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Human medicine European public assessment report (EPAR): Glyxambi (updated)
empagliflozin, linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2016, Revision: 15, Authorised, Last updated: 25/05/2022 -
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Human medicine European public assessment report (EPAR): Synjardy (updated)
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015, Revision: 24, Authorised, Last updated: 25/05/2022 -
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Human medicine European public assessment report (EPAR): Lysodren (updated)
Mitotane, Adrenal Cortex Neoplasms
Date of authorisation: 28/04/2004, Revision: 17, Authorised, Last updated: 25/05/2022 -
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Human medicine European public assessment report (EPAR): Erbitux (updated)
cetuximab, Head and Neck Neoplasms; Colorectal Neoplasms
Date of authorisation: 29/06/2004, Revision: 29, Authorised, Last updated: 25/05/2022 -
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,,
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, Revision: 21, Authorised, Last updated: 25/05/2022
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Human medicine European public assessment report (EPAR): Aranesp (updated)
darbepoetin alfa, Anemia; Cancer; Kidney Failure, Chronic
Date of authorisation: 08/06/2001, Revision: 44, Authorised, Last updated: 25/05/2022 -
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Human medicine European public assessment report (EPAR): Nimenrix (updated)
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 20/04/2012, Revision: 35, Authorised, Last updated: 25/05/2022 -
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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: 25/05/2022
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Human medicine European public assessment report (EPAR): Velphoro (updated)
Sucroferric oxyhydroxide, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 26/08/2014, Revision: 9, Authorised, Last updated: 25/05/2022 -
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Human medicine European public assessment report (EPAR): Tecfidera (updated)
dimethyl fumarate, Multiple Sclerosis
Date of authorisation: 30/01/2014, Revision: 24, Authorised, Last updated: 25/05/2022 -
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Human medicine European public assessment report (EPAR): Amifampridine SERB (updated)
amifampridine phosphate, Lambert-Eaton Myasthenic Syndrome; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Neuromuscular Diseases; Neuromuscular Junction Diseases; Immune System Diseases; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Cancer; Neoplasms
Date of authorisation: 19/05/2022,, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Actos (updated)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2000, Revision: 29, Authorised, Last updated: 24/05/2022 -
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Human medicine European public assessment report (EPAR): Beovu (updated)
brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020,, Revision: 5, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Xeljanz (updated)
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013, Revision: 23, Authorised, Last updated: 24/05/2022 -
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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