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Number of results: 2900
Date Compound Product name Company Disease Action mechanism Type of Information
2018-09-20 fingolimod Gilenya® Novartis (Switzerland)
  • highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS.
sphingosine 1-phosphate receptor (S1PR) modulator. Gilenya®, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a new class of… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 tocilizumab Actemra®/Roactemra® Roche (Switzerland) Genentech (USA - CA) systemic juvenile idiopathic arthritis  (SJIA) monoclonal antibody. Actemra®/Roactemra® is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 enzalutamide Xtandi® Medivation (USA - CA), now Pfizer (USA - NY) Astellas (Japan)
  • patients with metastatic castration-resistant prostate cancer who have previously received docetaxel
  • adult men with high-risk non-metastatic castration-resistant prostate cancer
androgen receptor inhibitor. Xtandi® (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 eteplirsen Exondys 51® Sarepta Therapeutics (USA - MA) Duchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping antisense oligonucleotide. Eteplirsen is designed to address the underlying cause of DMD by enabling the production of a functional dystrophin protein. Eteplirsen… Negative opinion for the granting of a Market Authorisation in the EU
2018-09-20 adeno-associated viral vector type 2 expressing human recombinant retinal pigment epithelial 65KDa protein gene Luxturna™ (voretigene neparvovec-rzyl - SPK-RPE65) Spark Therapeutics (USA - PA) Novartis (Switzerland)
  • retinitis pigmentosa due to autosomal recessive RPE65 gene mutations
  • inherited retinal dystrophy due to biallelic RPE65 mutations
gene therapy. Voretigene neparvovec (SPK-RPE65) uses a neutralized virus as a vector, to transport a functional RPE65 gene into the affected… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 paclitaxel Paclical®/Apealea® Oasmia Pharmaceutical (Sweden)
  • epithelial ovarian cancer
  • primary peritoneal cancer
  • fallopian tube cancer
taxane derivative. Paclical®/Apealea® is a water-soluble formulation of Oasmia's patented non-toxic XR-17 technology and paclitaxel, one of the most widely… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 venetoclax Venclexta® (US)/Venclyxto® (UE) (venetoclax - RG7601, GDC-0199/ABT-199) Genentech, a member of Roche Group (USA - CA - Switzerland) AbbVie (USA -IL) chronic lymphocytic leukaemia (CLL) protein inhibitor/B-cell lymphoma 2 (BCL-2) inhibitor. Venetoclax (RG7601, GDC-0199/ABT-199 is an investigational small molecule designed to selectively bind and inhibit the… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 pegfilgrastim - biosimilar version of Neulasta® Ziextenzo® Sandoz (Switzerland) reduction of the duration of neutropenia and the occurrence of febrile neutropenia in cancer patients protein/biosimilar.Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF). Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 pegfilgrastim - biosimilar version of Neulasta® Fulphila® Mylan (USA - PA) Biocon (India)
  • reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)
protein/biosimilar. Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF). Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 brigatinib Alunbrig® (brigatinib - AP26113) Ariad Pharmaceuticals (USA - MA) now Takeda Pharmaceutical (Japan) patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib kinase inhibitor/tyrosine kinase inhibitor. Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at Ariad Pharmaceuticals. This protein kinase… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 mogamulizumab Poteligeo® (mogamulizumab) Kyowa Hakko Kirin (Japan) cutaneous T-cell lymphoma - mycosis fungoides - Sézary syndrome monoclonal antibody. Mogamulizumab is a novel, humanized mAb directed against CC chemokine receptor 4 (CCR4). Engineered by Kyowa Hakko Kirin's POTELLIGENT®… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 eravacycline Xerava® Tetraphase Pharmaceuticals (USA - MA) complicated intra-abdominal infections antibiotic. Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections. Eravacycline inhibits bacterial protein synthesis by… Granting of a Market Authorisation in the EU
2018-09-20 meropenem-vaborbactam Vabomere®, formerly known as Carbavance® Rempex Pharmaceuticals (USA - CA) Melinta Therapeutics (USA - CT) complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, ca used by specific bacteria antibiotic. Vabomere™ (formerly also known as Carbavance) is a fixed-dose combination of the carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam.… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 pegfilgrastim - biosimilar version of Neulasta® Pelmeg® - B12019 Cinfa Biotech (Spain) chemotherapy induced neutropenia protein/biosimilar. B12019, a biosimilar version of Neulasta® (pegfilgrastim), a pegylated form of the human granulocyte colony stimulating factor (G-CSF) analogue filgrastim. This granulocyte… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 cabozantinib Cabometyx™ Exelixis (USA - CA) Ipsen (France) hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib tyrosine kinase inhibitor.  Cabozantinib is a kinase inhibitor that blocks abnormal kinase proteins involved in the development and growth of… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 biosimilar version of adalimumab Humira® Hulio® Mylan (USA - PA) Fujifilm Kyowa Kirin Biologics (Japan)
  • rheumatoid arthritis
  • ankylosing spondylitis
  • axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
  • psoriatic arthritis
  • psoriasis
  • hidradenitis suppurativa
  • Crohn's disease
  • ulcerative colitis
  • uveitis
biosimilar/monoclonal antibody/TNF alpha inhibitor. Adalimumab is a monoclonal antibody that binds specifically to TNF alpha and blocks its interaction with  cell… Granting of a Market Authorisation in the EU
2018-09-20 encorafenib in combination with binimetinib and cetuximab Braftovi® in combination with Mektovi®and cetuximab Array BioPharma (USA - CO) Pierre Fabre Médicament (France)
  • BRAFV600E-mutant metastatic colorectal cancer (mCRC)
kinase inhibitor/RAF kinase inhibitor/MEK (MAP kinase) inhibitor. The RAS/RAF/MEK/ERK pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis.… Granting of a Market Authorisation in the EU
2018-09-20 doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) Delstrigo™ (doravirine / lamivudine / tenofovir disoproxil fumarate)/Pifeltro™ (doravirine) Merck&Co (USA - NJ) HIV-1 infection in adults non-nucleoside reverse transcriptase inhibitor (NNRTI). Doravirine is an investigational non-nucleoside reverse transcriptase inhibitor being evaluated for the treatment of HIV-1 infection.… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 galcanezumab Emgality® Eli Lilly (USA -IN) prevention of migraine in adults monoclonal antibody. Galcanezumab (LY2951742) is a once-monthly subcutaneously injected calcitonin gene-related peptide (CGRP) antibody currently being studied as a potential… Positive opinion for the granting of a Market Authorisation in the EU
2018-09-20 buprenorphine Buvidal® (CAM2038) Camurus (Sweden) opioid dependence opioid agonist/antagonist. Buprenorphine is used in addictive disorders and act as an opioid partial agonist/antagonist. CAM2038 weekly and monthly buprenorphine injection… Positive opinion for the granting of a Market Authorisation in the EU