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22/12/2018 Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid, 07/09/2003, 70, Authorised
20/12/2018 Human medicines European public assessment report (EPAR): Simponi, Golimumab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Arthritis, Rheumatoid, 01/10/2009, 32, Authorised
20/12/2018 Minutes: Minutes of the PRAC meeting 29-31 October 2018
20/12/2018 Human medicines European public assessment report (EPAR): Moventig, naloxegol oxalate, Constipation, Opioid-Related Disorders, 07/12/2014, Additional monitoring, 8, Authorised
20/12/2018 Veterinary medicines European public assessment report (EPAR): Imrestor, Pegbovigrastim, 09/12/2015, 1, Authorised
20/12/2018 Human medicines European public assessment report (EPAR): Odomzo, sonidegib diphosphate, Carcinoma, Basal Cell, 14/08/2015, Additional monitoring, 6, Authorised
20/12/2018 Other: Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities
20/12/2018 Human medicines European public assessment report (EPAR): Ivabradine JensonR, ivabradine hydrochloride, Angina Pectoris, Heart Failure, 11/11/2016, Generic, Withdrawn
20/12/2018 Scientific guideline: Concept paper on a guideline for allergen products development in moderate to low-sized study populations
20/12/2018 Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt for the: Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive