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25 results
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Summary of opinion: Azacitidine Mylan (updated)
azacitidine, opinion date: 30/01/2020, Positive, Last updated: 04/02/2020 -
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Summary of opinion: Rubraca
rucaparib, opinion date: 13/12/2018, Positive, Last updated: 14/12/2018 -
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Summary of opinion: Deferasirox Accord
deferasirox, opinion date: 14/11/2019, Positive, Last updated: 15/11/2019 -
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Summary of opinion: Azacitidine Accord
azacitidine, opinion date: 12/12/2019, Positive, Last updated: 13/12/2019 -
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Summary of opinion: Ervebo
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), opinion date: 17/10/2019, Positive, Last updated: 18/10/2019 -
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Summary of opinion: Adcetris
brentuximab vedotin, opinion date: 13/12/2018, Positive, Last updated: 14/12/2018 -
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Summary of opinion: Arsenic trioxide Mylan
arsenic trioxide, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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Summary of opinion: Cinacalcet Accordpharma
cinacalcet, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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Summary of opinion: Azacitidine betapharm
azacitidine, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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Summary of opinion: Sirturo
bedaquiline, opinion date: 12/12/2019, Positive, Last updated: 13/12/2019 -
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Orphan designation: for: Treatment of diffuse large B-cell lymphoma (updated)
Date of first decision: 16/04/2018, Positive, Last updated: 27/01/2020 -
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Orphan designation: for: Treatment of peripheral T-cell lymphoma
Date of first decision: 21/09/2019, Positive, Last updated: 16/01/2020 -
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Orphan designation: for: Treatment of beta thalassaemia intermedia and major
Date of first decision: 24/01/2013, Positive, Last updated: 03/06/2019 -
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Orphan designation: for: Treatment of familial chylomicronaemia syndrome
Date of first decision: 19/02/2014, Positive, Last updated: 20/05/2019 -
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Orphan designation: for: Treatment of X-linked hypophosphataemia
Date of first decision: 15/10/2014, Positive, Last updated: 22/10/2018 -
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Orphan designation: for: Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns
Date of first decision: 07/11/2008, Positive, Last updated: 09/02/2018 -
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Orphan designation: for: Treatment of cutaneous T-cell lymphoma
Date of first decision: 11/01/2012, Positive, Last updated: 01/02/2018 -
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Orphan designation: for: Treatment of hypoparathyroidism
Date of first decision: 16/01/2014, Positive, Last updated: 26/04/2017 -
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Orphan designation: for: Treatment of primary biliary cirrhosis
Date of first decision: 27/07/2010, Positive, Last updated: 19/12/2016 -
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Orphan designation:
Date of first decision: 15/01/2009, Positive, Last updated: 13/05/2015 -
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Orphan designation: for: Treatment of multiple myeloma
Date of first decision: 27/09/2011, Positive, Last updated: 13/05/2015 -
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Orphan designation: for: Treatment of Duchenne muscular dystrophy
Date of first decision: 27/05/2005, Positive, Last updated: 10/03/2015 -
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Orphan designation: for: Treatment of tuberculosis
Date of first decision: 02/02/2008, Positive, Last updated: 18/06/2014 -
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Orphan designation: for: Treatment of medullary thyroid carcinoma
Date of first decision: 06/02/2009, Positive, Last updated: 12/05/2014 -
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Orphan designation: for: Treatment of tuberculosis
Date of first decision: 26/08/2005, Positive, Last updated: 01/04/2014