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Clinical evidence

Tremfya ▼ Receives Approval for Treatment of Moderate to Severe Plaque Psoriasis

Janssen is pleased to announce that Tremfya (guselkumab) is now available in Ireland for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.1 Guselkumab, a human IgG1l monoclonal antibody, is the first biologic that selectively blocks interleukin (IL)-23, a key driver of the immune inflammatory response in psoriasis. IL-23 affects the differentiation, expansion, ...

Brintellix (Vortioxetine) ▼ – Indicated for the Treatment of Major Depressive Episodes in Adults

Lundbeck is pleased to announce that Brintellix (vortioxetine), indicated for the treatment of major depressive episodes in adults, is now available in Ireland. It exhibits a unique, multimodal pharmacological profile, modulating serotonin receptor activity and inhibiting serotonin reuptake. Vortioxetine modulates neurotransmission in a number of systems, including predominantly the serotonin but probably also the noradrenaline, dopamine, histamine, acetylcholine, GABA and ...

Efficacy and Safety of Gazyvaro▼ for Treatment of Rituximab-Refractory Follicular Lymphoma

Roche is pleased to announce that Gazyvaro (obinutuzumab) is available in Ireland for the treatment of patients with previously treated follicular lymphoma (FL). Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to six months after treatment with rituximab or a ...

Stelara Receives Approval for Treatment of Moderately to Severely Active Crohn’s Disease

Janssen is pleased to announce that Stelara (ustekinumab) has received European approval for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist or have contraindications to such therapies. Stelara, a human monoclonal antibody, ...

Praxbind ▼ Approved for the Specific Reversal of the Anticoagulant Effects of Pradaxa

Download PDF Boehringer Ingelheim Ltd. is pleased to announce that Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding, is now available in Ireland. Idarucizumab is the first specific reversal agent for a novel oral anticoagulant (NOAC) to receive ...

Gazyvaro Now Available for Previously Untreated Chronic Lymphocytic Leukaemia

Download PDF Roche is pleased to announce that Gazyvaro (obinutuzumab) is now available in Ireland for people with previously untreated chronic lymphocytic leukaemia (CLL). Gazyvaro, in combination with chlorambucil chemotherapy, is indicated for the treatment of adult patients with previously untreated CLL who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy).1 CLL, which is characterised ...

Xigduo▼ (Dapagliflozin/Metformin) now Authorised in Ireland for Adults with Type 2 Diabetes

Download PDF                                        Forxiga▼ (dapagliflozin) was launched in Ireland in April 2014 and was the first medicine in the SGLT2 inhibitor class to gain marketing authorisation for the treatment of type 2 diabetes. AstraZeneca Pharmaceuticals (Ireland) Ltd is pleased to announce that Xigduo, which combines dapagliflozin and metformin in one tablet, is now available in Ireland. It is the first ...

New Indication for Xtandi▼ in Chemotherapy-Naïve Patients with Metastatic Castration-Resistant Prostate Cancer

Download PDF Astellas wish to announce that Xtandi has been approved for patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated. Although chemotherapy has been shown to improve overall and progression-free survival in men with metastatic prostate cancer, many patients do ...

Viekirax▼ and Exviera▼ Receive European Approval for Treatment of Chronic Hepatitis C Infection

Download PDF  AbbVie Ltd is pleased to announce that Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir), an interferon-free regimen, have been granted European approval for the treatment of patients with chronic hepatitis C virus (HCV) infection. The treatment has been approved with or without ribavirin for patients with genotype 1 chronic HCV infection, including those with compensated liver cirrhosis, HIV-1 co-infection, liver ...

Invokana ▼- Approved for Treatment of Type 2 Diabetes

Download PDF Janssen-Cilag Ltd. is pleased to announce that Invokana (canagliflozin) has received European approval for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control. Invokana is a member of a new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors contribute to controlling blood glucose levels via the kidney. As glucose ...