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216 results
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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): 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): 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): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage
Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 19/10/2022 -
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Direct healthcare professional communication (DHPC): Supply Constraint of Sarilumab [Kevzara®]
Active substance: sarilumab, DHPC type: Medicine shortage, Last updated: 09/11/2021 -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021 -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021 -
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Direct healthcare professional communication (DHPC): Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with thrombocytopenia - Updated information
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Type II variation, Last updated: 02/06/2021 -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): contraindication in individuals with previous capillary leak syndrome
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 23/06/2021 -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/10/2021 -
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Direct healthcare professional communication (DHPC): Systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence
Active substance: Delafloxacin, levofloxacin, DHPC type: Safety signal, Last updated: 29/10/2020 -
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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: 08/08/2022 -
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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): 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): COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 26/04/2021 -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 19/07/2021 -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE)
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 13/10/2021 -
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Direct healthcare professional communication (DHPC): Venclyxto - (venetoclax) film coated tablets: Updated recommendations on tumour lysis syndrome (TLS) in CLL patients
Active substance: Venetoclax, DHPC type: Type II variation, Last updated: 10/06/2021 -
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Direct healthcare professional communication (DHPC): Beovu ® (brolucizumab): Updated recommendations to minimise the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion
Active substance: Brolucizumab, DHPC type: Type II variation, Last updated: 05/11/2021 -
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Direct healthcare professional communication (DHPC): COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk of myocarditis and pericarditis
Active substance: Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), DHPC type: Safety signal, Last updated: 19/07/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Trogarzo, Ibalizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002311-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 16/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Retsevmo, Selpercatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002544-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form
Decision date: 30/09/2021, Last updated: 13/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Rozlytrek, Entrectinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002096-PIP01-16-M03, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Coated granules
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veltassa, Patiromer calcium (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001720-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 30/09/2021, Last updated: 12/01/2023, Compliance check: X