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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Caelyx pegylated liposomal (updated)
doxorubicin hydrochloride, Sarcoma, Kaposi; Multiple Myeloma; Ovarian Neoplasms; Breast Neoplasms
Date of authorisation: 20/06/1996, Revision: 33, Authorised, Last updated: 24/05/2022 -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (updated)
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 8, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Ipique (updated)
bevacizumab, Wet Macular Degeneration
Date of refusal: 29/04/2022, Refused, Last updated: 24/05/2022 -
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Human medicine European public assessment report (EPAR): Pantozol Control (updated)
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 11/06/2009, Revision: 16, Authorised, Last updated: 24/05/2022 -
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Human medicine European public assessment report (EPAR): Somac Control (updated)
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 12/06/2009, Revision: 15, Authorised, Last updated: 24/05/2022 -
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Human medicine European public assessment report (EPAR): Controloc Control (updated)
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 11/06/2009, Revision: 14, Authorised, Last updated: 24/05/2022 -
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Human medicine European public assessment report (EPAR): Elaprase (updated)
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 23, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Trumenba (updated)
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal
Date of authorisation: 24/05/2017, Revision: 12, Authorised, Last updated: 24/05/2022 -
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 17, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Halaven (updated)
Eribulin, Breast Neoplasms; Liposarcoma
Date of authorisation: 17/03/2011, Revision: 27, Authorised, Last updated: 23/05/2022 -
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Human medicine European public assessment report (EPAR): Firdapse (previously Zenas) (updated)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,,
, Revision: 21, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Xolair (updated)
omalizumab, Asthma; Urticaria
Date of authorisation: 25/10/2005, Revision: 43, Authorised, Last updated: 23/05/2022 -
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Human medicine European public assessment report (EPAR): Rubraca (updated)
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,,
, Revision: 8, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan (updated)
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 15, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,,
, Revision: 19, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Zessly (updated)
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,,
, Revision: 9, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Keytruda (updated)
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015,, Revision: 45, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 13, Authorised, Last updated: 23/05/2022
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, Revision: 9, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Otezla (updated)
apremilast, Arthritis, Psoriatic; Psoriasis
Date of authorisation: 15/01/2015, Revision: 18, Authorised, Last updated: 20/05/2022 -
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Human medicine European public assessment report (EPAR): Rasilez HCT (updated)
aliskiren, hydrochlorothiazide, Hypertension
Date of authorisation: 16/01/2009, Revision: 17, Withdrawn, Last updated: 20/05/2022 -
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Human medicine European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop) (updated)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Withdrawn, Last updated: 20/05/2022