Thirty-two medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines.
Roche is also dedicated to making a sustainable contribution to society. We have been recognised as a Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry for twelve years in a row by the Dow Jones Sustainability Indices (DJSI).
We are a force of close to 98,000 people working together across 100 countries.with almost 90 people working right here in Ireland. Our Irish office is located in Dublin and Roche team members here work in access, business strategy, commercial, finance and business operations, healthcare innovation, licence to operate, medical and people and culture. We are proud to have colleagues join the team from around the world and from varied backgrounds and proud of the work we do together. We are networked and collaborative and united in our focus in making Ireland a better place for patients.
Roche is dedicated to supporting patients and patient groups and has provided grants, sponsorships and donations to Irish groups and organisations dedicated to making a difference in the lives of patients. We are committed to patient groups and have built strong and lasting partnerships with organisations such as the Irish Haemophilia Society, the Irish Lung Fibrosis Association, the Marie Keating Foundation and MS Ireland.
As a global pioneer in pharmaceuticals and diagnostics, we have spent more than €3 million since 2014 supporting Irish clinical trials, as we seek to find new ways to help people live longer, healthier lives. In the last seven years, Roche has brought 13 new molecules across 21 indications medicines to patients in Ireland. We continue to work with Irish health authorities to give Irish patients the best possible access to new and innovative medicines. Roche is also the number one supplier of hospital medicines in Ireland.
Looking to the future and our mission of doing now what patients need next, we are working hard to advance the concept of 'personalised healthcare' – transforming lives by delivering care tailored to each individual – helping to prevent, diagnose and treat illnesses more effectively.
You can keep up to date with Roche's activities and news in Ireland by following
Pharmaceutical Products
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.
Patient Information Leaflet
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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.
Patient Information Leaflet (PIL)
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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.
Patient Information Leaflet (PIL)
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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.
Patient Information Leaflet (PIL)
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Esbriet is an oral medicine approved for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and is available in approximately 40 countries worldwide.
Esbriet is an oral tablet with an active ingredient pirfenidone. Pirfenidone is an anti-fibrotic drug used for the treatment of mild to moderate idiopathic pulmonary fibrosis.
Patient Information Leaflet (PIL)
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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 a medicine for the treatment of spinal muscular atrophy (SMA) that contains the active substances risdiplam. It is used to treat patients with SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies from the age of two months.
Evrysdi works by helping the body produce more survival motor neuron (SMN) protein. Which prevents the loss of motor neurons and may improve how well muscles work in people with SMA.
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Gavreto is a cancer medicine tablet used to treat adults with advanced states of a form of lung cancer called ‘non-small cell lung cancer’ (‘NSCLC’).
Gavreto is given as a monotherapy, which blocks (RET) fusion-positive advanced non-small cell lung cancer (NSCLC).
In patients whose cancer is due to an altered RET gene, the change in the gene causes the body to make an abnormal protein called a RET fusion protein, which can lead to uncontrolled cell growth and cancer. Gavreto blocks the action of RET fusion proteins and may help to slow or stop your lung cancer from growing. It may also help to shrink your cancer.
Patient Information Leaflet (PIL)
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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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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).
Patient Information Leaflet (PIL)
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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.
Patient Information Leaflet (PIL)
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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
Patient Information Leaflet (PIL)
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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: Non-Hodgkin’s Lymphoma (NHL); chronic lymphocytic leukaemia (CLL); rheumatoid arthritis; severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) or microscopic polyangiitis (MPA) and moderate to severe pemphigus vulgaris (PV). In children and adolescents, MabThera, in combination with chemotherapy, can be used for the treatment of some types of NHL and, in combination with corticosteroids, for the treatment of GPA and MPA.
MabThera is a humanised monoclonal antibody it contains the active ingredient Mabthera and it belongs to a group of medicines called monoclonal antibodies. Mabthera sticks to the surface of a type of white blood cell called "B-Lymphocyte". When Mabthera sticks to the surface of this cell, the cell dies.
MabThera is available as an intravenous (IV) and subcutaneous (SC) therapy.
In adults the IV formulation of MabThera is used for the treatment of Non-Hodgkin’s Lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis; severe, active granulomatosis with polyangiitis or microscopic polyangiitis (Wegener’s) and moderate to severe pemphigus vulgaris.
The IV formulation of MabThera can be used to treat to children and adolescents, from 6 months of age and older, with non-Hodgkin’s lymphoma, specifically CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).
The IV formulation of MabThera can also be used for treat children and adolescents, from 2 years of age and older, with granulomatosis with polyangiitis (formerly called Wegener’s granulomatosis) or microscopic polyangiitis.
Patient Information Leaflet (PIL)
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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.
Patient Information Leaflet (PIL)
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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.
Patient Information Leaflet (PIL)
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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.
Patient Information Leaflet (PIL)
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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.
Patient Information Leaflet (PIL)
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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.
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 thier growth, or kill them.
Usually pertuzumab and trastuzumab are given sequentially. Phesgo as a single treatment administers both pertuzumab and trastuzumab simultaneously.
Patient Information Leaflet (PIL)
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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.
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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.
Patient Information Leaflet (PIL)
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Roaccutane is used to treat patients with severe forms of acne.
Roaccutane is a tablet which contains active ingredient of isotretinoin – a substance related to vitamin A, and one of a group of medicines called retinoids (for treatment of acne).
Retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands in your skin, reducing bacteria and inflammation and opening clogged pores.
Therapy should be supervised by a dermatologist. Roaccutane is a possible teratogen (an agent or factor which causes malformation of an embryo). Female patients should be on the pregnancy prevention program whilst on Roaccutane therapy.
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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.
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RoActemra 20 mg/ml concentrate for solution for infusion .Patient Information Leaflet -
RoActemra 162 mg solution for injection in pre-filled syringe Patient Information Leaflet -
RoActemra 162 mg solution for injection in pre-filled pen
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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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.
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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.
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Tarceva is used for the treatment of patients with lung and pancreatic cancer.
Tarceva is a tablet that contains the active substance erlotinib. It belongs to a group of drug called tyrosine kinase inhibitors.
Tarceva is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells. When the ECFR protein has certain types of genetic mutations, Tarceva can interfere with these signals. This may cause the cancer cells to die.
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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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Vabysmo is a medicine for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME).
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.
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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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.
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▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this document. You can also report any side effects directly (see details below).
Please report side effects to:
The Drug Surveillance Centre
Roche Products (Ireland) Limited
Telephone:
Email:
Or report to:
HPRA Pharmacovigilance
Website:
M-IE-00001226 June 2022
Since our foundation in Basel, Switzerland in 1896, we at Roche have continually searched for better ways to prevent, diagnose and treat diseases. Our ongoing mission is to do now what patients need next.