42 results
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Press release: Bausch & Lomb Ireland withdraws its marketing authorisation application for Retisert
Last updated: 23/07/2007Bausch & Lomb Ireland withdraws … been formally notified by Bausch & Lomb Ireland of its decision … EMEA/331932/2007 PRESS RELEASE Bausch & Lomb Ireland withdraws … -
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Orphan designation: Fluocinolone acetonide for: Treatment of non-infectious uveitis affecting the posterior segment of the eye
Date of designation: 07/03/2005, Positive, Last updated: 30/05/2007the European Commission to Bausch & Lomb (UK) Ltd, United Kingdom … sponsorship was transferred to Bausch & Lomb Ireland in October … the European Commission to Bausch & Lomb (UK) Ltd, United Kingdom … -
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Opinion/decision on a Paediatric investigation plan (PIP): brimonidine
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Ophthalmology
PIP number: EMEA-002558-PIP01-19, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Eye drops, solution
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: Xhyperaemia Ophthalmic use Bausch Health Ireland Limited Tel … -
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Human medicine European public assessment report (EPAR): Yellox
bromfenac sodium sesquihydrate, Pain, Postoperative; Ophthalmologic Surgical Procedures
Date of authorisation: 18/05/2011, Revision: 10, Authorised, Last updated: 23/11/2020Marketing-authorisation holder Bausch Health Ireland Limited Revision … -
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Human medicine European public assessment report (EPAR): Relistor
methylnaltrexone bromide, Opioid-Related Disorders; Constipation
Date of authorisation: 01/07/2008, Revision: 17, Authorised, Last updated: 28/01/2021Marketing-authorisation holder Bausch Health Ireland Limited Revision … -
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National expert: Agnieszka Wlazly, Chief Pharmaceutical Inspectorate
- Declaration of interests - 80.69 KB | PDF
- Curriculum Vitae - 16.83 KB | PDF
R&D Emo-Farm Sp. z o.o. / Bausch Health (Poland) Research … Indication 01/2018-03/2019 Emo-Farm Sp. z o.o. / Bausch Health Cross product responsibility … -
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National expert: Kheira Hamadi, National Agency For The Safety Of Medicine And Health Products
- Declaration of interests - 80.39 KB | PDF
- Curriculum Vitae - 16.62 KB | PDF
calibration Manager Chauvin Bausch & Lomb (France) EDUCATION … -
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National expert: Thomas M RICHTER, Federal Institute for Drugs and Medical Devices
- Declaration of interests - 81.19 KB | PDF
- Curriculum Vitae - 17.51 KB | PDF
Scientist (Group Leader) Bausch & Lomb (Dr. Mann Pharma … -
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National expert: Anna Mari Lone, Norwegian Medicines Agency
- Declaration of interests - 80.54 KB | PDF
- Curriculum Vitae - 19.63 KB | PDF
Type of Interest Declared Bausch Health My husband holds a … -
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National expert: ANTONIOS TSARBOPOULOS, National Organization for Medicines
- Declaration of interests - 79.85 KB | PDF
- Curriculum Vitae - 42.31 KB | PDF
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Human medicine European public assessment report (EPAR): Mysimba (updated)
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,
, Revision: 21, Authorised, Last updated: 19/05/2022
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National expert: Claudio Cerchione, European Medicines Agency
- Declaration of interests - 79.89 KB | PDF
- Curriculum Vitae - 80.9 KB | PDF
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National expert: Jochen Seufert, European Medicines Agency
- Declaration of interests - 82.48 KB | PDF
- Curriculum Vitae - 48.99 KB | PDF
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Withdrawn application: Retisert
date of withdrawal: 16/07/2007, Initial authorisation, Last updated: 23/07/2007acetonide On 16 July 2007, Bausch & Lomb Ireland officially … -
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National expert: Reinier Schlingemann, European Medicines Agency
- Declaration of interests - 83.86 KB | PDF
- Curriculum Vitae - 56.37 KB | PDF
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Orphan designation: Tobramycin for: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of designation: 17/03/2003, Positive, Last updated: 01/07/2019 -
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Orphan designation: fosfomycin disodium, Tobramycin for: Treatment of cystic fibrosis
Date of designation: 10/08/2015, Positive, Last updated: 02/10/2015 -
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Orphan designation: Tobramycin for: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of designation: 11/04/2006, Withdrawn, Last updated: 14/03/2013 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018multiplex kezelése Italian Desametasone (compressa da 40 mg) Trattamento … -
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Orphan designation: Dexamethasone phosphate for: Treatment of corneal graft rejection
Date of designation: 15/05/2009, Withdrawn, Last updated: 21/10/2016 -
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Orphan designation: dexamethasone for: Treatment of non-infectious uveitis affecting the posterior segment of the eye
Date of designation: 04/08/2010, Withdrawn, Last updated: 19/11/2010 -
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Orphan designation: Dexamethasone sodium phosphate encapsulated in human erythrocytes for: Treatment of cystic fibrosis
Date of designation: 20/10/2004, Positive, Last updated: 22/02/2010 -
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Public data from Article 57 database
Last updated: 02/06/2021 -
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EudraVigilance: electronic reporting
Last updated: 15/02/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 22-25 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 22/03/2021 to 25/03/2021, Last updated: 07/12/2021