18284 results
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Human medicine European public assessment report (EPAR): Sarclisa (updated)
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,
, Revision: 1, Authorised, Last updated: 17/05/2021
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Human medicine European public assessment report (EPAR): Tasigna (updated)
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 40, Authorised, Last updated: 17/05/2021 -
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,, 
, Revision: 7, Authorised, Last updated: 17/05/2021
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Orphan designation: Palovarotene for: Treatment of multiple osteochondromas (updated)
Date of first decision: 27/06/2018, Positive, Last updated: 17/05/2021 -
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News: More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine (new)
CHMP, Last updated: 17/05/2021 -
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COVID-19: latest updates (updated)
Last updated: 17/05/2021 -
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Human medicine European public assessment report (EPAR): Buccolam (updated)
midazolam, Epilepsy
Date of authorisation: 04/09/2011, Revision: 12, Authorised, Last updated: 17/05/2021 -
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Human medicine European public assessment report (EPAR): Remsima (updated)
infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,
, Revision: 23, Authorised, Last updated: 17/05/2021
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine Moderna (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, , Revision: 3, Authorised, Last updated: 17/05/2021
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Human medicine European public assessment report (EPAR): Vokanamet (updated)
canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/04/2014, Revision: 18, Authorised, Last updated: 17/05/2021 -
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News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 2021 (new)
CVMP, Last updated: 17/05/2021 -
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Summary of opinion: Bonqat (new)
pregabalin, opinion date: 12/05/2021, Positive, Last updated: 17/05/2021 -
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Human medicine European public assessment report (EPAR): Enurev Breezhaler (updated)
glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 28/09/2012, Revision: 9, Authorised, Last updated: 17/05/2021 -
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Human medicine European public assessment report (EPAR): Yuflyma (updated)
adalimumab, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease, Arthritis, Juvenile Rheumatoid, Hidradenitis Suppurativa, Uveitis
Date of authorisation: 11/02/2021,, Revision: 2, Authorised, Last updated: 17/05/2021
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Human medicine European public assessment report (EPAR): Rekovelle (updated)
follitropin delta, Anovulation
Date of authorisation: 12/12/2016,, Revision: 3, Authorised, Last updated: 17/05/2021
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Human medicine European public assessment report (EPAR): Sildenafil Actavis (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,
, Revision: 14, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Zubsolv (updated)
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 6, Authorised, Last updated: 12/05/2021 -
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
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, Revision: 28, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Memantine Mylan (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 7, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Aclasta (updated)
zoledronic acid, Osteoporosis, Osteitis Deformans, Osteoporosis, Postmenopausal
Date of authorisation: 15/04/2005, Revision: 28, Authorised, Last updated: 12/05/2021 -
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Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,, Revision: 41, Authorised, Last updated: 12/05/2021
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Paediatric Committee (PDCO): 23-26 March 2021 (updated)
Virtual meeting, from 23/03/2021 to 26/03/2021, Last updated: 12/05/2021 -
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Human medicine European public assessment report (EPAR): Orgalutran (updated)
ganirelix, Reproductive Techniques, Assisted, Ovulation Induction
Date of authorisation: 16/05/2000, Revision: 22, Authorised, Last updated: 12/05/2021 -
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Human medicine European public assessment report (EPAR): Axura (updated)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 17/05/2002, Revision: 25, Authorised, Last updated: 12/05/2021 -
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Human medicine European public assessment report (EPAR): Fosavance (updated)
alendronic acid, colecalciferol, Osteoporosis, Postmenopausal
Date of authorisation: 24/08/2005, Revision: 25, Authorised, Last updated: 12/05/2021