5120 results
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Opinion/decision on a Paediatric investigation plan (PIP): Finasteride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-001878-PIP01-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous spray, Solution
Decision date: 15/04/2016, Last updated: 02/06/2016, Compliance check: XActive substance Finasteride Therapeutic area Dermatology … product specific waiver for finasteride (EMEA-001878-PIP01-15) in … product specific waiver for finasteride (EMEA-001878-PIP01-15) in … -
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Withdrawn application: Fingolimod Mylan
fingolimod, date of withdrawal: 08/05/2020, Initial authorisation, Last updated: 17/06/2020Fingolimod Mylan: Withdrawn application … Fingolimod Mylan Fingolimod Mylan fingolimod fingolimod hydro … -
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Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018Rotigotine Mylan: Withdrawn application … application for Rotigotine Mylan (rotigotine) On 22 December … On 22 December 2017, Mylan SAS officially notified the … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 08/01/2016, Initial authorisation, Last updated: 29/03/2016Aripiprazole Mylan: Withdrawn application … application for Aripiprazole Mylan (aripiprazole) On 8 January … aripiprazole) On 8 January 2016, Mylan S.A.S. officially notified … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015Aripiprazole Mylan: Withdrawn application … application for Aripiprazole Mylan (aripiprazole) On 7 May … authorisation for Aripiprazole Mylan, for the treatment of schizophrenia … -
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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … application for Docetaxel Mylan (docetaxel) On 8 March … docetaxel) On 8 March 2010, Mylan S.A.S. officially notified … -
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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 … Docetaxel Mylan … 1 Public statement Docetaxel Mylan Cessation of validity of … -
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Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 1, Authorised, Last updated: 21/06/2019
Gefitinib Mylan Carcinoma, Non-Small-Cell … Gefitinib Mylan … authorisation) Gefitinib Mylan gefitinib On 26 July 2018 … -
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Human medicine European public assessment report (EPAR): Zonisamide Mylan
zonisamide, Epilepsy
Date of authorisation: 31/03/2016,, Revision: 5, Authorised, Last updated: 14/01/2021
Zonisamide Mylan Epilepsy … Zonisamide Mylan … Zonisamide Mylan, INN-zonisamide 30 … -
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Human medicine European public assessment report (EPAR): Duloxetine Mylan
duloxetine, Neuralgia, Diabetic Neuropathies, Anxiety Disorders, Depressive Disorder, Major
Date of authorisation: 19/06/2015,, Revision: 13, Authorised, Last updated: 18/11/2020
Duloxetine Mylan Neuralgia Diabetic Neuropathies Anxiety … Duloxetine Mylan … for the public Duloxetine Mylan duloxetine This is a summary … -
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 8, Authorised, Last updated: 08/12/2020
Ritonavir Mylan HIV Infections … Ritonavir Mylan … for the public Ritonavir Mylan ritonavir This is a summary … -
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Human medicine European public assessment report (EPAR): Fulvestrant Mylan
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 4, Authorised, Last updated: 15/10/2020
Fulvestrant Mylan Breast Neoplasms … Fulvestrant Mylan … Fulvestrant Mylan; INN-fulvestrant 30 … -
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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: 1, Authorised, Last updated: 16/09/2020
Azacitidine Mylan Myelodysplastic Syndromes Leukemia … Azacitidine Mylan … Azacitidine Mylan azacitidine azacitidine … -
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Human medicine European public assessment report (EPAR): Febuxostat Mylan
febuxostat, Hyperuricemia, Arthritis, Gouty, Gout
Date of authorisation: 15/06/2017,, Revision: 4, Authorised, Last updated: 18/05/2020
Febuxostat Mylan Hyperuricemia Arthritis … Febuxostat Mylan … Febuxostat Mylan, INN - febuxostat … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 24/06/2015,, Revision: 8, Authorised, Last updated: 16/04/2020
Pregabalin Mylan Anxiety Disorders Epilepsy … Pregabalin Mylan … Pregabalin Mylan,INN-pregabalin 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 11, Authorised, Last updated: 17/01/2020
Tadalafil Mylan Erectile Dysfunction … Tadalafil Mylan … Tadalafil Mylan, INN-tadalafil 30 … -
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Human medicine European public assessment report (EPAR): Olanzapine Mylan
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 15, Authorised, Last updated: 09/10/2019
Olanzapine Mylan Schizophrenia Bipolar Disor … Olanzapine Mylan … REPORT (EPAR) OLANZAPINE MYLAN EPAR summary for the public … -
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 1, Authorised, Last updated: 20/03/2020
Ambrisentan Mylan Hypertension, Pulmonary … Ambrisentan Mylan … Ambrisentan Mylan ambrisentan ambrisentan … -
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 3, Authorised, Last updated: 25/02/2021
Entecavir Mylan Hepatitis B … PDF/16.85 KB) (PDF/16.85 KB) Italian (PDF/15.75 KB) (PDF/15.75 … Therapeutic indication Entecavir Mylan is indicated for the treatment … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan Pharma (updated)
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 25/06/2015,, Revision: 7, Authorised, Last updated: 02/02/2021
Pregabalin Mylan Pharma Anxiety Disorders Ne … Pregabalin Mylan Pharma … for the public Pregabalin Mylan Pharma pregabalin This … -
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Withdrawn application: Alendronic Acid / Colecalciferol Mylan
date of withdrawal: 27/05/2016, Initial authorisation, Last updated: 02/02/2017dronic Acid / Colecalciferol Mylan: Withdrawn application … Alendronic Acid/Colecalciferol Mylan (alendronic acid and colecalciferol … colecalciferol) On 27 May 2016, Mylan SAS officially notified the … -
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Human medicine European public assessment report (EPAR): Cinacalcet Mylan
cinacalcet hydrochloride, Hyperparathyroidism, Secondary, Hypercalcemia
Date of authorisation: 19/11/2015,, Revision: 9, Authorised, Last updated: 10/12/2020
Cinacalcet Mylan Hyperparathyroidism, Seconda … PDF/27.93 KB) (PDF/27.93 KB) Italian (PDF/28.16 KB) (PDF/28.16 … dialysis therapy. Cinacalcet Mylan may be used as part of a … -
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 2, Authorised, Last updated: 08/06/2020
Anagrelide Mylan Thrombocythemia, Essential … Anagrelide Mylan … for the public Anagrelide Mylan anagrelide This is a summary … -
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Human medicine European public assessment report (EPAR): Rasagiline Mylan
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 3, Authorised, Last updated: 25/05/2020
Rasagiline Mylan Parkinson Disease … Rasagiline Mylan … Summary for Rasagiline Mylan 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Memantine Mylan
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 6, Authorised, Last updated: 24/04/2020
Memantine Mylan Alzheimer Disease … Memantine Mylan … Memantine Mylan, INN-memantine EMA/136420/2013 …