16401 results
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Opinion/decision on a Paediatric investigation plan (PIP): Sunvozertinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-003132-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 11/03/2022, Last updated: 20/04/2023, Compliance check: XKey facts Sunvozertinib OncologyP/0058/2022EMEA-003132-PIP01-21 … OncologyP/0058/2022EMEA-003132-PIP01-21 All pharmaceutical forms Treatment of non-small … administration Dizal (Jiangsu) Pharmaceutical Co., Ltd E-mail: info@dizalpharma.com … -
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Human medicine European public assessment report (EPAR): Sitagliptin SUN
sitagliptin fumarate, Diabetes Mellitus, Type 2
Date of authorisation: 09/12/2021,
, Revision: 1, Authorised, Last updated: 27/10/2022
Sitagliptin SUN Endocrine System Diseases Diabetes … Sitagliptin SUN is a medicine used to control … dose of insulin. Sitagliptin SUN contains the active substance … -
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,, Revision: 9, Authorised, Last updated: 09/02/2022
Atosiban SUN Obstetric Labor, Premature Obstetric … report (EPAR) for Atosiban SUN. It explains how the Agency … advice on how to use Atosiban SUN. For practical information … -
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Withdrawn application: Oportuzumab monatox DLRC Pharma Services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of withdrawal: 20/08/2021, Initial authorisation, Last updated: 20/10/2021Oportuzumab monatox DLRC Pharma Services: Withdrawn applicati … Oportuzumab monatox DLRC Pharma Services: Withdrawal of the … Oportuzumab monatox DLRC Pharma Services (oportuzumab monatox … -
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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Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
Zoledronic acid Teva Pharma Osteoporosis Osteitis Deformans Osteoporosis … for Zoledronic acid Teva Pharma has been withdrawn at the … documents Zoledronic acid Teva Pharma : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Rivastigmine 1 A Pharma
rivastigmine, Alzheimer Disease; Dementia; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 14, Authorised, Last updated: 13/10/2022Rivastigmine 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 … -
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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 … -
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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 … -
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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 … -
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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 … -
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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 … -
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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 … -
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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 … Ribavirin Teva and Ribavirin Teva Pharma B.V.) some of the studies … -
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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 … -
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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 … -
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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 … -
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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 … -
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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 … -
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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 … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.
clopidogrel (as hydrobromide), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 16/06/2011,, Revision: 4, Withdrawn, Last updated: 03/02/2015
Clopidogrel Teva Pharma B.V. Peripheral Vascular … Clopidogrel Teva Pharma B.V … Clopidogrel Teva Pharma B.V. withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG
tenecteplase, Myocardial Infarction
Date of authorisation: 23/02/2001, Revision: 2, Withdrawn, Last updated: 05/12/2005teplase Boehringer Ingelheim Pharma GmbH Co. KG Myocardial … teplase Boehringer Ingelheim Pharma GmbH Co. KG … TENECTEPLASE BOEHRINGER INGELHEIM PHARMA GmbH & Co. KG (tenecteplase … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
Budesonide, formoterol fumarate dihydrate, Asthma; Pulmonary Disease, Chronic Obstructive
Date of authorisation: 03/04/2020, Revision: 2, Authorised, Last updated: 08/12/2021Budesonide/Formoterol Teva Pharma B.V. Lung Diseases, Obstructive Lung … Budesonide/Formoterol Teva Pharma B.V … Budesonide/Formoterol Teva Pharma B.V. 160 micrograms / 4.5 … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
Budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017Budesonide/Formoterol Teva Pharma B.V. Asthma … Budesonide/Formoterol Teva Pharma B.V … Budesonide/Formoterol Teva Pharma B.V. Withdrawal of the marketing … -
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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: 1, Authorised, Last updated: 26/04/2022Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … or contact your doctor or pharmacist. How does Sibnayal work? Sibnayal … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Doxorubicin Sun (doxorubicin hydrochloride)
CHMP, Last updated: 21/07/2011Sun Pharmaceutical Industries Europe B.V. withdraws … application for Doxorubicin Sun (doxorubicin hydrochloride … been formally notified by Sun Pharmaceutical Industries Europe B.V. of …