19718 results
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … infants are immature and not as well developed as full term infants'. In particular … lead to complications such as gut perforation, sepsis and … -
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 17, Withdrawn, Last updated: 06/03/2023
Temozolomide Sandoz Cancer Neuroectodermal … Embryonal Neoplasms Neoplasms, Nerve Tissue Astrocytoma Glioma Glioma Glioblastoma … details Name Temozolomide Sandoz Agency product number EMEA/H/C/001128 … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … Overview On 08 April 2015, Sandoz GmbH officially notified … human medicines. Abbreviated as CHMP. More information … -
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Human medicine European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 11/11/2013, Revision: 10, Authorised, Last updated: 16/01/2023Levodopa/Carbidopa/Entacapone Sandoz) Nervous System Diseases Neurodegenerative … Levodopa/Carbidopa/Entacapone Sandoz) : EPAR - All Authorised presentations … DDC) inhibitor treatment. Assessment history Changes since initial … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 17, Authorised, Last updated: 22/11/2023
Pregabalin Sandoz Mental Disorders Nervous … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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Human medicine European public assessment report (EPAR): Rivastigmine Sandoz
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 14, Authorised, Last updated: 25/09/2023Rivastigmine Sandoz Nervous System Diseases Central … summary of the European public assessment report (EPAR). It explains … Products for Human Use (CHMP) assessed the studies performed, to … -
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 9, Authorised, Last updated: 01/09/2022
Aripiprazole Sandoz Schizophrenia Spectrum and … summary of the European public assessment report (EPAR) for Aripiprazole … report (EPAR) for Aripiprazole Sandoz. It explains how the Agency assessed the medicine to recommend … -
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Human medicine European public assessment report (EPAR): Clopidogrel Sandoz
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 2, Withdrawn, Last updated: 26/10/2011
Clopidogrel Sandoz Peripheral Vascular Diseases Stroke Myocardial … details Name Clopidogrel Sandoz Agency product number EMEA/H/C/001174 … developed to be the same as a medicine that has already … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 16, Withdrawn, Last updated: 12/10/2023
Pregabalin Sandoz GmbH Mental Disorders Nervous … Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults … developed to be the same as a medicine that has already … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2 … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … -
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Human medicine European public assessment report (EPAR): Pemetrexed Sandoz
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/09/2015,, Revision: 7, Authorised, Last updated: 27/07/2022
Pemetrexed Sandoz Carcinoma, Bronchogenic Bronchial … summary of the European public assessment report (EPAR) for Pemetrexed Sandoz. It explains how the Agency assessed the medicine to recommend … developed to be the same as a medicine that has already … -
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 9, Authorised, Last updated: 06/07/2022
Ibandronic Acid Sandoz Skin and Connective Tissue … summary of the European public assessment report (EPAR) for Ibandronic … EPAR) for Ibandronic Acid Sandoz. It explains how the Committee … -
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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 2, Authorised, Last updated: 30/06/2023Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … used? Sibnayal is available as prolonged-release granules … -
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Human medicine European public assessment report (EPAR): Sycrest
asenapine (as maleate) , Bipolar Disorder
Date of authorisation: 01/09/2010, Revision: 21, Authorised, Last updated: 07/12/2022asenapine … Sycrest, INN-asenapine EMA/675530/2015 EMEA/H/C/001177 … for the public Sycrest asenapine This is a summary of the … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with medicines for the treatment … immunodeficiency virus (HIV) infection. As a result, HIV medicines will … -
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,
, Revision: 4, Authorised, Last updated: 07/07/2023
Insulin aspart Sanofi Glucose Metabolism … Authorised insulin aspart Overview Insulin aspart Sanofi is a medicine used … who have diabetes. Insulin aspart Sanofi is a ‘ A medicine … -
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 43, Authorised, Last updated: 29/11/2023Authorised abacavir (as sulfate) / lamivudine / zidovudine … Trizivir. Trizivir is available as tablets (300 mg abacavir/150 mg … medicine for end-users, such as patients and animal owners … -
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Human medicine European public assessment report (EPAR): Spectrila (updated)
asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 6, Authorised, Last updated: 20/11/2023Authorised asparaginase Overview This is a summary … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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Human medicine European public assessment report (EPAR): Scemblix
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,
, 
, Revision: 3, Authorised, Last updated: 22/09/2023
Authorised asciminib Overview Scemblix is a cancer … The medicine is available as tablets to be taken by mouth … medicine for end-users, such as patients and animal owners … -
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Human medicine European public assessment report (EPAR): NovoMix
insulin aspart, Diabetes Mellitus
Date of authorisation: 01/08/2000, Revision: 29, Authorised, Last updated: 29/08/2023Authorised insulin aspart Overview NovoMix is a range … active substance insulin aspart (100 units/ml) combined with … longer acting. It is available as: NovoMix 30 (30% insulin … -
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Human medicine European public assessment report (EPAR): NovoRapid
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 32, Authorised, Last updated: 22/03/2023Active substance insulin aspart International non-proprietary … INN) or common name insulin aspart Therapeutic area (MeSH) Diabetes … Marketing-authorisation holder Novo Nordisk A/S Revision 32 Date of issue … -
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , 
, Revision: 16, Authorised, Last updated: 15/02/2023
Authorised asfotase alfa Overview Strensiq is … medicine. active substance asfotase alfa. Hypophosphatasia is … The medicine is available as a solution for injection … -
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Human medicine European public assessment report (EPAR): Fiasp
insulin aspart, Diabetes Mellitus
Date of authorisation: 09/01/2017, Revision: 8, Authorised, Last updated: 23/09/2021Active substance insulin aspart International non-proprietary … INN) or common name insulin aspart Therapeutic area (MeSH) Diabetes … Marketing-authorisation holder Novo Nordisk A/S Revision 8 Date of issue … -
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 4, Authorised, Last updated: 01/12/2023
Authorised insulin aspart Overview Kirsty is a medicine … active substance insulin aspart. How is Kirsty used? Kirsty … prescription. It is given as an injection under the skin … -
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Human medicine European public assessment report (EPAR): Truvelog Mix 30
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022,, , Revision: 2, Authorised, Last updated: 06/07/2023
Authorised insulin aspart Overview Truvelog Mix 30 … active substance insulin aspart combined with protamine to … prescription and is given as an injection under the skin …