Acticam

Withdrawn

This medicine's authorisation has been withdrawn

meloxicam

Overview

The marketing authorisation for Acticam has been withdrawn at the request of the marketing-authorisation holder.

What is Acticam?

Acticam contains meloxicam which belongs to a class of medicines having anti-inflammatory action. Acticam is presented as an oral suspension 1.5 mg/ml for dogs (to be given mixed with food) and a solution for injection 5mg/ml.

Acticam is a ‘generic’: this means that Acticam is similar to a ‘reference veterinary medicine’ already authorised in the European Union (EU) (Metacam 1.5 mg/ml oral suspension). Studies have been carried out to prove that Acticam is ‘bioequivalent’ to the reference veterinary medicine: this means that Acticam is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.

What is Acticam used for?

Dogs: Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders and reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery.

Cats: Reduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.

How does Acticam work?

Acticam contains meloxicam, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Meloxicam acts by inhibition of prostaglandin synthesis. As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.

How has Acticam been studied?

Acticam has been investigated in comparison with Metacam which is already authorised in the EU. A study looked at how Acticam was absorbed and its effects in the body, in comparison with Metacam oral suspension 1.5 mg/ml.

What benefit has Acticam shown during the studies?

Acticam is efficacious in alleviating the inflammation and pain in both acute and chronic musculoskeletal disorders and reducing the postoperative pain following orthopaedic and soft-tissue surgery in dogs and in reducing the postoperative pain after ovariohysterectomy and minor soft-tissue surgery in cats.

What is the risk associated with Acticam?

Occasional side effects of Acticam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality). These side effects occur usually within the first week of treatment and are generally temporary. They disappear once treatment has stopped. In very rare cases, they may be serious or fatal.

Acticam should not be administered to pregnant or lactating animals as the safety of the product has not been established in these cases. Acticam should also not be used in animals suffering from gastrointestinal or haemorrhagic disorders and impaired renal or hepatic function, animals with known hypersensitivity to NSAIDs, and animals less than six weeks of age or in cats of less than 2 kg.

An oral follow-up therapy using meloxicam or other NSAIDs should not be used in cats, as no safe dosage for repeated oral administration has been established.

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

People with known hypersensitivity (allergic) to meloxicam should avoid contact with the product.

Accidental self-injection may give rise to pain.

If the product is swallowed by a person, the advice of a doctor should be sought immediately.

In case of accidental self-injection, medical advice should be sought immediately showing the package leaflet or the label to the physician.

Why has Acticam been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with EU requirements, Acticam has been shown to be bioequivalent to Metacam 1.5 mg/ml oral suspension. The CVMP concluded that the benefits of Acticam exceed the risks for the alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders, reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery in dogs and reduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery in cats and recommended that Acticam be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion of this EPAR.

Other information about Acticam:

The European Commission granted a marketing authorisation, valid throughout the EU for Acticam on 9 December 2008. Information on the prescription status of this product may be found on the label / outer package.

Acticam : EPAR - Summary for the public

Product information

Acticam : EPAR - Product information

Acticam : EPAR - All authorised presentations

Product details

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

Therapeutic indication

Oral suspension:

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.

Solution for injection:

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.

Reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery.

Cats:

Reduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.

Authorisation details

• EMA product number:
  EMEA/V/C/000138
• 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:
  Ecuphar

  Legeweg 157-I; B-8020 Oostkamp; Belgium

• Opinion adopted:
  15/10/2008
• Marketing authorisation issued:
  09/12/2008
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

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

Acticam : EPAR - Scientific conclusion - Article-45 referral

Adopted

Initial marketing authorisation documents

Acticam : EPAR - Scientific discussion

Adopted

Acticam : EPAR - Procedural steps taken before authorisation

CVMP summary of opinion for Acticam

Adopted Reference Number: EMEA/CVMP/512781/2008