199 results
Keyword Allergan Remove keyword
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National expert: Valgerdur Gudrun Gunnarsdottir, Icelandic Medicines Agency (updated)
- Declaration of interests - 39.47 KB | PDF
- Curriculum Vitae - 26.87 KB | PDF
Actavis group (including Allergan & Teva) • Start date … Maintaining oversight of Allergan global stability programs … -
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Referral: Botox
Clostridium botulinum type A neurotoxin complex, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/02/2003, EC decision date: 25/06/2003, Last updated: 16/10/2003Marketing Authorisation Holder, Allergan Pharmaceuticals (Ireland … Marketing Authorisation Holder, Allergan Pharmaceuticals (Ireland … -
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National expert: Dagný Sigurbjörg Jónsdóttir, Icelandic Medicines Agency (updated)
- Declaration of interests - 39.69 KB | PDF
- Curriculum Vitae - 27.76 KB | PDF
Activities: Actavis Group PTC ehf./Allergan (Iceland) Responsible as … -
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National expert: Teresa Casanovas, European Medicines Agency (updated)
- Declaration of interests - 41.23 KB | PDF
- Curriculum Vitae - 24.73 KB | PDF
Genfit, Ipsen, AstraZeneca, Allergan, Novartis, Adaptimmune, Bayer … -
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Orphan designation: Recombinant adeno-associated viral vector serotype 5 encoding Staphylococcus aureus Cas9 endonuclease and two guide RNAs complementary to two regions of intron 26 of the CEP290 gene for: Treatment of Leber's congenital amaurosis
Date of designation: 16/10/2017, Positive, Last updated: 30/11/2020sponsorship was transferred to Allergan Pharmaceuticals International … -
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National expert: Inés Contreras, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 41.54 KB | PDF
- Curriculum Vitae - 40.19 KB | PDF
lectures and advisory boards Allergan null Fees for lectures and … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014
CHMP, Last updated: 25/07/2014Marketing-authorisation applicant Allergan Pharmaceuticals Ireland More … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 March 2006
CHMP, Last updated: 24/03/2006bimatoprost/timolol), Allergan Pharmaceuticals Ireland … Ganfort (bimatoprost/timolol), Allergan Pharmaceuticals Ireland … -
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Human medicine European public assessment report (EPAR): Constella (updated)
linaclotide, Irritable Bowel Syndrome
Date of authorisation: 26/11/2012, Revision: 25, Authorised, Last updated: 24/05/2023 -
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Human medicine European public assessment report (EPAR): Ozurdex
dexamethasone, Macular Edema; Uveitis
Date of authorisation: 26/07/2010, Revision: 18, Authorised, Last updated: 20/07/2022this medicinal product is Allergan Pharmaceuticals Ireland … this medicinal product is Allergan Pharmaceuticals Ireland … -
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Human medicine European public assessment report (EPAR): Ganfort
bimatoprost, timolol, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 19/05/2006, Revision: 23, Authorised, Last updated: 20/07/2022 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
CHMP, Last updated: 20/07/2012application/pdf Ozurdex dexamethasone Allergan Pharmaceuticals Ireland … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 17-20 May 2010
CHMP, Last updated: 21/05/2010dexamethasone), from Allergan Pharmaceuticals Ireland … Ozurdex (dexamethasone), from Allergan Pharmaceuticals Ireland … -
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Human medicine European public assessment report (EPAR): Zinforo
Ceftaroline fosamil, Community-Acquired Infections; Skin Diseases, Infectious; Pneumonia
Date of authorisation: 22/08/2012, Revision: 26, Authorised, Last updated: 22/07/2022 -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 April 2011
CHMP, Last updated: 15/04/2011dexamethasone), from Allergan Pharmaceuticals Ireland … Ozurdex (dexamethasone), from Allergan Pharmaceuticals Ireland … -
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Withdrawn application: Opsiria
sirolimus, date of withdrawal: 20/05/2016, Initial authorisation, Last updated: 30/09/2016 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020Marketing-authorisation applicant Allergan Pharmaceuticals International … -
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National expert: Janos Porszasz, National Institute of Pharmacy and Nutrition (updated)
- Declaration of interests - 42.36 KB | PDF
- Curriculum Vitae - 251.5 KB | PDF
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018
CHMP, Last updated: 01/06/2018Marketing-authorisation applicant Allergan Pharmaceuticals International … -
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Referral: Retinoid-containing medicinal products
acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene, associated names: Targretin, Panretin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/03/2018, EC decision date: 21/06/2018, Last updated: 02/07/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Truberzi, Eluxadoline
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001579-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Brazikumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001929-PIP01-16, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 19/12/2017, Last updated: 21/01/2021, Compliance check: Xdecision is addressed to Allergan Limited, Marlow International … name of the PIP applicant: Allergan Limited Opinion of the … -
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Support for industry on clinical data publication
Last updated: 25/04/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2023 -
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PDCO: Agendas, minutes and reports
Last updated: 24/04/2023