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Human medicine European public assessment report (EPAR): Bronchitol (updated)
mannitol, Cystic Fibrosis
Date of authorisation: 13/04/2012, Revision: 19, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Optison (updated)
perflutren, Echocardiography
Date of authorisation: 17/05/1998, Revision: 19, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Rozlytrek (updated)
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,,
, Revision: 4, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Forxiga (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2012, Revision: 25, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Edistride (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Date of authorisation: 09/11/2015, Revision: 20, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Kiovig (updated)
human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome
Date of authorisation: 18/01/2006, Revision: 26, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Vocabria (updated)
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 5, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Ozempic (updated)
semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018,, Revision: 8, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Votubia (updated)
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,, Revision: 30, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Afinitor (updated)
everolimus, Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms
Date of authorisation: 02/08/2009, Revision: 30, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Xalkori (updated)
crizotinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 23/10/2012, Revision: 32, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 25, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Azacitidine Mylan (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 4, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 17, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Accofil (updated)
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 13, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Sapropterin Dipharma (updated)
Sapropterin dihydrochloride, Phenylketonurias
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 12, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan (updated)
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 13, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Libmeldy (updated)
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,,
, Revision: 4, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Sildenafil ratiopharm (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 23/12/2009,, Revision: 19, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Efmody (updated)
hydrocortisone, Adrenal Hyperplasia, Congenital
Date of authorisation: 27/05/2021, Revision: 2, Authorised, Last updated: 24/06/2022 -
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Human medicine European public assessment report (EPAR): Cosentyx (updated)
Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing
Date of authorisation: 14/01/2015, Revision: 27, Authorised, Last updated: 24/06/2022 -
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Human medicine European public assessment report (EPAR): Imatinib Accord (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 23, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): LysaKare (updated)
L-arginine hydrochloride, L-lysine hydrochloride, Radiation Injuries
Date of authorisation: 25/07/2019, Revision: 2, Authorised, Last updated: 23/06/2022 -
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Human medicine European public assessment report (EPAR): Erleada (updated)
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 7, Authorised, Last updated: 23/06/2022