7873 results
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin (calcium trihydrate), Indapamide, perindopril arginine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002395-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/10/2018, Last updated: 29/01/2019, Compliance check: Xatorvastatin (calcium trihydrate) Indapamide perindopril arginine Therapeutic … statin (calcium trihydrate) Indapamide perindopril arginine … -
List item
Withdrawn application: Fingolimod Mylan
fingolimod, date of withdrawal: 08/05/2020, Initial authorisation, Last updated: 17/06/2020Fingolimod Mylan: Withdrawn application … Fingolimod Mylan Fingolimod Mylan fingolimod fingolimod hydro … -
List item
Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,
, Revision: 15, Authorised, Last updated: 01/06/2023
Tadalafil Mylan Mental Disorders Sexual … report (EPAR) for Tadalafil Mylan. It explains how the Agency … advice on how to use Tadalafil Mylan. For practical information … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid, indapamide (hemihydrate), perindopril tert-butylamine, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002366-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 12/09/2018, Last updated: 18/01/2019, Compliance check: Xsubstance Acetylsalicylic acid indapamide (hemihydrate) perindopril … Acetylsalicylic acid indapamide (hemihydrate) perindopril … -
List item
Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 6, Authorised, Last updated: 27/07/2023
Gefitinib Mylan Cancer Neoplasms Respiratory … gefitinib Overview Gefitinib Mylan is a cancer medicine used … receptor (EGFR). Gefitinib Mylan contains the The substance … -
List item
Human medicine European public assessment report (EPAR): Olanzapine Mylan
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 19, Authorised, Last updated: 14/07/2023
Olanzapine Mylan Schizophrenia Spectrum and … EPAR). What is Olanzapine Mylan? Olanzapine Mylan is a medicine containing … 15 and 20 mg). Olanzapine Mylan is a ‘ A generic medicine is a medicine that … -
List item
Human medicine European public assessment report (EPAR): Duloxetine Mylan
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 18, Authorised, Last updated: 25/08/2023
Duloxetine Mylan Nervous System Diseases Neuromuscular … report (EPAR) for Duloxetine Mylan. It explains how the Agency … on how to use Duloxetine Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 4, Authorised, Last updated: 26/04/2023
Ambrisentan Mylan Lung Diseases Respiratory … ambrisentan Overview Ambrisentan Mylan is a medicine that is used … of the lungs. Ambrisentan Mylan is used in patients with … -
List item
Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 9, Authorised, Last updated: 08/06/2023
Zonisamide Mylan Brain Diseases Central … report (EPAR) for Zonisamide Mylan. It explains how the Agency … on how to use Zonisamide Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Febuxostat Mylan
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,, Revision: 11, Authorised, Last updated: 16/05/2023
Febuxostat Mylan Pathological Conditions … report (EPAR) for Febuxostat Mylan. It explains how the Agency … on how to use Febuxostat Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Fulvestrant Mylan
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 5, Authorised, Last updated: 24/02/2023
Fulvestrant Mylan Neoplasms Cancer Breast … report (EPAR) for Fulvestrant Mylan. It explains how the Agency … on how to use Fulvestrant Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Deferasirox Mylan
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 9, Authorised, Last updated: 28/03/2023
Deferasirox Mylan Nutritional and Metabolic … deferasirox Overview Deferasirox Mylan is a medicine used to treat … from the gut. Deferasirox Mylan contains the The substance … -
List item
Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 16, Authorised, Last updated: 13/01/2023
Pregabalin Mylan Mental Disorders Nervous … report (EPAR) for Pregabalin Mylan. It explains how the Agency … on how to use Pregabalin Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Lenalidomide Mylan
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Revision: 8, Authorised, Last updated: 12/07/2023
Lenalidomide Mylan Cancer Neoplasms Neoplasms … lymphocytes, Lenalidomide Mylan is used in adults whose disease … with rituximab. Lenalidomide Mylan contains the active substance … -
List item
Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 14, Authorised, Last updated: 17/05/2023
Ritonavir Mylan Blood-Borne Infections Communicable … report (EPAR) for Ritonavir Mylan. It explains how the Agency … advice on how to use Ritonavir Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 5, Authorised, Last updated: 22/02/2023
Azacitidine Mylan Bone Marrow Diseases Hematologic … Azacitidine Mylan is used for the treatment … myeloid cells). Azacitidine Mylan is used in patients with … -
List item
Human medicine European public assessment report (EPAR): Teriflunomide Mylan
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Revision: 1, Authorised, Last updated: 16/01/2023
Teriflunomide Mylan Multiple Sclerosis Demyelinating … Teriflunomide Mylan is a medicine used to treat … themselves. Teriflunomide Mylan is used in the type of MS … -
List item
Human medicine European public assessment report (EPAR): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 13, Authorised, Last updated: 23/05/2023
Darunavir Mylan Blood-Borne Infections Communicable … report (EPAR) for Darunavir Mylan. It explains how the Agency … advice on how to use Darunavir Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Docetaxel Mylan
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 31/01/2012,, Revision: 6, Withdrawn, Last updated: 12/03/2015
Docetaxel Mylan Head and Neck Neoplasms Carcinoma … oduct details Name Docetaxel Mylan Agency product number EMEA/H/C/002317 … chemical (ATC) code L01CD02 Generic Generic Generic This is a … -
List item
Human medicine European public assessment report (EPAR): Sugammadex Mylan
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/11/2021,, Revision: 2, Authorised, Last updated: 21/06/2023
Sugammadex Mylan Protective Agents Specialty … sugammadex Overview Sugammadex Mylan is a medicine used to reverse … the operation. Sugammadex Mylan is used to speed up the recovery … -
List item
Human medicine European public assessment report (EPAR): Fingolimod Mylan
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 4, Authorised, Last updated: 02/05/2023
Fingolimod Mylan Multiple Sclerosis, Relapsin … fingolimod Overview Fingolimod Mylan is a medicine used to treat … remissions). Fingolimod Mylan is used when the disease … -
List item
Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 8, Authorised, Last updated: 11/05/2023
Anagrelide Mylan Cancer Neoplasms Blood … report (EPAR) for Anagrelide Mylan. It explains how the Agency … on how to use Anagrelide Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Memantine Mylan
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 10, Authorised, Last updated: 29/03/2023
Memantine Mylan Nervous System Diseases Central … report (EPAR) for Memantine Mylan. It explains how the Agency … advice on how to use Memantine Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Rasagiline Mylan
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 7, Authorised, Last updated: 23/02/2023
Rasagiline Mylan Nervous System Diseases Central … report (EPAR) for Rasagiline Mylan. It explains how the Agency … on how to use Rasagiline Mylan. For practical information … -
List item
Human medicine European public assessment report (EPAR): Cinacalcet Mylan
cinacalcet hydrochloride, Hyperparathyroidism, Secondary; Hypercalcemia
Date of authorisation: 19/11/2015,, Revision: 15, Authorised, Last updated: 26/04/2023
Cinacalcet Mylan Nutritional and Metabolic … report (EPAR) for Cinacalcet Mylan. It explains how the Agency … on how to use Cinacalcet Mylan. For practical information …