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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)
Active substance: tocilizumab, Emicizumab, trastuzumab, trastuzumab emtansine, rituximab, pertuzumab, trastuzumab, atezolizumab, DHPC type: Quality defect, Last updated: 17/08/2023 -
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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone): Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 04/10/2022 -
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Direct healthcare professional communication (DHPC): Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
Active substance: Lomitapide, DHPC type: Post-authorisation measure, Last updated: 17/02/2021 -
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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): 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): 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): 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): Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan
Active substance: Metreleptin, DHPC type: Medicine shortage, Last updated: 14/03/2023 -
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Direct healthcare professional communication (DHPC): ADAKVEO (crizanlizumab): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo
Active substance: Crizanlizumab, DHPC type: Referral - Article 20 procedure, Last updated: 14/02/2023 -
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Direct healthcare professional communication (DHPC): ADAKVEO (crizanlizumab): revocation of EU marketing authorisation due to lack of therapeutic efficacy
Active substance: Crizanlizumab, DHPC type: Lack of effect, Referral - Article 20 procedure, Last updated: 15/06/2023 -
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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): ZOLGENSMA (onasemnogene abeparvovec) - Fatal cases of acute liver failure
Active substance: Onasemnogene abeparvovec, DHPC type: Adverse event, Last updated: 17/02/2023 -
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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): 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): Lojuxta, Lomitapide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001124-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, Inotuzumab ozogamicin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001429-PIP01-13-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 19/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evkeeza, Evinacumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002298-PIP01-17-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/09/2022, Last updated: 18/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Lenvatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP02-12-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/08/2022, Last updated: 13/09/2023, Compliance check: X -
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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-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet, Capsule, hard
Decision date: 11/08/2022, Last updated: 13/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001207-PIP02-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/08/2022, Last updated: 13/09/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Hepcludex, Bulevirtide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002399-PIP01-18-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 10/08/2022, Last updated: 31/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dovprela (previously Pretomanid FGK), Pretomanid (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002115-PIP01-17-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Tablet
Decision date: 11/08/2022, Last updated: 30/08/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imcivree, Setmelanotide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: EMEA-002209-PIP01-17-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/08/2022, Last updated: 28/08/2023, Compliance check: X