At Roche Pharmaceuticals, we focus on finding new medicines that help patients live longer, better lives and evolve the practice of medicine.

This page lists Roche Australia’s pharmaceutical medicines. Use the search function to search by active ingredient, brand name or disease area, to find the Product Information (PI) and Consumer Medicine Information (CMI) for each product.

Actemra® (tocilizumab)

Statement for Actemra Supply Constraints

Roche is currently experiencing shortages of multiple presentations of ACTEMRA® (tocilizumab) in Australia due to an increase in global and local demand in response to the COVID-19 pandemic.  Roche will not be able to resume normal levels of supply of either ACTEMRA® intravenous (IV) or subcutaneous (SC) formulations until January 2022.

Roche would like to provide the following update on the availability of ACTEMRA® in Australia and its impact on patients:

ACTEMRA® IV formulations:
Based on modelling from the Medicines Availability Working Group (MAWG), the Australian Rheumatology Association (ARA) and Therapeutic Goods Administration (TGA) have advised clinicians that the use of ACTEMRA® IV in Australia needs to be significantly reduced in order to preserve remaining stock and to ensure that patients who have no alternatives can be treated.  Please refer to the TGA website for the joint statement on patient management and supply allocations of ACTEMRA® IV, including information on priority indications as determined by the ARA and TGA.

In addition, Roche is collaborating with the TGA, MAWG, ARA, Medicines Australia and wholesalers to allocate agreed amounts of the available supply of ACTEMRA® IV to customers.  Effective immediately, all supply of ACTEMRA® will only be via wholesalers.  Roche will not supply ACTEMRA® IV directly to any hospitals or pharmacies.

ACTEMRA® Subcutaneous formulations:
There is limited stock of ACTEMRA® pre-filled syringes (PFS) and ACTEMRA® pre-filled pens (ACTPen).  Please refer to the TGA website for detailed status of each formulation.  Roche has also put its ACTEMRA® sampling program on hold.

Due to the limited availability of ACTEMRA® SC formulations, Roche does not recommend switching patients from IV to SC during this period of shortage.  A joint statement has been developed by the TGA, the ARA and Arthritis Australia, providing guidance for prescribers to manage patients on ACTEMRA® during this period of constrained supply.  Please refer to the TGA website for this information.

The TGA has issued a Serious Scarcity Substitution Instrument (SSSI) to assist with timely access to ACTEMRA® SC formulations for patients effective until 31 December 2021.  This SSSI declares ACTEMRA® PFS and ACTPen as scarce and substitutable medicines, making the medicines effectively interchangeable at the pharmacy level.  Please refer to the TGA website for details.

Further information:
The global supply situation for ACTEMRA® is constantly evolving.  In order to address this, Roche is using its best endevours to increase manufacturing capacity and supply by leveraging its global networks and collaborating with external partners to cover the ACTEMRA® demand globally for patients currently on therapy.

Roche continues to work closely with the TGA and other stakeholders with the goal of minimising the impact on patients in Australia.  We will provide further information as the situation evolves.

Further information can be found on the TGA website.

Actemra® (tocilizumab)

Availability of Actemra® (tocilizumab):

  • Pre-filled syringe for subcutaneous (SC) injection
  • Pre-filled pen for subcutaneous (SC) injection
  • Intravenous (IV) solution for infusion

Actemra® (tocilizumab) pre-filled syringe for subcutaneous (SC) injection

Patients
Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Actemra® (tocilizumab) pre-filled pen for subcutaneous (SC) injection

Patients
Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Actemra® (tocilizumab) intravenous (IV) solution for infusion

Patients
Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Alecensa® (alectinib)

Alecensa® (alectinib)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Avastin® (bevacizumab)

Avastin® (bevacizumab)

Patients

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Healthcare Professionals
Product Information (PI)

CellCept® (mycophenolate mofetil)

CellCept® (mycophenolate mofetil)

Patients

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Healthcare Professionals
Product Information (PI)

Cotellic® (cobimetinib)

Cotellic® (cobimetinib)

Patients

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Healthcare Professionals
Product Information (PI)

Enspryng® (satralizumab)

Enspryng® (satralizumab)

Patients

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Healthcare Professionals
Product Information (PI)

Erivedge® (vismodegib)

Erivedge® (vismodegib)

Patients

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Healthcare Professionals
Product Information (PI)

Esbriet® (pirfenidone)

Esbriet® (pirfenidone)

Availability of Esbriet® (pirfenidone):

  • Tablets
  • Capsules

Esbriet® (pirfenidone) tablets

Patients
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Healthcare Professionals
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Esbriet® (pirfenidone) capsules

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Product Information (PI)

Evrysdi® (risdiplam)

Evrysdi® (risdiplam)

Patients

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Product Information (PI)

Fuzeon® (enfuvirtide)

Fuzeon® (enfuvirtide)

Patients

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Healthcare Professionals
Product Information (PI)

Gazyva® (obinutuzumab)

Gazyva® (obinutuzumab)

Patients

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Healthcare Professionals
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Hemlibra® (emicizumab)

Hemlibra® (emicizumab)

Patients
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Healthcare Professionals
Product Information (PI)

Herceptin® (trastuzumab) powder for IV infusion

Herceptin® (trastuzumab) powder for IV infusion

Patients

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Healthcare Professionals
Product Information (PI)

Herceptin® SC (trastuzumab) solution for SC injection

Herceptin® SC (trastuzumab) solution for SC injection

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Invirase® (saquinavir)

Invirase® (saquinavir)

Patients

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Healthcare Professionals

Product Information (PI)

Kadcyla® (trastuzumab emtansine)

Kadcyla® (trastuzumab emtansine)

Patients

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Healthcare Professionals
Product Information (PI)

MabThera® (rituximab) solution for IV infusion

MabThera® (rituximab) solution for IV infusion

Patients

NHL/CLL Consumer Medicine Information (CMI)

RA/GPA/MPA Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

MabThera® SC (rituximab) solution for SC injection

MabThera® SC (rituximab) solution for SC injection

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Madopar® (levodopa and benserazide)

Madopar® (levodopa and benserazide)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Mircera® (methoxy polyethylene glycolepoetin beta)

Mircera® (methoxy polyethylene glycolepoetin beta)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals 
Product Information (PI)

NeoRecormon® (epoetin beta)

NeoRecormon® (epoetin beta)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Ocrevus® (ocrelizumab)

Ocrevus® (ocrelizumab)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Pegasys® (peginterferon alfa-2a)

Pegasys® (peginterferon alfa-2a)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Perjeta® (pertuzumab)

Perjeta® (pertuzumab)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Polivy® (polatuzumab vedotin)

Polivy® (polatuzumab vedotin)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Pulmozyme® (dornase alfa)

Pulmozyme® (dornase alfa)

Patients

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Healthcare Professionals
Product Information (PI)

Rivotril® (clonazepam)

Rivotril® (clonazepam)

In August 2021, Roche transferred the sponsorship and management of supply, customer support, medical information, regulatory services, sales and marketing of Rivotril (clonazepam) to Pharmaco Australia Ltd within Australia. The current Consumer Medicine Information (CMI) and Product Information (PI) for Valium are available from the Therapeutic Goods Administration (TGA) website at: https://www.ebs.tga.gov.au/

Roaccutane® (isotretinoin)

Roaccutane® (isotretinoin)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Rocaltrol® (calcitriol)

Rocaltrol® (calcitriol)

Please be advised that Roche has transitioned responsibility of Rocaltrol to Atnahs. Please contact Atnahs for the current Product Information (PI) and Consumer Medicine Information (CMI).

Ronapreve® (casirivimab and imdevimab)

Ronapreve® (casirivimab and imdevimab)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Rozlytrek® (entrectinib)

Rozlytrek® (entrectinib)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals 
Product Information (PI)

Tamiflu® (oseltamivir) capsules

Tamiflu® (oseltamivir) capsules

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Tamiflu® (oseltamivir) suspension

Tamiflu® (oseltamivir) suspension availability - 26 June 2019

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Tarceva® (erlotinib)

Tarceva® (erlotinib)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Tecentriq® (atezolizumab)

Tecentriq® (atezolizumab)

Roche update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer - IMpassion131 results.

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Valcyte® (valganciclovir) powder for oral solution

Valcyte® (valganciclovir) powder for oral solution

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Valcyte® (valganciclovir) tablets

Valcyte® (valganciclovir) tablets

Patients
Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Valium® (diazepam)

Valium® (diazepam)

In August 2021, Roche transferred the sponsorship and management of supply, customer support, medical information, regulatory services, sales and marketing of Valium (diazepam) to Atnahs Pharma Australia Pty Ltd within Australia. The current Consumer Medicine Information (CMI) and Product Information (PI) for Valium are available from the Therapeutic Goods Administration (TGA) website at: https://www.ebs.tga.gov.au/

Xofluza® (Baloxavir marboxil)

Xofluza® (baloxavir marboxil)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)

Zelboraf® (vemurafenib)

Zelboraf® (vemurafenib)

Patients

Consumer Medicine Information (CMI)

Healthcare Professionals
Product Information (PI)