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Referral: Ranitidine-containing medicinal products
ranitidine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/09/2020, EC decision date: 24/11/2020, Last updated: 17/02/2021substance that could cause cancer) based on animal studies … ranitidine increases the risk of cancer, and any possible risk is … ranitidine increases the risk of cancer. However, NDMA has been found … -
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Referral: Ulipristal acetate 5mg medicinal products
ulipristal acetate, associated names: Esmya, Ulipristal Acetate Gedeon Richter, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 11/01/2021, Last updated: 03/02/2021in the womb that are not cancerous) only if: you have not reached … in the womb that are not cancerous) only if: − you have not … of uterine fibroids (non-cancerous tumours of the womb) in women … -
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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: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020dehydrogenase (DPD) before starting cancer treatment with fluorouracil … doctor may consider starting cancer treatment at lower doses … -
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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: Paclitaxel Hetero and associated names
paclitaxel, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/10/2018, EC decision date: 11/01/2019, Last updated: 21/01/2019for the treatment of breast cancer, cancer of the ovaries, non-small … ovaries, non-small cell lung cancer and Kaposi’s sarcoma (a cancer of the blood vessels) in … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021ensure that the excess risk of cancer from nitrosamines in any … substances that could cause cancer). In the vast majority of sartan … does not exceed a lifetime cancer risk (lifelong exposure … -
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Referral: Methotrexate containing medicinal products
methotrexate, associated names: Nordimet, Jylamvo, Ledertrexate, Maxtrex, Metex, Metoject, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/08/2019, EC decision date: 21/10/2019, Last updated: 31/10/2019whereas for some types of cancer, the dose is higher and the … medicines are used to treat cancers such as acute lymphoblastic … -
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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: Hydroxyethyl starch (HES) containing medicinal products
hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/10/2017, EC decision date: 17/07/2018, Last updated: 27/07/2018 -
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Referral: Cardioxane
dexrazoxane, Article 13 referrals
Status: European Commission final decision, opinion/position date: 19/07/2017, EC decision date: 19/07/2017, Last updated: 26/07/2017high cumulative doses of cancer medicines called anthracyclines … used in adults with breast cancer to prevent long-term harmful … treatment with the anthracycline cancer medicines doxorubicin and … -
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Referral: Etopophos
etoposide phosphate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2017, EC decision date: 26/06/2017, Last updated: 14/07/2017Etopophos? Etopophos is a cancer medicine used to treat: testicular … used to treat: testicular cancer, lung cancer, ovarian cancer, gestational trophoblastic … Etopophos? Etopophos is a cancer medicine used to treat: testicular … -
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Referral: Vepesid
etoposide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2017, EC decision date: 26/06/2017, Last updated: 14/07/2017is Vepesid? Vepesid is a cancer medicine used to treat: testicular … used to treat: testicular cancer, lung cancer, ovarian cancer and … is Vepesid? Vepesid is a cancer medicine used to treat: testicular … -
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Referral: Valproate and related substances
sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide, associated names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2018, EC decision date: 31/05/2018, Last updated: 07/06/2018 -
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Referral: Haldol and associated names
haloperidol, associated names: Aloperidin, Haldol-Janssen, Serenase, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 28/04/2017, Last updated: 05/05/2017 -
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Referral: Haldol Decanoate and associated names
haloperidol decanoate, associated names: Haldol Decanoat, Haldol Decanoas, Serenase Dekanoat, Serenase Depot, Haldol - Janssen Decanoat Depot, Haldol Decanoato, Haldol Depot, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 28/04/2017, Last updated: 11/05/2017 -
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Referral: Saroten and associated names
amitriptyline, associated names: Saroten Retard, Redomex, Redomex Diffucaps, Saroten Tabs, Saroten retard Tabs, Saroten 2ml, Sarotex, Sarotex Retard, Sarotex Retard 25, Sarotex Retard 50, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 08/05/2017, Last updated: 06/06/2017 -
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Referral: Lovenox and associated names
enoxaparin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 09/03/2017, Last updated: 22/03/2017 -
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Referral: Durogesic and associated names
fentanyl, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 19/10/2016not the pain is caused by cancer. Durogesic can also be used … not the pain is caused by cancer. Durogesic can also be used … -
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Referral: Paracetamol modified-release
paracetamol, associated names: Alvedon, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2017, EC decision date: 19/02/2018, Last updated: 01/03/2018 -
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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: 02/07/2018to treat certain forms of cancer. The review confirmed that … conditions, and certain types of cancer. Retinoids applied to the … Kaposi's sarcoma (a type of skin cancer). Bexarotene has been authorised … -
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Referral: Novantrone and associated names
mitoxantrone, associated names: Elsep, Ralenova, Article 30 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 24/06/2016, Last updated: 05/07/2016used in the treatment of cancers including breast cancer, non-Hodgkin's lymphoma (a cancer of the lymphatic system … used in the treatment of cancers including breast cancer, non-Hodgkin’s lymphoma (a cancer of the lymphatic system … -
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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