melosus is used to lessen inflammation and pain in musculo-skeletal disorders.

Cats

In cats, Melosus is used to reduce pain and inflammation after orthopaedic and minor soft tissue surgery. Moreover, it is used to lessen pain and inflammation in chronic musculo-skeletal disorders.

Guinea pigs

In guinea pigs Melosus is used to reduce pain after soft tissue surgery such as castration.

Melosus contains the active substance meloxicam and is a ‘generic medicine’. This means that Melosus contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Metacam.

How is Melosus used?

Melosus is available as an oral (taken by mouth) suspension as 0.5 mg/ml for use in cats and guinea pigs and 1.5 mg/ml for use in dogs. The dose depends on the animal, the bodyweight and condition and is given mixed with food or directly into the mouth for dogs and cats and directly into the mouth for guinea pigs.

Melosus can only be obtained with a prescription. For further information about using Melosus, see the package leaflet or contact your veterinarian or pharmacist.

How does Melosus work?

Melosus contains meloxicam, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins. As prostaglandins trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of inflammation.

How has Melosus been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Metacam, and do not need to be repeated for Melosus.

As for every medicine, the company provided studies on the quality of Melosus. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the benefits and risks of Melosus?

Because Melosus is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Safety information has been included in the summary of product characteristics and the package leaflet for Melosus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. The precautions are the same as for the reference medicine since Melosus is a generic medicine.

Why is Melosus authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Melosus has been shown to have comparable quality and to be bioequivalent to Metacam. Therefore, the Agency’s view was that, as for Metacam, the benefit of Melosus outweighs the identified risk and it can be authorised for use in the EU.

Other information about Melosus

Melosus received a marketing authorisation valid throughout the EU on 21 February 2011.

Melosus : EPAR - Medicine overview

AdoptedReference Number: EMA/CVMP/510011/2010

Product information

Melosus : EPAR - Product Information

Latest procedure affecting product information: II/0012

20/01/2021

Melosus : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Melosus
• Active substance:
  meloxicam
• International non-proprietary name (INN) or common name:
  meloxicam
• Species:
  • Dogs
  • Cats
  • Guinea pigs
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QM01AC06

Pharmacotherapeutic group

Musculo-skeletal system

Therapeutic indication

Dogs:

• Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Cats:

• Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
• Alleviation of pain and inflammation in chronic musculo-skeletal disorders in cats.

Guinea pigs:

• Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.

Authorisation details

• EMA product number:
  EMEA/V/C/002001
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  CP-Pharma Handelsgesellschaft mbH

  Ostlandring 13; 31303 Burgdorf; Germany

• Opinion adopted:
  08/12/2010
• Marketing authorisation issued:
  21/02/2011
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Melosus : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Melosus : EPAR - Scientific Discussion

CVMP summary of positive opinion for Melosus

AdoptedReference Number: EMA/CVMP/144729/2010