Diurizone 50ml

PRODUCT SUMMARY
PUBLIC ASSESSMENT REPORT
The public assessment report reflects the scientific conclusion reached by the HPRA at the end of the evaluation process and provides a summary of the grounds for approval of the marketing authorisation for the specific veterinary medicinal product. It is made available by the HPRA for information to the public, after the deletion of commercially confidential information. The legal basis for its creation and availability is contained in Article 25.4 of EC Directive 2001/82/EC as amended by Directive 2004/28/EC for veterinary medicinal products. It is a concise document which highlights the main parts of the documentation submitted by the applicant and the scientific evaluation carried out by HPRA leading to the approval of the product for marketing in Ireland.
The Summary of Product Characteristics (SPC) for this product is available on the HPRA website.

I SCIENTIFIC OVERVIEW
The initial application for the product was assessed before there was a requirement to have a public assessment report, therefore no details in this section are available. Please refer to Section VI for significant post-approval changes which are important for the quality, safety and efficacy of the product.

II QUALITY ASPECTS
See section I.

III SAFETY AND RESIDUES ASSESSMENT (PHARMACO-TOXICOLOGICAL) See section I.
Name, strength and pharmaceutical form : Diurizone Injectable
Active substance(s):  Hydrochlorothiazide, Dexamethasone
Marketing Authorisation in Ireland:  Vetoquinol Ireland Limited First Floor, Segrave House 19/20 Earlsfort Terrace Dublin 2

Target species Cattle, Horses declared as not being intended for slaughter for human consumption.

Indication for use Cattle:
- Congestion and oedema of the udder
- Persistent oedema during lactation
- Pulmonary congestion and oedema
- Oedema of surgical wounds
- Oedema of allergic conditions

Horses:
- Generalised congestion and oedema
- Oedema of sheath
- Anasarca
- Oedema in allergic conditions
ATCvet code QC03AX01

IV CLINICAL ASSESSMENT (EFFICACY)
See section I.

V OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT
On the basis of the original data submitted, the HPRA considered that the product demonstrated adequate evidence of efficacy for the approved indications as well as a satisfactory benefit/risk profile and therefore granted a marketing authorisation.

VI POST-AUTHORISATION ASSESSMENTS
The SPC and package leaflet may be updated to include new information on the quality, safety and efficacy of the veterinary medicinal product. The current SPC is available on the HPRA website. 
This section contains information on significant changes which have been made after the original procedure which are important for the quality, safety or efficacy of the product.
Quality Changes
Summary of change :Change in the name and/or address of the marketing authorisation holder (CRN 7021600)
Approval date : August 2015

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