7515 results
-
List item
Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,
, Revision: 7, Authorised, Last updated: 09/06/2022
lmanco (previously Tadalafil Generics) Respiratory Tract Diseases Lung … lmanco (previously Tadalafil Generics) … Questions and answers on generic medicines What is a generic medicine? A generic medicine is a medicine that … -
List item
Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn application … Pioglitazone Teva Generics: Withdrawal of the marketing … authorisation) Pioglitazone Teva Generics pioglitazone On 22 September … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis; Osteitis Deformans
Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016
Zoledronic acid Teva Generics Osteoporosis Osteitis Defor … for Zoledronic Acid Teva Generics has been withdrawn at the … documents Zoledronic acid Teva Generics : EPAR - Summary for the … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
Clopidogrel Teva Generics B.V. Peripheral Vascular … authorisation for Clopidogrel Teva Generics B.V. has lapsed because it … documents Clopidogrel Teva Generics B.V. : EPAR - Summary for … -
List item
Referral: Renitec
enalapril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/09/2002, EC decision date: 21/05/2003, Last updated: 02/12/2003Commission final decision Overview Enalapril is a highly specific, competitive … the benefit/risk ratio of enalapril is considered to be favourable … Non-Proprietary Name (INN): enalapril: Background information an … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001706-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form
Decision date: 17/03/2021, Last updated: 09/03/2023, Compliance check: V, 25/06/2021Key facts Enalapril (maleate) Cardiovascular … paediatric investigation plan for enalapril (maleate) (EMEA-001706-PIP01-14-M03 … 05/11/2021 EMA/94579/2021 Generic Topics: Paediatrics … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001241-PIP02-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 03/09/2014, Last updated: 29/09/2014, Compliance check: XKey facts Enalapril (maleate) Cardiovascular … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … 29/09/2014 EMA/468294/2014 Generic Topics: Paediatrics … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001516-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet for oral suspension, Orodispersible film
Decision date: 05/05/2014, Last updated: 06/06/2014, Compliance check: XKey facts Enalapril (maleate) Cardiovascular … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … 06/06/2014 EMA/235549/2014 Generic Topics: Paediatrics … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
clopidogrel hydrochloride, Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 21/09/2009,, Revision: 20, Authorised, Last updated: 01/07/2022
Pharma (previously Clopidogrel Mylan) Vascular Diseases Cardiovascular … clopidogrel and is a ‘ A generic medicine is a medicine that … company can only market a generic medicine once the 10-year … -
List item
Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015Aripiprazole Mylan: Withdrawn application … zole Overview On 7 May 2015, Generics (UK) Limited officially notified … authorisation for Aripiprazole Mylan, for the treatment of schizophrenia … -
List item
Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018Rotigotine Mylan: Withdrawn application … Overview On 22 December 2017, Mylan SAS officially notified the … authorisation for Rotigotine Mylan, for the treatment of Parkinson's … -
List item
Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … Overview On 8 March 2010, Mylan S.A.S. officially notified … authorisation for Docetaxel Mylan intended to be used to treat … -
List item
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 … -
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
Withdrawn application: Alendronic Acid / Colecalciferol Mylan
date of withdrawal: 27/05/2016, Initial authorisation, Last updated: 02/02/2017dronic Acid / Colecalciferol Mylan: Withdrawn application … Overview On 27 May 2016, Mylan SAS officially notified the … Alendronic Acid/Colecalciferol Mylan, for the treatment of postmenopausal … -
List item
Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 14, Authorised, Last updated: 30/06/2022
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
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): Darunavir Mylan (updated)
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): Ritonavir Mylan (updated)
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): Febuxostat Mylan (updated)
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): 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): 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): 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): Rivaroxaban Mylan
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 2, Authorised, Last updated: 21/04/2023
Rivaroxaban Mylan Cardiovascular Diseases Vascular … rivaroxaban Overview Rivaroxaban Mylan is an anticoagulant medicine … with aspirin. Rivaroxaban Mylan contains the The substance … -
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 …