Roche Pharmaceuticals in Ireland

Alecensa is an oral medicine, used for the treatment of people with non-small cell lung cancer (NSCLC) whose tumours are identified as anaplastic lymphoma kinase (ALK)-positive.

Alecensa contains the active substance alectinib and it belongs to a group of drugs called small molecule kinase inhibitors.

Alecensa blocks the action of an enzyme called ‘ALK tyrosine kinase’. Abnormal forms of this enzyme help to encourage cancer cell growth.

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Patient Information Leaflet- 

Avastin was the first anti-angiogenic therapy for the treatment of patients with metastatic colorectal, ovarian, breast, renal cell or non-small cell lung cancer.

Avastin is an intravenous anti-angiogenic therapy that contains the active substance bevacizumab. It belongs to a group of medicines called monoclonal antibodies.

A monoclonal antibody is a type of protein designed to attach to a specific target in the body made by the immune system to help defend the body from infection and cancer. These therapies stop the process of developing new blood vessels in cancer tumours (angiogenesis).

Avastin is used for the treatment of advanced stages of breast, colorectal, non-small cell lung, kidney, ovarian and cervical cancers.

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Patient Information Leaflet - 

CellCept is used in the prevention of organ rejection in patients receiving kidney, heart, or liver transplants.

CellCept is an oral immunosuppressant therapy that contains the active agreement mycophenolate mofetil. CellCept works by reducing the activity of the body's immune system.

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Patient Information Leaflet - 
Patient Information Leaflet - 
Patient Information Leaflet - 
Patient Information Leaflet - 

Columvi is used to treat adults with a cancer called “diffuse large B-cell lymphoma” (DLBCL). It is used when the cancer has come back (relapsed), or did not respond to previous treatments, after two or more lines of systemic therapy.

Diffuse large B-cell lymphoma is a cancer of a part of your immune system (the body’s defences). It affects a type of white blood cell called ‘B cells’. In DLBCL, B cells multiply in an uncontrolled manner and build up in your tissues.

The active substance in Columvi, glofitamab, is a bispecific monoclonal antibody, a type of protein that attaches to two specific targets in the body. It attaches to a specific protein on the surface of B cells, including cancerous B cells, and also to another protein on the surface of T cells (another type of white blood cell). This activates T cells and causes them to multiply. This, in turn, results in the destruction of the B cells, including the cancerous cells.

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Patient Information Leaflet -

Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Cotellic contains the active agreement cobimetinib. It belongs to a group of drugs called small molecule kinase inhibitors and the drug belongs to a family of tyrosine kinase inhibitors.  

Cotellic is an oral drug used in combination with another drug vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

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Patient Information Leaflet -

Esbriet is an oral medicine which contains the active substance pirfenidone and it is used for the treatment of Idiopathic Pulmonary Fibrosis in adults.

IPF is a condition in which the tissues in the lungs become swollen and scarred over time, and as a result makes it difficult to breathe deeply. This makes it hard for the lungs to work properly. Esbriet helps to reduce scarring and swelling in the lungs, and helps someone with IPF breathe better. 

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Erivedge is for the treatment of adult patients with advanced based cell carcinoma.

Erivedge is an anticancer medicine that contains the active substance Vismodegib. It belongs to a group of drugs called small molecule kinase inhibitors.

Erivedge is an anti-cancer medicine that works that works by controlling one of the key proteins involved in basal cell carcinoma. This may slow down or stop the growth of the cancer cells, or may kill them. 

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Evrysdi is used to treat spinal muscular atrophy (SMA), a genetic disease.

SMA is caused by a shortage of a protein called survival motor neuron (SMN) protein in the body. Lack of SMN protein can cause you or your child to lose motor neurons, which are nerve cells that control muscles. This leads to muscle weakness and wasting that can affect everyday movements such as head and neck control, sitting, crawling and walking. The muscles used for breathing and swallowing may also become weaker.

Risdiplam, the active substance in Evrsydi, works by helping the body produce more SMN protein. This means fewer motor neurons are lost, which may improve how well muscles work in people with SMA.

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Gazyvaro is for the treatment of patients with Chronic Lymphocytic Leukaemia (CLL), the common form of Leukaemia and Follicular Lymphoma (FL).

Gazyvaro contains the active ingredient obinutuzumab. It belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body made by the immune system to help defend the body from infection and cancer.

Gazyvaro is approved as an intravenous drug in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukaemia. Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma (FL).

Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

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Patient Information Leaflet -

Hemlibra is a medicine used for treating patients of all ages with haemophilia A (congenital factor VIII deficiency):

• who have developed factor VIII inhibitors

• who have not developed factor VIII inhibitors with:

  • severe disease

  • moderate disease with severe bleeding phenotype

Haemophilia A is an inherited condition caused by a lack of factor VIII, an essential substance required for blood to clot and stop any bleeding.

Hemlibra contains the active substance emicizumab. This belongs to a group of medicines called monoclonal antibodies. Monoclonal antibodies are a type of protein that recognise and bind to a target in the body.

The medicine prevents bleeding or reduces bleeding episodes in people with this condition.

Hemlibra restores the function of missing activated factor VIII that is needed for effective blood clotting. Its structure is different from factor VIII, therefore Hemlibra is not affected by factor VIII inhibitors.

Hemlibra is given by injection under the skin (subcutaneously).

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -
Patient Information Leaflet -

Herceptin is for the treatment of HER2 positive breast or gastric cancer.

Herceptin contains the active ingredient trastuzumab and is classed as humanised monoclonal. It belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body made by the immune system to help defend the body from infection and cancer.

Herceptin is an antibody directed against a cell surface protein produced by the human epidermal growth factor receptor 2 (HER2) gene. HER2 protein is overexpressed in about one-third of all breast cancers.

Herceptin (trastuzumab) is used in the treatment of breast cancer with such characteristics. It is also used with combination chemotherapy in HER2-positive metastatic gastric cancer. Herceptin is an intravenous and subcutaneous used to treat early and advanced breast and gastric cancer.

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Patient Information Leaflet -
Patient Information Leaflet -

Kadcyla is the first antibody drug conjugate used for the treatment of patients with HER2 positive early breast cancer who have residual invasive disease after surgery or unresectable locally advanced or metastatic breast cancer.

Kadcyla contains the active substance trastuzumab emtansine, an antibody drug conjugate which is made up of two parts that are linked together:

trastuzumab - a monoclonal antibody that binds selectively to an antigen (a target protein) called human epidermal growth factor receptor 2 (HER2). HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth. When trastuzumab binds to HER2 it can stop the cancer cells growth and cause them to die.

DM1 – an anti-cancer substance that becomes active once Kadcyla enters the cancer cell. Kadcyla is administered as an intravenous (IV) infusion

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Lunsumio is a cancer medicine used to treat adult patients who have a blood cancer called follicular lymphoma (FL).

In FL, a type of white blood cells called ‘B cells’ become cancerous. The abnormal B cells do not work properly and grow too quickly, crowding out the normal B cells in the bone marrow and lymph nodes that help protect you from infection.

Lunsumio is given to patients who have tried at least two previous treatments for FL, when either the cancer has not responded to them, or it has come back again.

The active substance in Lunsumio, mosunetuzumab, is a monoclonal antibody, a type of protein that attaches to specific targets in the body. In this case, mosunetuzumab attaches to a target substance found on B cells, including the cancerous B cells, and another target found on ‘T cells’, a different type of white blood cell. T cells are another part of the body’s defences that can destroy invading cells. By attaching the two cells together like a bridge, Lunsumio encourages the T cells to destroy the cancerous B cells. This helps control the FL and prevent its spread.

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MabThera (rituximab) may be used for the treatment of several different conditions in adults and children:

Non-Hodgkin’s Lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis or microscopic polyangiitis, pemphigus vulgaris.

MabThera contains the active substance “rituximab”. This is a type of protein called a “monoclonal antibody”. It sticks to the surface of a type of white blood cell called “B-Lymphocyte”. When rituximab sticks to the surface of this cell, the cell dies

MabThera is available as an intravenous (IV) and subcutaneous (SC) therapy and they differ in dosage strength.

The SC formulation of MabThera is used only to treat non-Hodgkin’s lymphoma in adults.

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Patient Information Leaflet -
Patient Information Leaflet -

Madopar works on the central nervous system in the treatment of Parkinson’s disease and restless leg syndrome.

Madopar is an oral tablet contains the active ingredients of levodopa and benserazide. It belongs to a group of medicines called antiparkinsonian agents and is used for the treatment of patients with Parkinson’s disease and restless leg syndrome.  

Madopar works on the central nervous system. Parkinson disease inhibits dopamine levels in certain parts of the brain. This can result in slow movements stiff muscles and tremor. In the body levodopa is changed into dopamine. Dopamine is the active medicine that is needed in your brain to help Parkinson’s disease.

The benserazide allows more of the levodopa you take to get into your brain before it is changed into dopamine.

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -
Patient Information Leaflet -

NeoRecormon is used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD) and to treat chemotherapy-related anaemia in cancer patients.

NeoRecormon is a clear, colourless solution for injection under the skin (subcutaneously) or into a vein (intravenously).It contains a hormone called epoetin beta, which stimulates the production of red blood cells.

Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin. NeoRecormon is used to treat patients with symptomatic anaemia associated with chronic kidney disease (CKD) and to treat chemotherapy-related anaemia in cancer patients.

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -

Ocrevus (ocrelizumab) is licensed to treat relapsing forms of Multiple Sclerosis (RMS) and early Primary Progressive Multiple Sclerosis (PPMS) in adults. It is the first and only medicine approved in the European Union to treat PPMS, a debilitating form of MS in which patients can experience rapidly worsening and irreversible disability.

MS affects approximately 700,000 patients in Europe, of which around 96,000 are diagnosed with PPMS.  Most patients with MS have either RMS or PPMS at diagnosis.

Ocrevus (ocrelizumab) belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to certain cells in the human body.

Ocrevus (ocrelizumab) targets a certain type of immune cell (CD20-positive B cells). These B cells are believed to contribute to the damage to nerve cells and the nerve cell insulation (myelin). This nerve cell damage can lead to relapses and disability in patients with MS.

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -

Perjeta is for the treatment of HER2 positive early and metastatic breast cancer. It is a first in class HER2 dimerisation inhibitor designed to work synergistically with Herceptin and chemotherapy.

Perjeta contains the active ingredient Pertuzumab and is classed as humanised monoclonal. It belongs to a group of medicines called monoclonal antibodies. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body made by the immune system to help defend the body from infection and cancer.

Perjeta is designed to prevent the HER2 receptor from pairing with other HER receptors on the surface of cells, a mechanism that is complementary to another drug called Herceptin.

Perjeta is approved in combination with Herceptin for the treatment of patients with previously untreated HER2-positive metastatic breast cancer. 

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -

Phesgo is a cancer medicine that contains two active substances: pertuzumab and trastuzumab. It is used to treat adult patients with “HER2-positive” breast cancer. 

In early breast cancer (EBC) in combination with chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. 

In metastatic breast cancer (MBC) in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

The two active substance of Phesgo, pertuzumab and trastuzumab are ‘monoclonal antibodies’. They are designed to attach to a specific target on cells called “human epidermal growth factor receptor 2” (HER2). Which is found in large amounts on the surface of some cancer cells and stimulates their growth by attaching to HER2 on cancer cells, pertuzumab and trastuzumab slow down their growth, or kill them.

Usually pertuzumab and trastuzumab are given sequentially. Phesgo as a single treatment administers both pertuzumab and trastuzumab simultaneously.

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -

Piasky is a medicine that is used to treat a disease called paroxysmal nocturnal haemoglobinuria (PNH). It is used in adults and children aged 12 years and older who weigh 40 kg or more, including patients with haemolysis (the breakdown of red blood cells) and clinical symptoms indicating high disease activity and patients whose disease is stable after treatment with a C5 inhibitor for at least the past 6 months. 

PNH can cause the immune system to attack the body’s red blood cells, causing haemolysis. Patients with PNH can require regular blood transfusions. 

Piasky contains the active substance crovalimab. It belongs to a class of medicines called ‘monoclonal antibodies’, which are proteins that are designed to attach to a specific target in the body. Piasky is also  called a complement component 5 (C5) inhibitor.  

Crovalimab attaches to the C5 protein, which is a part of the body’s defence system called the ‘complement  system’. By doing so, it blocks activation of C5, which prevents the immune system from attacking and  damaging red blood cells, thereby reducing the breakdown of red blood cells. This helps to reduce the  symptoms of PNH and the number of blood transfusions required.

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -

Polivy is a cancer medicine used to treat adult patients with “diffuse large B-cell lymphoma” that has never been treated before.

Polivy is also used to treat adults with diffuse large B-cell lymphoma whose cancer has returned or has not got better after at least one previous therapy and when you cannot receive a stem cell transplant.

Diffuse large B-cell lymphoma is a cancer that develops from B lymphocytes also called B-cells. These are a type of blood cells.

The active substance in Polivy is made up of a monoclonal antibody linked to MMAE, a substance that can kill cancer cells. The monoclonal antibody part of the medicine attaches to a target on B cells. Once attached to B cells, the medicine releases MMAE into the B cells and kills them.

Polivy is always given in combination with other cancer medicines for “diffuse large B-cell lymphoma” that has never been treated before and is always given in combination if the cancer has come back or has not got better, after at least one previous therapy, and when you cannot receive a stem cell transplant.

This link will take you to the www.medicines.ie which is a non-Roche website.

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Pulmozyme is used in the treatment of people with cystic fibrosis.

Pulmozyme is a nebulizer inhaled medication with active ingredient of dornase alfa. It is a man-made version of a protein found in your body called ‘DNase’.

Pulmozyme is used for people with cystic fibrosis. It helps by breaking down the thick mucus found in lungs. This helps lungs of people with cystic fibrosis to work better. Pulmozyme is breathed in (inhaled) using something called a nebulizer.

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RoActemra Intravenous infusion formulation (IV) and subcutaneous injection formulation (SC) is used to treat moderate-to-severe active Rheumatoid Arthritis in adults. It is also used to treat active systemic juvenile idiopathic arthritis (sJIA) and active juvenile idiopathic polyarthritis (pJIA) in children aged 2 years and over1,2,3.

RoActemra SC is used to treat Giant Cell Arteritis (GCA) in adult patients, an indication for SC formulations only2,3. 

RoActemra IV is also used to:

- Treat adults and children aged 2 years and over with severe or life-threatening cytokine release syndrome (CRS), a side-effect in which can occur in patients treated with chimeric antigen receptor (CAR) T-cell therapies used to treat certain types of cancer1.

- Treat adults with coronavirus disease 2019 (COVID-19), receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation1.

RoActemra (tocilizumab) contains the active substance tocilizumab which is a protein made from specific immune cells that blocks the action of a specific protein cytokine called interleukin-6 (IL-6). IL-6 is believed to play a key role in activating the inflammatory pathway that contributes to the signs and symptoms of RA and other inflammatory autoimmune conditions. RoActemra (tocilizumab) binds to IL-6 receptors, blocking the pro-inflammatory effect of IL-6 cytokines1, 2, 3.

RoActemra (tocilizumab) is available in both subcutaneous (SC) and intravenous (IV) formulations.

This link will take you to the www.medicines.ie which is a non-Roche website.

1. Patient Information Leaflet - .

2. Patient Information Leaflet - 

3. Patient Information Leaflet - 

Rocephin is an antibiotic given to adults and children intravenously (IV) by infusion or by injection (including newborn babies). It contains the active ingredient ceftraxione and works by killing bacteria that cause infections.

It belongs to a group of medicines called cephalosporins. Rocephin is administered by injection into a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.

It can be given: to treat specific sexually transmitted infections (gonorrhoea and syphilis), to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection, to treat infections of the chest in adults with chronic bronchitis and to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age.

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Patient Information Leaflet -
Patient Information Leaflet -

Rozlytrek is a medicine, used for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options. Rozlytrek is also, used for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitor.

Rozlytrek contains the active substance entrectinib and is a targeted therapy called a kinase inhibitor. It works by blocking the action of abnormal enzymes caused by a change in the NTRK or ROS1 genes that make them. The faulty enzymes encourage the cancer cells to grow.

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -

Tamiflu is used for the prevention and treatment of influenza.

Tamiflu contains the active ingredient oseltamivir, it is an oral anti-viral agent which belongs to a group of medicines named neuraminidase inhibitors.

Tamiflu binds to the neuraminidase on the surface of the virus particles and hence inhibits the new viral particles' chemical ability to escape from the infected cell. The influenza virus is thereby restricted to a smaller number of cells and the body's immune system has a better chance of killing the virus.

Tamiflu helps to ease or prevent the symptoms of the flu virus infection.

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -
Patient Information Leaflet -
Patient Information Leaflet - 
Patient Information Leaflet - 

Tecentriq is used to treat certain types of cancers that affect the lungs called non-small cell lung cancer (NSCLC) and extensive stage small cell lung cancer (ES-SCLC). It is also used to treat a cancer that affects the bladder and the urinary system, called urothelial carcinoma (UC), along with specific type of breast cancer called triple negative breast cancer (TNBC) and hepatocellular carcinoma (HCC), which is a type cancer that affects the liver.

Tecentriq is a monoclonal antibody that contains active substance atezolizumab. A monoclonal antibody is a type of protein designed to recognise and attach to a specific target in the body. It is a type of medication called immunotherapy.

Tecentriq works by attaching to a specific protein in your body called programmed death-ligand 1 (PD-L1). This protein suppresses the body's immune (defence) system, thereby protecting cancer cells from being attacked by the immune cells. By attaching to the protein, Tecentriq helps your immune system to fight your cancer.

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Patient Information Leaflet -

Vabysmo is a medicine for the treatment of neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DME), and visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).

These disorders affect the macula, the central part of the retina (the light-sensitive layer at the back of the eye) that is responsible for fine, central vision. nAMD is caused by the growth of abnormal blood vessels which leak blood and fluid into the macula, and DME is caused by leaky blood vessels that cause swelling of the macula. Central RVO is the blockage of the main blood vessel (vein) that transports blood away from the retina, and branch RVO is the blockage of one of the smaller branches of the main blood vein. Due to the increased pressure within these blood vessels, there is leakage of fluid into the retina, causing swelling of the macula (macular edema).

Vabysmo contains the active substance faricimab, which is belongs to a group of medicines called antineovascularisation agents.

Vabysmo specifically recognises and blocks the activity of proteins known as angiopoietin-2 and vascular endothelial growth factor A. When these proteins are present at higher levels than normal, they can cause growth of abnormal blood vessels and/or damage to normal vessels, with leakage into the macula, causing swelling or damage that can negatively affect a person’s vision. By attaching to these proteins, Vabysmo can block their actions and prevent abnormal vessel growth, leakage and swelling. Vabysmo may improve the disease and/or slow down worsening of the disease and thereby maintain, or even improve, your vision.

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Patient Information Leaflet -
Patient Information Leaflet - 

Zelboraf is for the treatment of patients with metastatic melanoma with BRAF V600 mutation.

Zelboraf is an anticancer medicine that contains the active substance vemurafenib. It belongs to a group of drugs called small molecule kinase inhibitors.

It is used to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It can only be used in patients whose cancer has a change (mutation) in the “BRAF” gene - BRAF V600 mutations. This change may have led to the development of melanoma. Zelboraf targets proteins made from this modified gene and slows down or stops the development of the cancer.

This link will take you to the www.medicines.ie which is a non-Roche website.

Patient Information Leaflet -