Acticam

meloxicam

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This is a summary of the European public assessment report (EPAR). 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 recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

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.

Name Language First published Last updated
Acticam : EPAR - Summary for the public BG = bălgarski 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public ES = español 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public CS = čeština 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public DA = dansk 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public DE = Deutsch 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public ET = eesti keel 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public EL = elliniká 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public EN = English 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public FR = français 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public IT = italiano 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public LV = latviešu valoda 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public LT = lietuvių kalba 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public HU = magyar 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public MT = Malti 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public NL = Nederlands 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public PL = polski 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public PT = português 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public RO = română 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public SK = slovenčina 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public SL = slovenščina 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public FI = suomi 2009-01-05 2012-02-03
Acticam : EPAR - Summary for the public SV = svenska 2009-01-05 2012-02-03

This EPAR was last updated on 12/12/2013 .

Authorisation details

Product details

Product details for Acticam
NameActicam
Agency product numberEMEA/V/C/000138
Active substance

meloxicam

International non-proprietary name (INN) or common name

meloxicam

Species DogsCats
Anatomical therapeutic chemical veterinary (ATCvet) codeQM01AC06
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Acticam
Marketing-authorisation holder

Ecuphar

Revision6
Date of issue of marketing authorisation valid throughout the European Union09/12/2008

Contact address:

Ecuphar
Legeweg 157-I
B-8020 Oostkamp
Belgium

Product information

Product information

09/12/2013  Acticam -EMEA/V/C/000138 -R/0013

Name Language First published Last updated
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Product information SV = svenska 2009-11-18 2013-12-12

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02
Acticam : EPAR - All authorised presentations SV = svenska 2009-01-05 2011-05-02

Pharmacotherapeutic group

Anti-inflammatory and antirheumatic products

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Acticam : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-11-18 2013-12-12
Acticam : EPAR - Scientific conclusion - Article-45 referral SV = svenska 2011-05-02  

Initial marketing-authorisation documents

Name Language First published Last updated
Acticam : EPAR - Procedural steps taken before authorisation SV = svenska 2009-01-05  
Acticam : EPAR - Scientific discussion SV = svenska 2009-01-05  
CVMP summary of opinion for Acticam SV = svenska 2008-10-17  

Authorised

This medicine is approved for use in the European Union

News

More information on Acticam

The marketing authorisation for Acticam oral suspension for dogs is currently suspended. See: