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Direct healthcare professional communication (DHPC): Rubraca (rucaparib): restriction of indication
Active substance: rucaparib camsylate, DHPC type: Referral - Article 20 procedure, Restriction of indication, Last updated: 08/08/2022tube, or primary peritoneal cancer, who have been treated with … advanced, recurrent ovarian cancer (HR = 1.31 [95% CI: 1.00 … tube, or primary peritoneal cancer who are in response (complete … -
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Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Accord
metformin hydrochloride, sitagliptin hydrochloride monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 22/07/2022,
, Revision: 1, Authorised, Last updated: 01/09/2022
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Human medicine European public assessment report (EPAR): Zokinvy
Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022,
, 
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, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Vabysmo
Faricimab, Wet Macular Degeneration; Macular Edema; Diabetes Complications
Date of authorisation: 15/09/2022,, Authorised, Last updated: 13/10/2022
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Human medicine European public assessment report (EPAR): Lupkynis
Voclosporin, Lupus Nephritis
Date of authorisation: 15/09/2022,, Authorised, Last updated: 20/09/2022
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Human medicine European public assessment report (EPAR): Thalidomide Lipomed
Thalidomide, Multiple Myeloma
Date of authorisation: 19/09/2022, Authorised, Last updated: 20/10/2022Lipomed Neoplasms, Plasma Cell Cancer Neoplasms Hemostatic Disorders Cardiovascular … treat multiple myeloma (a cancer of the bone marrow) in combination … marrow) in combination with the cancer medicines melphalan and prednisone … -
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Human medicine European public assessment report (EPAR): Tecvayli
Teclistamab, Multiple Myeloma
Date of authorisation: 23/08/2022,, 
, Authorised, Last updated: 20/10/2022
yli Neoplasms, Plasma Cell Cancer Neoplasms Hemostatic Disorders Cardiovascular … Tecvayli is a cancer medicine used to treat adults … with multiple myeloma (a cancer of the bone marrow). It can … -
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Human medicine European public assessment report (EPAR): Opdualag
nivolumab, Relatlimab, Melanoma
Date of authorisation: 15/09/2022,, Authorised, Last updated: 17/10/2022
Nerve Tissue Neoplasms Cancer Nevi and Melanomas Melanoma … melanoma (a type of skin cancer) that has spread or cannot … from 12 years of age whose cancer cells produce a low level … -
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Human medicine European public assessment report (EPAR): Nulibry
fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors
Date of authorisation: 15/09/2022,, , Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Mounjaro
Tirzepatide, Diabetes Mellitus, Type 2
Date of authorisation: 15/09/2022, Authorised, Last updated: 25/11/2022 -
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Human medicine European public assessment report (EPAR): Lutetium (177Lu) chloride Billev (previously Illuzyce)
lutetium (177Lu) chloride, Radionuclide Imaging
Date of authorisation: 15/09/2022, Revision: 1, Authorised, Last updated: 08/12/2022neuroendocrine tumors and prostate cancer, used together with imaging … carry a risk of developing cancer and hereditary defects. The … neuroendocrine tumors and prostate cancer, used together with imaging … -
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Human medicine European public assessment report (EPAR): Amvuttra (updated)
vutrisiran sodium, Amyloid Neuropathies, Familial
Date of authorisation: 15/09/2022,, , Revision: 1, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 4, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Sunlenca
Lenacapavir sodium, HIV Infections
Date of authorisation: 17/08/2022,, Authorised, Last updated: 25/08/2022
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Human medicine European public assessment report (EPAR): Pepaxti
Melphalan flufenamide hydrochloride, Multiple Myeloma
Date of authorisation: 17/08/2022, Revision: 1, Authorised, Last updated: 19/12/2022with multiple myeloma (a cancer of the bone marrow) when the cancer has not responded to previous … transplantation to when the cancer comes back is at least three … this medicine, is a type of cancer medicine known as an alkylating … -
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Human medicine European public assessment report (EPAR): Zolsketil pegylated liposomal
doxorubicin hydrochloride, liposomal, Ovarian Neoplasms; Sarcoma, Kaposi; Multiple Myeloma
Date of authorisation: 31/05/2022, Authorised, Last updated: 20/06/2022treat the following types of cancer in adults: • breast cancer that has spread to other … disease; • advanced ovarian cancer in women whose previous treatment … including a platinum-based cancer medicine has stopped working … -
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Human medicine European public assessment report (EPAR): Celdoxome pegylated liposomal (updated)
doxorubicin hydrochloride, Breast Neoplasms; Ovarian Neoplasms; Multiple Myeloma; Sarcoma, Kaposi
Date of authorisation: 15/09/2022, Authorised, Last updated: 31/01/2023treat the following types of cancer in adults: metastatic breast cancer in patients at risk of heart … ‘Metastatic’ means the cancer has spread to other parts … disease; advanced ovarian cancer in women whose previous treatment … -
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Human medicine European public assessment report (EPAR): Vyvgart
Efgartigimod alfa, Myasthenia Gravis
Date of authorisation: 10/08/2022,, , Revision: 2, Authorised, Last updated: 22/11/2022
System Nervous System Neoplasms Cancer Neoplasms Paraneoplastic … -
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Human medicine European public assessment report (EPAR): Vegzelma
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 17/08/2022,, 
, Revision: 1, Authorised, Last updated: 26/09/2022
Neoplasms Digestive System Neoplasms Cancer Neoplasms Breast Diseases Skin … Vegzelma is a cancer medicine used to treat adults … with the following types of cancer, in combination with other cancer medicines cancer of the colon (large intestine … -
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Human medicine European public assessment report (EPAR): Scemblix
asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022,, , Revision: 1, Authorised, Last updated: 15/12/2022
Conditions, Signs and Symptoms Cancer Neoplasms Leukemia, Myelogenous … Scemblix is a cancer medicine. It is used to treat … myeloid leukaemia (CML), a cancer of the white blood cells … -
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Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , , Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Camcevi
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Authorised, Last updated: 20/06/2022Diseases Male Urogenital Diseases Cancer Neoplasms Prostatic Neoplas … treatment of advanced prostate cancer that is ‘hormone-dependent’ … hormone-dependent prostate cancer and high-risk localised prostate … -
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Human medicine European public assessment report (EPAR): Sondelbay
teriparatide, Osteoporosis
Date of authorisation: 24/03/2022,, , Authorised, Last updated: 16/06/2022
as Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … Paget’s disease, bone cancer or bone metastases cancer that has spread to the bone … -
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Direct healthcare professional communication (DHPC): Imlygic (talimogene laherparepvec): Special considerations to minimize the potential occurrence of adverse events in HSV-1 seronegative patients receiving vials from affected lots: Injections from Imlygic 106 PFU/mL vials from the affected lot numbers ...
Active substance: talimogene laherparepvec, DHPC type: Adverse event, Quality defect, Last updated: 16/06/2022experienced in the treatment of cancer, pharmacists, hospital pharmacists … -
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Direct healthcare professional communication (DHPC): Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 30/05/2022adult patients with breast cancer, melanoma, or localised squamous …