16395 results
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,
, Revision: 15, Authorised, Last updated: 12/01/2023
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Schizophrenia Spectrum and … Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) … market exclusivity under pharmaceutical legislation (typically 10 … -
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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 Diseases Cardiovascular … Overview Clopidogrel Taw Pharma is a medicine used to prevent … attack). Clopidogrel Taw Pharma can be started between a … -
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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Date of authorisation: 25/06/2015,, Revision: 7, Withdrawn, Last updated: 26/04/2022
Pregabalin Mylan Pharma Mental Disorders Nervous … authorisation for Pregabalin Mylan Pharma has been withdrawn at the … Summary documents Pregabalin Mylan Pharma : EPAR - Summary for the … -
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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: 02/12/2003Recommendation provided by Pharmacovigilance Risk Assessment Committee … Commission final decision Overview Enalapril is a highly specific, competitive … the benefit/risk ratio of enalapril is considered to be favourable … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate) (updated)
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 … failure Oral use Proveca Pharma Limited Tel. +353 15136233 … paediatric investigation plan for enalapril (maleate) (EMEA-001706-PIP01-14-M03 … -
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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 … of hypertension Oral use Pharmathen S.A. Greece E-mail: mkalovidouri@pharmathen.com … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … -
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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 … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … -
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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 … or contact your doctor or pharmacist. How does Clopidogrel Viatris … Clopidogrel Viatris Clopidogrel Mylan Pharma received a The approval to … -
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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 … -
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,
, 
, Revision: 3, Authorised, Last updated: 31/01/2023
Lonapegsomatropin Ascendis Pharma) Growth and Development … Lonapegsomatropin Ascendis Pharma is a medicine that is used … Lonapegsomatropin Ascendis Pharma was designated an ‘ A medicine … -
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Human medicine European public assessment report (EPAR): Sugammadex Mylan
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/11/2021,, Revision: 1, Authorised, Last updated: 03/10/2022
Sugammadex Mylan Protective Agents Specialty … Uses Physiological Effects of Drugs Pharmacologic Actions Neuromuscular Blocka … sugammadex Overview Sugammadex Mylan is a medicine used to reverse … -
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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 … -
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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 … -
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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): 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 … hypertension (atenolol, lisinopril, enalapril and amlodipine). The main … or contact your doctor or pharmacist. List item … -
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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 … EPAR) for Telmisartan Teva Pharma. It explains how the The committee … use for Telmisartan Teva Pharma. What is Telmisartan Teva Pharma? Telmisartan Teva Pharma is a medicine that contains … -
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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 … authorisation for Clopidogrel 1A Pharma has been withdrawn at the … documents Clopidogrel 1A 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 … authorisation for Clopidogrel Acino Pharma has been withdrawn at the … documents Clopidogrel Acino Pharma : EPAR - Summary for the … -
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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): 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): 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): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 18, Authorised, Last updated: 18/01/2022
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): 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): 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 … authorisation for Clopidogrel Acino Pharma GmbH has been withdrawn at … documents Clopidogrel Acino Pharma GmbH : EPAR - Summary for …