Selected EMA news
April 2025
New medicines recommended for approval
- Xoanacyl (ferric citrate coordination complex)
Treatment of concomitant hyperphosphatemia and iron deficiency in adults with chronic kidney disease
New information on approved medicines
- Bosulif (bosutinib) - extension of indication and new pharmaceutical form
Treatment of myeloid leukemia (blood cancer) - Calquence (acalabrutinib) - new indication
Treatment of lymphoma and leukemia (blood cancers)
Negative CHMP opinions on extension of indication
- Pemazyre (pemigatinib)
Intended to treat myeloid/lymphoid neoplasms (blood cancers)
March 2025
New medicines recommended for approval
- Lynozyfic (linvoseltamab)
Treatment of refractory multiple myeloma (a cancer of the bone marrow)
New information on approved medicines
- Calquence (acalabrutinib) - new indication
Treatment of blood cancer - Columvi (glofitamab) - new indication
Treatment of blood cancer - Darzalex (daratumumab) - change of indication
Treatment of multiple myeloma (a cancer of the bone marrow) and light chain amyloidosis (a blood disease in which deposits of abnormal proteins, called amyloids, accumulate and cause damage in tissues and organs) - Fabhalta (iptacopan) - new indication
Treatment of complement 3 glomerulopathy (a kidney disease) and paroxysmal nocturnal haemoglobinuria, a disease in which there is an excessive breakdown of blood cells - Jaypirca (pirtobrutinib) - new indication
Treatment of blood cancer
Other EMA news
- In a joint statement, EMA and the Heads of Medicines Agencies (HMA) warn the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.
February 2025
New medicines recommended for approval
- Dyrupeg (pegfilgrastim) – biosimilar
Treatment to shorten the duration of neutropenia and help prevent febrile neutropenia after cytotoxic chemotherapy - Eltrombopag Accord (eltrombopag) – generic
Treatment of primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C
New information on approved medicines
- Breyanzi (lisocabtagene maraleucel) – new indication
Treatment of follicular lymphoma and large B-cell lymphoma (types of blood cancer)
Supply shortages
- Eldisine (vindesine)
Treatment of different types of blood cancers, such as acute lymphoblastic leukemia and chemotherapy-refractory lymphoma, as well as certain solid tumors
January 2025
New medicines recommended for approval
- Rytelo (imetelstat sodium) - orphan
Treatment of anemia (low levels of red blood cells) - Zefylti (filgrastim) – biosimilar
Treatment of neutropenia (low level of white blood cells) in patients having chemotherapy or a bone marrow transplant
New information on approved medicines
- Blincyto (blinatumomab) - extension of indication
Treatment of B-precursor acute lymphoblastic leukemia (a type of blood cancer)
December 2024
New information on approved medicines
- Sarclisa (isatuximab) - new indication
Treatment of multiple myeloma (a type of blood cancer)
Withdrawal of applications for extension of indication
- Inaqovi (cedazuridine / decitabine)
Treatment of different types of blood cancer
Direct Healthcare Professional Communication (DHPC)
- Pegasys (peginterferon alfa-2a)
Treatment of polycythaemia vera (a disease in which the body produces too many red blood cells), essential thrombocythaemia (a disease in which there are too many platelets in the blood), hepatitis B and C
November 2024
New medicines recommended for approval
- Eltrombopag Viatris (eltrombopag) – generic
Treatment of primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C (disease in which patients have low levels of blood platelets) - Alhemo (concizumab)
Prevention of bleeding in patients with hemophilia A or hemophilia B
Supply shortages
- Pegasys (peginterferon alfa-2a)
Treatment of polycythaemia vera (a disease in which the body produces too many red blood cells), essential thrombocythaemia (a disease in which there are too many platelets in the blood), and hepatitis B and C (diseases of the liver due to infection with the hepatitis B and C viruses)
October 2024
New medicines recommended for approval
- Pomalidomide Teva (pomalidomide) – generic
Treatment of multiple myeloma (a type of blood cancer) - Hympavzi (marstacimab) – orphan medicine
Treatment of bleeding episodes
New information on approved medicines
- Darzalex (daratumumab) – new indication – orphan medicine
Treatment of multiple myeloma (a type of blood cancer) - Esperoct (turoctocog alfa pegol) – extension of indication
Treatment and prevention of bleeding
Direct Healthcare Professional Communication (DHPC)
- Oxbryta (voxelotor) - Suspension of EU marketing authorization
Treatment of anaemia in patients with sickle cell disease
September 2024
Safety update
- Withdrawal of Oxbryta (Voxelotor) – marketing authorization suspended
Treatment of haemolytic anaemia (excessive breakdown of red blood cells) due to sickle cell disease
New medicines approved
- Adzynma (rADAMTS13) - orphan medicine
Treatment of congenital thrombotic thrombocytopenic purpura (an inherited clotting disorder)
Other EMA news
- EMA's safety committee, PRAC, has recommended measures to minimize the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole.
August 2024
Safety update
- Review of Oxbryta (Voxelotor) – review started
Treatment of haemolytic anaemia (excessive breakdown of red blood cells) due to sickle cell disease
Direct Healthcare Professional Communication (DHPC)
- Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta (CD19- or BCMA-directed CAR T-cell therapies)
Treatment of types of leukaemia, lymphoma and multiple myeloma (blood cancers) - NovoSeven (eptacog alfa (activated))
Treatment of bleeding episodes and for preventing bleeding after surgical procedures in patients with clotting disorders
July 2024
Positive CHMP opinions on new medicines
- Nilotinib Accord (nilotinib) – generic
Treatment of chronic myelogenous leukaemia (blood cancer) - Ordspono (odronextamab) – orphan medicine
Treatment of different kind of blood cancers - Piasky (crovalimab)
Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells)
New medicines authorized
- Fabhalta (Iptacopan) – orphan medicine
Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells), thrombosis (blood clots in blood vessels), pancytopenia (low levels of blood cells) and dark urine (due to large amounts of haemoglobin being released into the urine)
New information on authorized medicines
- Tepkinly (epcoritamab) – new indication – orphan – conditional approval
Treatment of lymphoma and large B-cell cancer (blood cancers) - Pegasys (peginterferon alfa-2a) – extension of indication
Treatment of polycythaemia vera (blood disease leading to production of too many red blood cells), essential thrombocythaemia (too many platelets in the blood), chronic hepatitis B and C
Safety update
- Review of Metamizole-containing medicinal products – review started
Treatment of pain
Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to minimise it
June 2024
Positive CHMP opinions on new medicines
- Durveqtix (fidanacogene elaparvovec)
Treatment of haemophilia B - Dasatinib Accord Healthcare (dasatinib) – generic of Sprycel
Treatment of chronic myelogenous leukaemia, a type of blood cancer - Pomalidomide Accord (pomalidomide) – generic of Imnovid
Treatment of multiple myeloma, cancer of the bone marrow - Pomalidomide Zentiva (pomalidomide) – generic of Imnovid
Treatment of multiple myeloma, cancer of the bone marrow
Safety update
- CAR T-cell medicines (Yescarta, Tecartus, Carvykti, Abecma, Breyanzi, Kymriah) - PRAC recommendation
Personalized treatment for different types of blood cancer that uses a patient’s own white blood cells (T-cells) to attack the cancer
May 2024
Positive CHMP opinions on new medicines
- Altuvoct (efanesoctocog alfa)
Treatment and prevention of bleeding in patients with hemophilia A
April 2024
Positive CHMP opinions on new medicines
- Fabhalta (iptacopan) – orphan medicine
Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells)
Withdrawal of applications for new medicines
- Adcetris (brentuximab vedotin)
Treatment of certain lymphomas (cancers of lymphocytes, types of white blood cells)
Supply shortages
- Fludarabine
Treatment of chronic lymphocytic leukaemia (type of blood cancer)
March 2024
Positive CHMP opinions on new medicines
- Voydeya (danicopan) – orphan medicine
Add-on therapy to ravulizumab or eculizumab for the treatment of residual haemolytic anaemia in adult patients with paroxysmal nocturnal haemoglobinuria, rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells (haemolytic anaemia) by the immune system
New information on authorized medicines
- Carvykti (ciltacabtagene autoleucel) – orphan medicine – conditional approval – extension of indication
Treatment of relapsed and refractory multiple myeloma (cancer of the bone marrow) - Reblozyl (luspatercept) – extension of indication
Treatment of anaemia (low red blood cell counts) - Xromi (hydroxycarbamide) – extension of indication
Treatment of sickle cell disease
Supply shortages
- Eldisine (vindesine)
Treatment of different types of blood cancers, such as acute lymphoblastic leukaemia and chemotherapy-refractory lymphoma, as well as certain solid tumours
February 2024
Positive CHMP opinions on new medicines
- Ryzneuta (efbemalenograstim alfa)
Treatment to reduce the duration of neutropenia (low level of white blood cells) and the incidence of febrile neutropenia due to chemotherapy
New information on authorized medicines
- Aspaveli (pegcetacoplan) – orphan medicine – extension of indication
Treatment of paroxysmal nocturnal haemoglobinuria (PNH), a condition in which there is excessive breakdown of red blood cells - Abecma (idecabtagene vicleucel) – orphan medicine – conditional approval – extension of indication
Treatment of multiple myeloma (a cancer of the bone marrow)
January 2024
Positive CHMP opinions on new medicines
- Casgevy (exagamglogene autotemcel) – orphan medicine – conditional approval
Treatment of transfusion dependent β-thalassemia and sickle cell disease - Pomalidomide Viatris (pomalidomide) – generic of Imnovid
Treatment of multiple myeloma
New information on authorized medicines
- VeraSeal (human fibrinogen / human thrombin) – extension of indication
Treatment for stopping bleeding during surgeries
Negative CHMP opinions on renewal of authorized medicine
- Blenrep (belantamab mafodotin)
Intended for treatment of multiple myeloma
November–December 2023
Positive CHMP opinions on new medicines
- Elrexfio (elranatamab) – conditional approval
Treatment of multiple myeloma
New medicines authorized
- Enrylaze (crisantaspase)
Treatment of lymphoblastic leukaemia and lymphoblastic lymphoma - Inaqovi (cedazuridine / decitabine)
Treatment of myeloid leukaemia - Tepkinly (epcoritamab) – orphan medicine – conditional approval
Treatment of blood cancer called diffuse large B-cell lymphoma - Vanflyta (quizartinib)
Treatment of myeloid leukaemia
New information on authorized medicines
- Veyvondi (vonicog alfa) – orphan medicine – extension of indication
Treatment of von Willebrand disease
Special update, November 2023
Electronic Product Information (ePI) for selected human medicines published for first time
EMA, along with the Heads of Medicines Agencies (HMA) and the European Commission (EC) have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union.
This forms part of the ePI initiative, a one-year pilot by HMA, EMA, and the EC to enable the transition to an electronic system for medicines evaluated both nationally and at European level.
- More information about the ePI initiative.
- The published ePIs can be viewed at the Product Lifecycle Management Portal.
October 2023
Positive CHMP opinions on new medicines
- Vanflyta (quizartinib) – orphan medicine
Treatment of acute myeloid leukaemia (blood cancer)
- Elrexfio (elranatamab) – orphan medicine – conditional approval
Treatment of multiple myeloma (a type of white blood cell cancer)
New medicines authorized
- Talvey (talquetamab) – orphan medicine – conditional approval
Treatment of multiple myeloma (a type of white blood cell cancer)
New information on authorized medicines
- Adcetris (brentuximab vedotin) – orphan medicine – extension of indication
Treatment of stage III Hodgkin lymphoma (a cancer of lymphocytes)
Withdrawal of authorized medicines
Withdrawal of applications for extension of indication
- Iclusig (ponatinib)
Intended for the treatment of adults newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukaemia (blood cancer)
Negative CHMP opinions on renewal of conditional marketing authorization
- EMA recommends non-renewal of authorization of multiple myeloma medicine Blenrep (belantamab mafodotin)
September 2023
Direct Healthcare Professional Communication (DHPC)
- Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)
Treatment of various conditions
August 2023
Positive CHMP opinions on new medicines
- Enrylaze (crisantaspase)
Treatment of acute lymphoblastic leukaemia (a type of blood cancer)
- Inaqovi (cedazuridine / decitabine) – orphan medicine
Treatment of myeloid leukaemia (a type of blood cancer)
- Talvey (talquetamab) – orphan medicine – conditional approval
Treatment of multiple myeloma, a type of white blood cell cancer
- Tepkinly (epcoritamab) – conditional approval
Treatment of large B-cell lymphoma (a type of blood cancer)
New medicines authorized
- Columvi (glofitamab) – orphan medicine
Treatment of blood cancer called diffuse large B-cell lymphoma (a type of blood cancer)
Withdrawal of applications for extension of indication
- Gazyvaro (obinutuzumab)
Intended to prevent a serious side effect (cytokine release syndrome) that occurs with the blood cancer medicine Columvi
Withdrawal of applications for new medicines
- Jesduvroq (daprodustat)
Treatment of symptomatic anaemia in patients with chronic kidney disease
Direct Healthcare Professional Communication (DHPC)
- Replacement BAXJECT II / BAXJECT II Hi-Flow Reconstitution Devices co-packaged with Advate/Feiba/Rixubis
Treatment of hemophilia
July 2023
Positive CHMP opinions on new medicines
- Jesduvroq (daprodustat)
Treatment of anaemia in adults with chronic kidney disease
New information on authorized medicines
- Mircera (methoxy polyethylene glycol-epoetin beta) - extension of indication
Treatment of anaemia associated with chronic kidney disease in children
- Refixia (nonacog beta pegol) - extension of indication
Treatment of haemophilia B
Withdrawal of applications for new medicines
- Dyrupeg (pegfilgrastim)
Intended to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cells in cancer patients)
- Zefylti (filgrastim)
Intended to stimulate the production of white blood cells
Direct Healthcare Professional Communication (DHPC)
- Adakveo (crizanlizumab) - orphan medicine
Prevention of painful crises in patients with sickle cell disease
June 2023
New medicines authorized
- Epysqli (Eculizumab)
Treatment of paroxysmal nocturnal haemoglobinuria, a disease in which excessive breakdown of red blood cells results in various medical complications
- Tibsovo (ivosidenib)
Treatment of acute myeloid leukaemia (a blood cancer) and biliary tract cancer (cancer of the bile ducts)
- Vafseo (vadadustat)
Treatment of anaemia (low levels of red blood cells) associated with chronic kidney disease
Supply shortages
- Actilyse (alteplase)
Treatment of acute pulmonary embolism (blood clot in blood vessels supplying the lung)
Safety update
- Review of Adakveo (crizanlizumab) - CHMP Opinion
Prevention of painful crises in patients with sickle cell disease
May 2023
New information on authorized medicines
- Adempas (riociguat) – New indication
Treatment of high blood pressure in lungs in children
Safety update
- Review of Adakveo (crizanlizumab) – review started
Treatment of painful crises in patients with sickle cell disease
April 2023
Positive CHMP opinions on new medicines
- Epysqli (eculizumab) – Biosimilar
Treatment of paroxysmal nocturnal heamoglobinuria
New information on authorized medicines
- Ultomiris (ravulizumab) – New indication and new pharmaceutical form
Treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
Withdrawal of applications for new medicines
- Feraheme (ferumoxytol)
Intended for treatment of iron deficiency anaemia
Safety update
- Review of Pseudoephedrine-containing medicinal products (pseudoephedrine) – review started
Treatment of nasal congestion
Direct Healthcare Professional Communication (DHPC)
- Janus kinase inhibitors (JAKi) (abrocitinib, filgotinib, baricitinib, upadacitinib, tofacitinib) Updated recommendations to minimize risk of cancer, heart problems and blood clots
March 2023
Positive CHMP opinions on new medicines
- Bekemv (eculizumab) – Biosimilar medicine
Treatment of paroxysmal nocturnal haemoglobinuria
- Tibsovo (ivosidenib) - Orphan medicine
Treatment of myeloid leukaemia
- Tidhesco (ivosidenib) - Orphan medicine
Treatment of myeloid leukaemia
- Vafseo (vadadustat) Treatment of anaemia associated with chronic kidney disease
New medicines authorized
- Plerixafor Accord (plerixafor) - generic of Mozobil
Medicine used in cancer patients to obtain cells from the bone marrow for use in transplantation
Direct Healthcare Professional Communication (DHPC)
- Adakveo (crizanlizumab)
Treatment of anaemia
- Neofordex (dexamethasone)
Treatment of multiple myeloma
February 2023
New information on authorized medicines
- Reblozyl (luspatercept) – Extension of indication – Orphan medicine
New indication: Treatment of anemia in patients with beta-thalassaemia
Safety update
- Review of Adakveo (crizanlizumab) - Review started (Scope of safety referral)
- Prevention of painful crises in patients with sickle cell disease
January 2023
Positive CHMP opinions on new medicines
- Hemgenix (etranacogene dezaparvovec) – Orphan Medicine, conditional approval
Treatment of severe and moderately severe hemophilia B
New medicines authorized
- Pyrukynd (mitapivat) – Orphan medicine
Treatment of adults with pyruvate kinase deficiency
New information on authorized medicines
- Hemlibra (emicizumab) – Extension of indication
New indication: routine prophylaxis of bleeding episodes in patients with hemophilia A without factor VIII inhibitors who have moderate disease with severe bleeding phenotype
November 2022
Positive CHMP opinions on new medicines
- Ebvallo (tabelecleucel) – Orphan Medicine, Exceptional circumstances
Treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
- Plerixafor Accord (plerixafor) – Generic of Mozobil
Treatment of blood cancer after bone marrow transplantation
New medicines authorized
- Thalidomide Lipomed (thalidomide) – Biosimilar
Treatment of multiple myeloma
New information on authorized medicines
- Brukinsa (zanubrutinib) – Orphan Medicine
Treatment of chronic lymphocytic leukemia
September 2022
Positive CHMP opinions on new medicines
- Enjaymo (sutimlimab) – Orphan Medicine
Treatment of hemolytic anaemia - Pyrukynd (mitapivat) – Orphan Medicine
Treatment of pyruvate kinase deficiency - Zynlonta (loncastuximab tesirine) – Orphan Medicine
Treatment of diffuse large B-cell lymphoma and high-grade B-cell lymphoma
August 2022
New information on authorized medicines
- Tecartus (Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured) – Orphan medicine, Conditional Approval
New indication: Treatment of mantle cell lymphoma
Withdrawal of applications for new medicines
- Parsaclisib Incyte Biosciences Distribution B.V. (parsaclisib)
Intended for the treatment of marginal zone lymphoma
July 2022
New information on new medicines
- Tecvayli (teclistamab) - recommended for conditional marketing authorization
Treatment of relapsed and refractory multiple myeloma
Positive CHMP opinions on new medicines
- Pepaxti (melphalan flufenamide) – Orphan Medicine
Treatment of multiple myeloma - Roctavian (valoctocogene roxaparvovec) – Orphan Medicine – Conditional approval
Treatment of haemophilia - Scemblix (asciminib) – Orphan Medicine
Treatment of Philadelphia chromosome positive chronic myeloid leukaemia
New medicine authorized
- Lunsumio (mosunetuzumab) – Orphan Medicine – Conditional approval
Treatment of follicular lymphoma
New information on authorized medicines
- Imbruvica (ibrutinib) - Extension of indication
Treatment of chronic lymphocytic leukaemia
June 2022
Positive CHMP opinions on new medicines
- Cevenfacta (Eptacog beta (activated))
Treatment of bleeding episodes
New medicines authorized
- Breyanzi (lisocabtagene maraleucel)
Treatment of different types of blood cancers
Withdrawal of applications for new medicines
- HemAryo (eptacog alfa (activated))
Intended for treating bleeding episodes and for preventing bleeding after surgical procedures in patients with clotting disorders
April 2022
Positive CHMP opinions on new medicines
- Carvykti (ciltacabtagene autoleucel) – Conditional approval
Treatment of multiple myeloma
- Zolsketil pegylated liposomal (doxorubicin)
Treatment of breast and ovarian cancers, multiple myeloma and AIDS-related Kaposi's sarcoma
New medicines authorized
- Dasatinib Accord and Dasatinib Accordpharma (dasatinib) - Generic of Sprycel
Treatment of leukemia - Oxbryta (Voxelotor) – Orphan medicine
Treatment of haemolytic anaemia in patients with sickle cell disease
New information on authorized medicines
- Kymriah (tisagenlecleucel) – Orphan medicine
New indication: Treatment of follicular lymphoma
- Polivy (polatuzumab vedotin) – Orphan medicine
New indication Treatment of large B-cell lymphoma
Withdrawal of applications for extension of indication
- Vyxeos liposomal (daunorubicin / cytarabine) – Orphan medicine
Intended for the treatment of patients aged 1 to 21 years with acute myeloid leukaemia
March 2022
Positive CHMP opinions on new medicines
-
Carvykti (ciltacabtagene autoleucel)
Treatment of adult patients with relapsed and refractory multiple myeloma
New medicines authorized
- Evrenzo (roxadustat)
Treatment of the symptoms of anaemia caused by chronic kidney failure - Rivaroxaban Mylan (rivaroxaban) - generic of Xarelto
Treatment that prevents blood clotting
February 2022
Positive CHMP opinions on new medicines
- Breyanzi (lisocabtagene maraleucel) – Orphan medicine
Treatment of lymphoma - Dasatinib Accord (dasatinib) – Generic of Sprycel
Treatment of leukemia - Dasatinib Accordpharma (dasatinib) – Generic of Sprycel
Treatment of leukemia - Stimufend (pegfilgrastim) – Biosimilar of Neulasta
Treatment of neutropenia after chemotherapy
New information on authorized medicines
- Ayvakyt (avapritinib) – Orphan medicine
New indication Treatment of gastrointestinal stromal tumour and systemic mastocytosis
Withdrawal of applications for new medicines
- Aliqopa (copanlisib)Treatment of previously treated marginal zone lymphoma
January 2022
Positive CHMP opinions on new medicines
- Oxbryta (Voxelotor) - Orphan Medicine
Treatment of anemia due to sickle cell disease
New medicines authorized
- Aspaveli (pegcetacoplan) - Orphan Medicine
Treatment of paroxysmal nocturnal haemoglobinuria
December 2021
Positive CHMP opinions on new medicines
- Tavneos (avacopan) - Orphan Medicine
Treatment of granulomatosis with polyangiitis or microscopic polyangiitis
November 2021
Positive CHMP opinions on new medicines
- Aspaveli (pegcetacoplan)
Treatment of paroxysmal nocturnal haemoglobinuria
New medicines authorized
- Imatinib Koanaa (imatinib) generic of Glivec
Treatment of blood cancers and gastrointestinal stromal tumors
New information on authorized medicines
- Hizentra (human normal immunoglobulin (SCIg) - Extension of indication
Treatment of immunologic deficiency syndromes
October 2021
Positive CHMP opinions on new medicines
- Brukinsa (zanubrutinib) - Orphan medicine
Treatment of Waldenström’s macroglobulinaemia
September 2021
New medicine authorized
- Evrenzo (roxadustat)
Treatment of anaemia symptoms (low red blood cell counts) caused by chronic kidney failure
August 2021
Positive CHMP opinions on new medicines
- Imatinib Koanaa (imatinib)
Treatment of leukaemia and gastrointestinal stromal tumours
New information on authorized medicines
- Ultomiris (ravulizumab) - extension of indication
Treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome
Negative CHMP opinions on extension of indication
- Siklos (hydroxycarbamide)
Intended to extend the use of Siklos to include the treatment of severe chronic (long-term)
anaemia in patients suffering from sickle cell syndrome
Safety update
- Review of Zynteglo (betibeglogene autotemcel) - CHMP Opinion
Treatment of beta thalassaemia
July 2021
Positive CHMP opinions on new medicines
- Evrenzo (roxadustat)
Treatment of anaemia symptoms in patients with chronic kidney disease
New medicines authorized
- Inrebic (fedratinib) Orphan Medicine
Treatment of myelofibrosis
- Onureg (azacitidine)
Treatment of acute myeloid leukaemia
April 2021
Positive CHMP opinions on new medicines
- Copiktra (duvelisib)
Treatment of relapsed or refractory chronic lymphocytic leukaemia and refractory follicular lymphoma
New medicines authorized
- Inrebic (fedratinib) – Orphan Medicine
Treatment of myelofibrosis
Negative CHMP opinions on new medicines
- Gamifant (emapalumab)
Intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH)
Withdrawal of applications to change the marketing authorization
- Brilique (ticagrelor)
Intended to be used with aspirin to prevent problems caused by blood clots
Safety update
- Review of Zynteglo (betibeglogene autotemcel) - review started (Art. 20)
Treatment of a blood disorder known as beta thalassaemia
March 2021
Positive CHMP opinions on new medicines
- Nexpovio (selinexor)
Treatment of multiple myeloma (cancer of the bone marrow) - Thiotepa Riemser (thiotepa) generic of Tepadina
Treatment prior to blood-stem cell transplantation
New medicines authorized
- Lenalidomide KrKa (lenalidomide) generic of Revlimid
Treatment of multiple myeloma and follicular lymphoma (blood cancers) - Lenalidomide KrKa d.d. (lenalidomide) generic of Revlimid
Treatment of multiple myeloma, myelodysplastic syndromes, and follicular lymphoma (blood cancers) - Lenalidomide KrKa d.d. Novo mesto (lenalidomide) generic of Revlimid
Treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma (blood cancers)
New information on authorized medicines
- Sarclisa (isatuximab) - extension of indication
Treatment of multiple myeloma (blood cancer)
Withdrawal of authorized medicines
- Udenyca (pegfilgrastim)
Treatment of neutropenia (low level of white blood cells)
Other information
- Precautionary marketing suspension of thalassaemia medicine Zynteglo (betibeglogene autotemcel)
Direct Healthcare Professional Communication (DHPC)
- Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
February 2021
New medicines authorized
- Elzonris (tagraxofusp) Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN)
- Tecartus (Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured) Treatment of mantle cell lymphoma – Orphan Medicine
January 2021
Positive CHMP opinions on new medicines
- Inrebic (fedratinib) – Orphan Medicine
Treatment of of primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia - Lenalidomide KrKa (lenalidomide) - generic of Revlimid
Treatment of multiple myeloma and follicular lymphoma - Lenalidomide KrKa d.d. (lenalidomide) - generic of Revlimid
Treatment of multiple myeloma, myelodysplastic syndromes and follicular lymphoma - Lenalidomide KrKa d.d. Novo mesto (lenalidomide) - generic of Revlimid
Treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma - Lumoxiti (moxetumomab pasudotox)
Treatment of relapsed or refractory hairy cell leukaemia – Orphan Medicine, Exceptional Circumstances
New information on authorized medicines
- Nplate (romiplostim) - extension of indication
Treatment of patients with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient’s immune system destroys platelets
New information on authorized medicines
- Doptelet (avatrombopag) - new indication Treatment of severe thrombocytopenia in patients with chronic liver disease
December 2020
Positive CHMP opinions on new medicines-following re-examination
- Elzonris (tagraxofusp) Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) – Exceptional Circumstances
New medicines authorized
- Adakveo (crizanlizumab) Prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
- Calquence (acalabrutinib) Treatment of chronic lymphocytic leukaemia – Orphan medicine
- Nyvepria (pegfilgrastim) Treatment of neutropenia in cancer patients - Biosimilar of Neulasta
- Phelinun (melphalan ) Treatment of blood and bone marrow cancers and preparing patients for blood stem cell transplants
- Rivaroxaban Accord (rivaroxaban) Treatment and prevention of blood clots - Generic
New information on authorized medicines
- Kyprolis (carfilzomib) - extension of indication Treatment of adult patients with multiple myeloma
Safety update
- Direct healthcare professional communication: Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization
November 2020
Positive CHMP opinions on new medicines
- Lenalidomide Mylan (lenalidomide) - Generic
Treatment of multiple myeloma and follicular lymphoma (blood cancers)
New medicines authorized
- Arsenic trioxide medac (arsenic trioxide) - Generic
Treatment of acute promyelocytic leukaemia (blood cancer)
New information on authorized medicines
- Blincyto (blinatumomab) - extension of indication – Orphan medicine
Treatment of B-precursor acute lymphoblastic leukaemia (a type of blood cancer)
Safety update
- Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
October 2020
Positive CHMP opinions on new medicines
- Nyvepria (pegfilgrastim) - Biosimilar of Neulasta
Treatment of neutropenia in cancer patients - Rivaroxaban Accord (rivaroxaban) - Generic
Treatment and prevention of blood clots
New medicines authorized
- Blenrep (belantamab mafodotin) – Conditional Approval – Orphan Medicine
Treatment of multiple myeloma
Re-examination request following negative CHMP opinions on new medicines
- Elzonris (tagraxofusp)
Intended for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive type of blood cancer
August 2020
Positive CHMP opinions on new medicines
- Adakveo (crizanlizumab)
Prevention of recurrent vaso-occlusive crises in patients with sickle cell disease - Arsenic trioxide medac (arsenic trioxide)
Treatment of acute promyelocytic leukaemia - Calquence (acalabrutinib) – Orphan Medicine
Treatment of chronic lymphocytic leukaemia
New medicines authorized
- Daurismo (glasdegib)
Treatment of acute myeloid leukaemia (blood cancer) - Reblozyl (luspatercept) – Orphan Medicine
Treatment of anaemia caused by myelodysplastic syndromes (MDS) or betathalassaemia
New information on authorized medicines
- Crysvita (burosumab) - change and extension of indication – Orphan Medicine – Conditional Approval
Treatment of X-linked hypophosphataemia - Imbruvica (ibrutinib) - extension of indication – Orphan Medicine
Treatment of blood cancers - NovoThirteen (catridecacog)- extension of indication
Prevention of bleeding in patients with inherited blood clotting disorder
Negative CHMP opinions on new medicines
- Gamifant (emapalumab)
Intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH)
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