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National expert: Mary O'Grady, Health Products Regulatory Authority (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 16.59 KB | PDF
Vitae PERSONAL INFORMATION Mary O'Grady WORK EXPERIENCE July 2007 … O'Grady 2020-12-07 Classified as … declaration of interests I, Mary O'Grady Organisation/Company: Health … -
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High-grade glioma expert group
London, UK, 03/12/2010, Last updated: 06/07/2011High-grade glioma expert group … High-grade glioma expert group … report on the paediatric high-grade glioma medicines expert workshop 7 … -
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Suitability of the graduation of delivery devices for liquid dosage forms
Last updated: 01/02/2005Suitability of the graduation of delivery devices for liquid … Suitability of the graduation of delivery devices for liquid … Guideline Suitability Graduation Delivery Devices …
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Direct healthcare professional communication (DHPC): Important information on Gliolan (5-aminolevulinic acid, 5-ALA): What to do in case of delayed surgery and information on fluorescence in non high-grade glioma
Active substance: 5-aminolevulinic acid hydrochloride, DHPC type: Type II variation, Last updated: 01/12/2020fluorescence in non high-grade glioma Glioma … fluorescence in non high-grade glioma … -
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Human medicine European public assessment report (EPAR): Methylthioninium chloride Proveblue
methylthioninium chloride, Methemoglobinemia
Date of authorisation: 06/05/2011, Revision: 22, Authorised, Last updated: 10/03/2020an atom of iron in the ‘ferrous’ form (Fe 2+ ). Exposure … converting them into the normal ferrous form. What benefits of Methylthioninium … an atom of iron in the ‘ferrous’ form (Fe2+). Exposure … -
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Veterinary medicine European public assessment report (EPAR): Palladia
toceranib, Dogs
Date of authorisation: 23/09/2009, Revision: 9, Authorised, Last updated: 19/05/2020are severe in character (grade 2 or 3), have come back … of non-resectable Patnaik grade-II (intermediate grade) or -III (high grade), recurrent, cutaneous mast-cell … are severe in character (grade 2 or 3), have come back … -
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Human medicine European public assessment report (EPAR): Zejula
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,
, 
, Revision: 11, Authorised, Last updated: 06/11/2020
involved women with high-grade epithelial ovarian cancer … women with advanced high-grade epithelial ovarian cancer … FIGO Stages III and IV) high-grade ovarian cancer. Recommendations … -
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Human medicine European public assessment report (EPAR): Mepact
mifamurtide, Osteosarcoma
Date of authorisation: 06/03/2009, Revision: 16, Authorised, Last updated: 17/06/2020Mepact is used to treat high-grade non-metastatic osteosarcoma … two and 30 years. ‘High-grade’ means that the cancer … one and 31 years with high-grade non-metastatic osteosarcoma … -
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Human medicine European public assessment report (EPAR): Lynparza
Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014, Revision: 12, Authorised, Last updated: 06/11/2020initial treatment of high-grade (fast-growing) cancers of … platinum-sensitive relapsed high-grade epithelial ovarian, fallopian … 1 cancers tend to be low-grade and indolent tumours and … -
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Human medicine European public assessment report (EPAR): Eladynos
abaloparatide, Osteoporosis
Date of refusal: 07/01/2019, Refused, Last updated: 14/02/2019is naturally broken down. Gradually, the bones become thin and … is naturally broken down. Gradually, the bones become thin and … is naturally broken down. Gradually, the bones become thin and … -
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Human medicine European public assessment report (EPAR): ChondroCelect
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins, Cartilage Diseases
Date of authorisation: 05/10/2009, Revision: 6, Withdrawn, Last updated: 12/01/2017Cartilage Repair Society [ICRS] grade III or IV) in adults. Concomitant … asymptomatic cartilage lesions (ICRS grade I or II) might be present … -
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Human medicine European public assessment report (EPAR): Vaniqa
Eflornithine, Hirsutism
Date of authorisation: 19/03/2001, Revision: 22, Authorised, Last updated: 15/04/2019the study by a doctor who graded the hirsutism as ‘clear … combined, a successful outcome (graded as ‘clear / almost clear’ … the study by a doctor who graded the hirsutism as ‘clear/almost … -
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Human medicine European public assessment report (EPAR): Lyrica
pregabalin, Epilepsy, Anxiety Disorders, Neuralgia
Date of authorisation: 05/07/2004, Revision: 48, Authorised, Last updated: 30/11/2020Lyrica should also be done gradually, over at least a week. The … Lyrica should also be done gradually, over at least a week. The … -
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Human medicine European public assessment report (EPAR): Pregabalin Pfizer
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 10/04/2014, Revision: 21, Authorised, Last updated: 27/11/2020Pfizer should also be done gradually, over at least a week. The … Pfizer should also be done gradually, over at least a week. The … -
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Human medicine European public assessment report (EPAR): Terrosa
teriparatide, Osteoporosis
Date of authorisation: 04/01/2017,, 
, Revision: 4, Authorised, Last updated: 28/10/2020
is naturally broken down. Gradually, the bones become less dense … is naturally broken down. Gradually, the bones become less dense … -
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Human medicine European public assessment report (EPAR): Evista
raloxifene hydrochloride, Osteoporosis, Postmenopausal
Date of authorisation: 05/08/1998, Revision: 23, Authorised, Last updated: 18/08/2020is naturally broken down. Gradually, the bones become thin and … is naturally broken down. Gradually, the bones become thin and … is naturally broken down. Gradually, the bones become thin and … -
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Orphan designation: 2-(2-{[2-(1H-benzimidazol-2-yl)ethyl]amino}ethyl)-N-[(3-fluoropyridine-2-yl)methyl]-1,3-oxazole-4-carboxamide trihydrochloride for: Treatment of beta-thalassaemia intermedia and major
Date of first decision: 28/06/2019, Positive, Last updated: 02/10/2019medicine blocks a protein, ferroportin, which transports iron from … -
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Human medicine European public assessment report (EPAR): Spherox
spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017,, Revision: 4, Authorised, Last updated: 29/06/2020
outcome score), which is graded on a scale of 0 to 100 (where … Cartilage Repair Society [ICRS] grade III or IV) with defect sizes … -
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Human medicine European public assessment report (EPAR): Axura
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 17/05/2002, Revision: 25, Authorised, Last updated: 05/11/2019dementia (a brain disorder) that gradually affects memory, intellectual … effects, the dose of Axura is gradually increased over the first … dementia (a brain disorder) that gradually affects memory, intellectual … -
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Human medicine European public assessment report (EPAR): Optruma
raloxifene hydrochloride, Osteoporosis, Postmenopausal
Date of authorisation: 05/08/1998, Revision: 23, Authorised, Last updated: 15/10/2019is naturally broken down. Gradually, the bones become thin and … is naturally broken down. Gradually, the bones become thin and … is naturally broken down. Gradually, the bones become thin and … -
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Human medicine European public assessment report (EPAR): Ebixa
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 15/05/2002, Revision: 25, Authorised, Last updated: 06/02/2019dementia (a brain disorder) that gradually affects memory, intellectual … effects, the dose of Ebixa is gradually increased over the first … dementia (a brain disorder) that gradually affects memory, intellectual … -
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Human medicine European public assessment report (EPAR): Raloxifene Teva (updated)
raloxifene hydrochloride, Osteoporosis, Postmenopausal
Date of authorisation: 29/04/2010,
, Revision: 9, Authorised, Last updated: 03/02/2021
is naturally broken down. Gradually, the bones become thin and … naturally broken down. Gradually, the bones become thin and … -
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Human medicine European public assessment report (EPAR): Targretin
bexarotene, Lymphoma, T-Cell, Cutaneous
Date of authorisation: 29/03/2001, Revision: 20, Authorised, Last updated: 09/07/2020measured by the doctor’s grading of improvement, as well as … according the doctor’s grading. The response rates according … EMA/234177/2018 Page 2/2 grading of improvement, as well as … -
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Human medicine European public assessment report (EPAR): Pramipexole Accord
pramipexole dihydrochloride monohydrate, Parkinson Disease, Restless Legs Syndrome
Date of authorisation: 29/09/2011,, Revision: 10, Authorised, Last updated: 11/12/2020
dose should be decreased gradually. For restless-legs syndrome … dose should be decreased gradually. Pramipexole Accord … -
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Human medicine European public assessment report (EPAR): Memantine LEK
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,
Date of refusal: 21/02/2013,, Revision: 5, Authorised, Last updated: 16/11/2020
dementia (a brain disorder) that gradually affects memory, intellectual … dose of Memantine LEK is gradually increased over the first … dementia (a brain disorder) that gradually affects memory, intellectual …