Intracameral Solutions - 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 Intracameral solutions and other brands such as; Mydrane® see below, or for further information on sourcing this product or any others, please don't hesitate to contact us.
What is Tropicamide/Phenylephrine/Lignocaine Intracameral injection?
Intracameral Injections are not licensed in Australia.
Intracameral Injections are indicated for use in eye surgery. For the purpose of obtaining mydriasis and intraocular anesthesia during the surgical procedure, one of such injection like Mydrane® contains two mydriatics, Tropicamide and Phenylephrine and local anaesthetic Lignocaine. This type of injection was developed as an alternative to topical dilating eye drops administered prior to cataract surgery.
Mydrane® Solution Product Supply
Mydrane® is available in Europe as a box of 20 sterile 0.6 mL ampoules and 20 sterile filter needles. Mydrane® is the first marketed product for this indication in Europe, offering a ready-to-use standardized solution with regulatory protection as an alternative to the DIY process already used in some countries.
The supply of unlicensed medicine from overseas in Australia, is often supplied under The Special Access Scheme.
Mydrane® Intracameral Solution for Injection is supplied under Special Access Scheme (SAS) B.
The SAS B system requires the prescriber to notify The TGA of the use.
If a prescriber requires many patients to use Mydrane® Intracameral Injection, they should apply for an Authorised Prescriber approval.