19740 results
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/07/2016,
, Revision: 13, Authorised, Last updated: 27/07/2022
Pemetrexed Fresenius Kabi Cancer Neoplasms Carcinoma … report (EPAR) for Pemetrexed Fresenius Kabi. It explains how the Agency assessed … the medicine to recommend its authorisation in the EU and … -
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,, Revision: 9, Authorised, Last updated: 18/05/2021
Busulfan Fresenius Kabi Cancer Neoplasms Stem … report (EPAR) for Busulfan Fresenius Kabi. It explains how the Agency assessed … the medicine to recommend its authorisation in the EU and … -
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 5, Authorised, Last updated: 01/09/2021
Bortezomib Fresenius Kabi Hemostatic Disorders Vascular … Bortezomib Fresenius Kabi is a medicine used to treat … these patients, Bortezomib Fresenius Kabi is used in combination with … -
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Human medicine European public assessment report (EPAR): Sugammadex Fresenius Kabi
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/07/2022,, Authorised, Last updated: 21/07/2022
Sugammadex Fresenius Kabi Anesthesia and Analgesia Investigative … sugammadex Overview Sugammadex Fresenius Kabi is a medicine used to reverse … breathe. Muscle relaxants make it easier for the surgeon to … -
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Direct healthcare professional communication (DHPC): Briviact® (In Italy: Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck diameter
Active substance: Brivaracetam, DHPC type: Quality defect, Last updated: 20/12/2021Briviact® (In Italy: Nubriveo®) (brivaracetam … Oral solution: Bottles with narrow neck diameter Epilepsy … Briviact® (In Italy: Nubriveo®) (brivaracetam … -
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Opinion/decision on a Paediatric investigation plan (PIP): Propan-2-yl (2S)-2-{[(S)-({(2R,3R,4R,5R)-5-[2-amino-6-(methylamino)-9H-purin-9-yl]-4-fluoro-3- hydroxy-4-methyloxolan-2-yl}methoxy)(phenoxy)phosphoryl]amino}propanoate; sulfuric acid (2:1) (AT-527 / RO7496998)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002963-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Tablet
Decision date: 29/10/2021, Last updated: 20/02/2023, Compliance check: Xsulfuric acid (2:1) (AT-527 / RO7496998) Therapeutic area Infectious … number EMEA-002963-PIP01-21 Pharmaceutical form(s) Age-appropriate oral … for public enquiries Atea Pharmaceuticals, Inc. Email: Dept-regulatory@ateapharma.com … -
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Orphan designation: Heparin-binding epidermal growth factor-like growth factor, amino acids 74-148 for: Prevention of necrotising enterocolitis
Date of designation: 31/10/2006, Positive, Last updated: 13/01/2014immune system (the body's natural defence system) of these … If the disease progresses, it can lead to peritonitis and … factor (HB-EGF), amino acids 74-148 is a part of protein … -
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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 … Refused natalizumab Overview On 19 July 2007 … for the medicinal product Natalizumab Elan Pharma concentrate for solution … -
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
Docetaxel Kabi Cancer Neoplasms Breast … Docetaxel Kabi is a cancer medicine used … breast cancer. Docetaxel Kabi can be used on its own after other treatments … -
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Orphan designation: Ecteinascidin 743 (trabectedin) for: Treatment of soft tissue sarcoma
Date of designation: 30/05/2001, Expired, Last updated: 03/10/2017the European Commission to Pharma Mar SA, Spain, for ecteinascidin … Spain, for ecteinascidin 743 for the treatment of soft … tissue sarcoma. Ecteinascidin 743 in treatment of soft tissue … -
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Human medicine European public assessment report (EPAR): Briviact (in Italy: Nubriveo)
Brivaracetam, Epilepsy
Date of authorisation: 13/01/2016, Revision: 21, Authorised, Last updated: 04/04/2023Briviact (in Italy: Nubriveo) Nervous System … specific part of the brain). It can be used in patients from … leaflet or contact a doctor or pharmacist. How does Briviact work? Epilepsy … -
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Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000332-PIP01-08-M16, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Solution for injection
Decision date: 09/04/2021, Last updated: 18/01/2022, Compliance check: XInvented name Briviact (in Italy: Nubriveo) Active substance … EMEA-000332-PIP01-08-M16 Pharmaceutical form(s) Film-coated tablet … for public enquiries UCB Pharma S.A. E-mail: UCBCares.IE@ucb.com … -
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Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000332-PIP01-08-M15, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Solution for injection
Decision date: 12/08/2020, Last updated: 28/06/2021, Compliance check: XInvented name Briviact (in Italy: Nubriveo) QG01AA01 Active … EMEA-000332-PIP01-08-M15 Pharmaceutical form(s) Film-coated tablet … for public enquiries UCB Pharma S.A. E-mail: UCBCares.IE@ucb.com … -
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Veterinary medicine European public assessment report (EPAR): Fungitraxx
Itraconazole, Avian
Date of authorisation: 12/03/2014, Revision: 2, Authorised, Last updated: 27/03/2019Authorised itraconazole Overview This is a summary … Public Assessment Report. Its purpose is to explain how … contains the active substance itraconazole. … -
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Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000332-PIP02-17-M03, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Solution for injection
Decision date: 18/01/2022, Last updated: 05/04/2023, Compliance check: XKey facts Briviact (in Italy: Nubriveo) Brivaracetam NeurologyP/0003/2022EMEA-000332-PIP02-17-M03 … Oral use Intravenous use UCB Pharma S.A. Tel. + 353 14632371 … EMA/782280/2021 Generic Briviact (in Italy: Nubriveo): EPAR Briviact (in … -
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Orphan designation: 8-[4-(1-Aminocyclobutyl)phenyl]-9-phenyl-1,2,4-triazolo[3,4-f][1,6]naphthyridin-3(2H)-one mono-hydrochloride for: Treatment of ovarian cancer
Date of designation: 30/11/2009, Withdrawn, Last updated: 21/02/2019with ovarian cancer because it works in a different way … experimental models indicate that it might improve the treatment … -
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Orphan designation: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline for: Treatment of tuberculosis
Date of designation: 26/08/2005, Positive, Last updated: 01/04/2014European Commission to Tibotec Pharmaceuticals Ltd., Ireland, for (1R,2S … bacteria called Mycobacterium . It spreads from person to person … tuberculosis mainly because it might improve the long-term … -
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,
, Revision: 24, Authorised, Last updated: 03/03/2023
Techniques and Procedures Physical Examination Body Constitution Body … and Measures Body Size Physiological Phenomena Obesity Overweight … Authorised naltrexonebupropion Overview This is a summary … -
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Orphan designation: Adeno-associated virus serotype rh74 containing the human micro-dystrophin gene for: Treatment of Duchenne muscular dystrophy
Date of designation: 28/02/2020, Positive, Last updated: 22/10/2020adeno-associated virus serotype rh74 containing the human micro-dystrophin … atrophy (wasting) of muscles. It mainly affects boys, and … life threatening because of its effects on the heart and … -
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Referral: Prokanazol
itraconazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/04/2009, EC decision date: 14/07/2009, Last updated: 06/08/2009Recommendation provided by Pharmacovigilance Risk Assessment Committee … Prokanazol do not outweigh its risks, and that the marketing … is an antifungal medicine. It is used to treat adults with … -
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Opinion/decision on a Paediatric investigation plan (PIP): Itacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002178-PIP01-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet, Age-appropriate oral solid dosage form
Decision date: 06/12/2019, Last updated: 02/04/2020, Compliance check: XKey facts Itacitinib Immunology-Rheumatology-TransplantationP/0414/2019EMEA-002178-PIP01-17-M01 … globalmedinfo@incyte.com Tel. +800 0002 7423 PM: decision on the application … paediatric investigation plan for itacitinib (EMEA-002178-PIP01-17-M01 … -
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Orphan designation: Itraconazole for: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome)
Date of designation: 23/08/2017, Positive, Last updated: 13/10/2021European Commission to Mayne Pharma UK Limited, United Kingdom … Limited, United Kingdom, for itraconazole for the treatment of naevoid basal-cell carcinoma syndrome … Consulting S.A.R.L. changed name to Voisin Consulting Life … -
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Orphan designation: Adeno-associated virus serotype rh74 containing the human sarcoglycan beta gene for: Treatment of limb-girdle muscular dystrophy
Date of designation: 09/12/2020, Positive, Last updated: 19/05/2021adeno-associated virus serotype rh74 containing the human sarcoglycan … life-threatening condition because it causes progressive muscle … Adeno-associated virus serotype rh74 containing the human sarcoglycan … -
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Orphan designation: Itolizumab for: Treatment of graft-versus-host disease
Date of designation: 19/07/2021, Positive, Last updated: 12/11/2021was transferred to Biocon Pharma Malta I Limited, Malta in … medicine is expected to work Itolizumab is a monoclonal antibody … meet a number of criteria: it must be intended for the … -
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Orphan designation: N-{2-Chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N'-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate for: Treatment of renal-cell carcinoma
Date of designation: 09/06/2010, Withdrawn, Last updated: 17/05/2017EU/3/10/747 … orphan designation (EU/3/10/747) was granted by the European … European Commission to Aveo Pharma Ltd, United Kingdom, for …