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Summary of opinion: Ertapenem SUN
ertapenem, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Vyvgart
efgartigimod alfa, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Scemblix
asciminib, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Crysvita
burosumab, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Roctavian
Valoctocogene roxaparvovec, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Imcivree (new)
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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Summary of opinion: Tecartus (new)
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, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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Summary of opinion: Pepaxti
melphalan flufenamide, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet
Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020 -
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Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020 -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020 -
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Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)
Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022 -
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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone) 100 micrograms/dose powder and solvent for solution for injection: expected shortage from June 30th, 2022
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 29/04/2022 -
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Direct healthcare professional communication (DHPC): Ocaliva (obeticholic acid): New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of prior hepatic decompensation
Active substance: Obeticholic acid, DHPC type: New contraindication, Last updated: 09/06/2022 -
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin) 140 mg powder for concentrate for solution for injection: Important information on plastic vial flip-off cap colour
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
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Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy
Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021 -
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Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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Direct healthcare professional communication (DHPC): Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis
Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, DHPC type: Adverse event, Last updated: 22/03/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001143-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet, Capsule, hard
Decision date: 19/07/2021, Last updated: 25/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001864-PIP01-15-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 08/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib (tosilate monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002268-PIP02-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age appropriate oral liquid formulation
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001207-PIP01-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000142-PIP02-09-M11, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Powder and gel for gel
Decision date: 10/05/2021, Last updated: 16/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000115-PIP01-07-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 10/05/2021, Last updated: 16/02/2022, Compliance check: X