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Dexamethasone Eye Drops - TGA Unlicensed Products

 

HL Pharma has exclusive distribution rights for numerous products and also specialises in sourcing and supply of products that are unlicensed in Australia.

These products may not have TGA registration or maybe an Australian product with supply issues. They are usually supplied under The Special Access Scheme (SAS) or Authorised Prescriber Scheme (APS). Other pathways to supply include Clinical Trial Supply.

For more product information on Dexamethasone Eye Drops or brands such as Dexafree® see below or for further information on sourcing this product or any others, please don't hesitate to contact us.

 

 

Dexamethasone Eye Drops

What is Dexamethasone Preservative Free Eye Drops 1mg/ml used for?

There are no TGA licensed Dexamethasone preservative-free eye drops available in Australia.

Dexamethasone is used under the Special Access Scheme (SAS) for the treatment of inflammatory conditions of the eye.

Many studies have reported different symptoms between preserved and non-preserved eye drops. In one study on 9658 patients, 42% of the patients felt a sensation of a foreign body on the instillation of preserved eye drops, making preservative-free drops a better option for most patients. 

Preservative Eye Drop Study 

 

Supply and Licensing of Dexamethasone Eye Drops

Dexamethasone Preservative-free eye drops, including other brands such as Dexafree® are licensed in a number of countries including The United Kingdom and various countries throughout Europe.

The requirement for preservative-free eye drops is becoming imperative.

The supply of unlicensed medicine from overseas in Australia is available under The Special Access Scheme.

Dexamethasone preservative Free eye drops 1mg/ml, including brands such as Dexafree®, is often supplied under Special Access Scheme (SAS) C for treatment of eye inflammatory conditions which are non-infected and steroid-responsive - for patients sensitive to the preservative-containing formulation.

The SAS C system just requires the prescriber to notify The TGA of the use.

TGA Special Access Scheme

If a prescriber requires many patients to use Dexamethasone preservative-free 1mg/ml or other brands such as Dexafree®, they can apply for an Authorised Prescriber approval. 

HL Pharma is a specialist supplier of medicines from overseas. Please contact us for assistance or further information.