16696 results
-
List item
Referral: Escitalopram
escitalopram, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/02/2010, Last updated: 29/09/2010Escitalopram … Recommendation provided by Pharmacovigilance Risk Assessment Committee … review of a group of generic escitalopram-containing medicines that were authorised … -
List item
Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005Recommendation provided by Pharmacovigilance Risk Assessment Committee … citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … -
List item
Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,
, Revision: 16, Authorised, Last updated: 08/09/2023
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Schizophrenia Spectrum and … EPAR) for Aripiprazole Mylan Pharma. It explains how the Agency … to use Aripiprazole Mylan Pharma. For practical information … -
List item
Orphan designation: lonapegsomatropin for: Treatment of growth hormone deficiency
Date of designation: 17/10/2019, Positive, Last updated: 17/02/2022European Commission to Ascendis Pharma Endocrinology Division A/S … Lonapegsomatropin Ascendis Pharma since 11 January 2022. Expand … Lonapegsomatropin Ascendis Pharma) Skytrofa (previously Lonapegsomatropin … -
List item
Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (updated)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,
, 
, Revision: 4, Authorised, Last updated: 06/11/2023
Lonapegsomatropin Ascendis Pharma) Growth and Development … Lonapegsomatropin Ascendis Pharma) … Lonapegsomatropin Ascendis Pharma (lonapegsomatropin) An … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
previously Clopidogrel Taw Pharma) Vascular Diseases Cardiovascular … previously Clopidogrel Taw Pharma) … known as Clopidogrel Mylan Pharma and subsequently as Clopidogrel … -
List item
Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015Recommendation provided by Pharmacovigilance Risk Assessment Committee … INN Invented name Strength Pharmaceutical Form Route of administration … INN Invented name Strength Pharmaceutical Form Route of administration … -
List item
Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the marketing … market exclusivity under pharmaceutical legislation (typically 10 … -
List item
Withdrawn application: Lacosamide Pain UCB Pharma
lacosamide, date of withdrawal: 25/09/2008, Initial authorisation, Last updated: 26/09/2008Lacosamide Pain UCB Pharma: Withdrawn application … for Lacosamide Pain UCB Pharma International non-proprietary … On 25 September 2008, UCB Pharma S.A. officially notified … -
List item
Withdrawn application: Oportuzumab monatox DLRC Pharma Services
oportuzumab monatox, date of withdrawal: 20/08/2021, Initial authorisation, Last updated: 20/10/2021Oportuzumab monatox DLRC Pharma Services: Withdrawn applicati … Oportuzumab monatox DLRC Pharma Services: Withdrawal of the … Oportuzumab monatox DLRC Pharma Services (oportuzumab monatox … -
List item
Human medicine European public assessment report (EPAR): Rivastigmine 1 A Pharma
rivastigmine, Alzheimer Disease; Dementia; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 15, Authorised, Last updated: 21/06/2023Rivastigmine 1 A Pharma Nervous System Diseases Central … or contact your doctor or pharmacist. If you want more information … What is Rivastigmine 1 A Pharma? Rivastigmine 1 A Pharma is a medicine containing … -
List item
Human medicine European public assessment report (EPAR): Telmisartan Teva Pharma
Telmisartan, Hypertension
Date of authorisation: 03/10/2011,, Revision: 10, Authorised, Last updated: 26/10/2021
Telmisartan Teva Pharma Cardiovascular Diseases Vascular … Telmisartan Teva Pharma … market exclusivity under pharmaceutical legislation (typically 10 … -
List item
Human medicine European public assessment report (EPAR): Pregabalin Mylan Pharma
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 25/06/2015,, Revision: 7, Withdrawn, Last updated: 26/04/2022
Pregabalin Mylan Pharma Mental Disorders Nervous … authorisation for Pregabalin Mylan Pharma has been withdrawn at the … documents Pregabalin Mylan Pharma : EPAR - Summary for the … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel 1A Pharma
clopidogrel, Peripheral Vascular Diseases
Date of authorisation: 28/07/2009,, Revision: 1, Withdrawn, Last updated: 28/02/2011
Clopidogrel 1A Pharma Peripheral Vascular Diseases … Clopidogrel 1A Pharma … to the same company, Acino Pharma GmbH, and they all contain … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Acino Pharma
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 1, Withdrawn, Last updated: 26/07/2012
Clopidogrel Acino Pharma Peripheral Vascular Diseases Stroke Myocardial … Clopidogrel Acino Pharma … statement Clopidogrel Acino Pharma (clopidogrel) Withdrawal … -
List item
Human medicine European public assessment report (EPAR): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Date of authorisation: 21/01/2011,, Revision: 6, Withdrawn, Last updated: 21/01/2014
Docetaxel Teva Pharma Carcinoma, Non-Small-Cell … Docetaxel Teva Pharma … statement on Docetaxel Teva Pharma 7 Westferry Circus … -
List item
Human medicine European public assessment report (EPAR): Natalizumab Elan Pharma
natalizumab, Crohn Disease
Date of refusal: 11/01/2008, Refused, Last updated: 25/01/2008Natalizumab Elan Pharma Crohn Disease … product Natalizumab Elan Pharma concentrate for solution … for authorisation is Elan Pharma International Ltd. The applicant … -
List item
Human medicine European public assessment report (EPAR): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,, Revision: 14, Withdrawn, Last updated: 09/07/2021
Ribavirin Teva Pharma B.V. Hepatitis C, Chronic … Ribavirin Teva Pharma B.V … Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … -
List item
Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 19, Authorised, Last updated: 21/04/2023
Lamivudine Teva Pharma B.V. Blood-Borne Infections Communicable … Lamivudine Teva Pharma B.V … market exclusivity under pharmaceutical legislation (typically 10 … -
List item
Human medicine European public assessment report (EPAR): Pioglitazone Teva Pharma
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 13, Withdrawn, Last updated: 30/08/2022
Pioglitazone Teva Pharma Nutritional and Metabolic … Pioglitazone Teva Pharma … market exclusivity under pharmaceutical legislation (typically 10 … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Acino Pharma GmbH
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 1, Withdrawn, Last updated: 26/07/2012
Clopidogrel Acino Pharma GmbH Peripheral Vascular … Clopidogrel Acino Pharma GmbH … Clopidogrel Acino Pharma GmbH Public Statement … -
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
Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Vascular … Clopidogrel Taw Pharma (previously Clopidogrel Mylan … market exclusivity under pharmaceutical legislation (typically 10 … -
List item
Human medicine European public assessment report (EPAR): Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)
Telmisartan, Hypertension
Date of authorisation: 16/12/1998, Revision: 30, Authorised, Last updated: 18/12/2020Telmisartan Boehringer Ingelheim Pharma KG) Cardiovascular Diseases Vascular … Telmisartan Boehringer Ingelheim Pharma KG … Telmisartan Boehringer Ingelheim Pharma KG) telmisartan Telmisartan … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
Zoledronic acid Teva Pharma Osteoporosis Osteitis Deformans Osteoporosis … for Zoledronic acid Teva Pharma has been withdrawn at the … documents Zoledronic acid Teva Pharma : EPAR - Summary for the … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma (previously Clopidogrel HCS)
clopidogrel (as hydrochloride), Myocardial Infarction; Peripheral Vascular Diseases; Stroke
Date of authorisation: 21/09/2009,, Revision: 9, Withdrawn, Last updated: 24/10/2017
Clopidogrel Teva Pharma (previously Clopidogrel HCS) Myocardial … Clopidogrel Teva Pharma (previously Clopidogrel HCS … statement Clopidogrel Teva Pharma Withdrawal of the marketing …