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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: Procedure started, Last updated: 12/03/2021acute myeloid leukaemia, a cancer of the blood, in a patient … treatment could cause a blood cancer (insertional oncogenesis … to understand whether the cancer might be related to their … -
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Referral: Picato
ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 06/07/2020, Last updated: 16/11/2020increase the risk of skin cancer and that its risks outweigh … patients) developed skin cancer, particularly squamous cell … increase the risk of skin cancer. A study showed that patients … -
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Referral: Xeljanz
tofacitinib, associated names: Xeljanz, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 31/01/2020, Last updated: 06/03/2020attack or have heart failure, cancer, inherited blood clotting … attack or have heart failure, cancer, inherited blood clotting … -
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Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019marketing authorisation for cancer medicine Lartruvo … -
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Referral: Esmya
ulipristal acetate, associated names: Esmya, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/05/2018, EC decision date: 26/07/2018, Last updated: 08/08/2018fibroids, which are benign (non-cancerous) tumours of the womb, in … fibroids, which are benign (non-cancerous) tumours of the womb, in … -
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Referral: Xofigo
radium Ra223 dichloride, associated names: Xofigo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 26/07/2018, EC decision date: 28/09/2018, Last updated: 11/10/2018EMA restricts use of prostate cancer medicine Xofigo … EMA/176752/2018 Prostate cancer medicine Xofigo must not … the use of the prostate cancer medicine Xofigo (radium-223 … -
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Referral: SGLT2 inhibitors (previously canagliflozin)
canagliflozin, empagliflozin, dapagliflozin, metformin, associated names: Xigduo, Ebymect, Edistride, Synjardy, Forxiga, Jardiance, Vokanamet, Invokana, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 04/05/2017, Last updated: 08/05/2017 -
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Referral: Zydelig
idelalisib, associated names: Zydelig, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 15/09/2016, Last updated: 03/10/2016the treatment of the blood cancers chronic lymphocytic leukaemia … clinical studies with the cancer medicine Zydelig. Some changes … patients had finished their cancer treatment, you will have … -
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir, dasabuvir, sofosbuvir, ledipasvir, simeprevir, ombitasvir, paritaprevir, ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017needed to assess risk of liver cancer with these medicines … needed to assess risk of liver cancer with these medicines On … previously been treated for liver cancer could be at risk of their cancer returning early. The CHMP … -
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Referral: Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard
bivalent HPV vaccine (types 16, 18), quadrivalent HPV vaccine (types 6, 11, 16, 18), 9-valent HPV vaccine (types 6, 11, 16, 18, 31, 33, 45, 52 and 58), associated names: Cervarix, Gardasil, Gardasil 9, Silgard, Article 20 procedures
Status: European Commission final decision, opinion/position date: 19/11/2015, EC decision date: 12/01/2016, Last updated: 20/01/2016protect them from cervical cancer and other HPV-related cancers and pre cancerous conditions. In line with … protect them from cervical cancer and other HPV-related cancers and pre cancerous conditions. In line with … -
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Referral: SGLT2 inhibitors
canagliflozin, dapagliflozin, empagliflozin, associated names: Edistride, Ebymect, Xigduo, Vokanamet, Synjardy, Jardiance, Invokana, Forxiga, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 28/04/2016, Last updated: 18/05/2016 -
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Referral: Tysabri
natalizumab, associated names: Tysabri, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 25/04/2016, Last updated: 12/05/2016 -
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Referral: Iclusig
ponatinib, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 15/01/2015, Last updated: 02/03/2015the treatment of leukaemia (cancer of the white blood cells … treatment of leukaemia, a type of cancer that affects white blood … following types of leukaemia (cancer of the white blood cells …