August 2018

Important New Products

• Dolutegravir (sodium)/rilpivirine (hydrochloride) (Juluca) contains two human ...(more)
• Follitropin delta (rhu) (Rekovelle) is a recombinant human follicle stimulating hormone ...(more)
• Glecaprevir/pibrentasvir (Maviret) contains two pangenotypic direct acting antivirals, ...(more)
• Haemophilus type b tetanus protein conjugate vaccine (Act-HIB) contains the capsular ...(more)
• Insulin degludec/insulin aspart (rys) (Ryzodeg 70/30) is a soluble insulin analogue product ...(more)

New Indications

• Denosumab (rch) (Prolia) is now indicated to increase bone mass in women and men at ...(more)
• Ixekizumab (rch) (Taltz) is now indicated for the treatment of active psoriatic arthritis in ...(more)
• Nepafenac (Ilevro) is now indicated for the reduction in risk of postoperative macular oedema ...(more)
• Pembrolizumab (Keytruda) in combination with pemetrexed and platinum chemotherapy is now ...(more)
• Trametinib (Mekinist) in combination with dabrafenib is now indicated for the adjuvant ...(more)

New Contraindications

• Clarithromycin (Klacid) is now contraindicated with concurrent administration of domperidone.
• Diclofenac sodium (Voltaren) and diclofenac potassium (Voltaren Rapid) are now ...(more)
• Eicosapentaenoic acid (EPA) ethyl ester/docosahexaenoic acid (DHA) ethyl ester ...(more)
• Eliglustat (Cerdelga) is now contraindicated in the following: CYP2D6 intermediate ...(more)

Active Ingredient Naming Changes

In this release, MIMS Australia will be including the following INNs (International Non-proprietary Names) as well as Australian Approved Names (AANs) as part of our push to support the Therapeutic Goods Administration (TGA) active ingredient name changes project.  

MIMS will begin referring to these ingredients by their new names, however, users may continue to search by the old AANs if preferred. ...(more)

Biosimilar Awareness Initiative

The Biosimilar Awareness Initiative by the Department of Health is intended to support awareness of, and confidence in, the use of biosimilar medicines for healthcare professionals and consumers.
 
Information about the Initiative can be found on the Department of Health website: http://www.health.gov.au/internet/main/publishing.nsf/Content/biosimilar-awareness-initiative