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210 results
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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): 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): Evenity, Romosozumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001075-PIP04-15-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension 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): 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: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): MenQuadfi, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001930-PIP01-16-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 29/07/2021, Last updated: 18/07/2022, 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): Alpivab, Peramivir (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001856-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
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): Vaborem, meropenem trihydrate, vaborbactam (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001731-PIP01-14-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 18/07/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001501-PIP04-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 10/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001045-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 06/05/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-002077-PIP01-16-M04, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 17/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-002018-PIP02-16-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet for oral suspension
Decision date: 09/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-001943-PIP01-16-M06, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 17/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP03-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
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): 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): Zynquista, Sotagliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001517-PIP02-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Film-coated tablet
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): Sarclisa, Isatuximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002205-PIP01-17-M02, 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): Byfavo, Remimazolam (as besilate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Anaesthesiology
PIP number: EMEA-001880-PIP02-19-M02, Route(s) of administration: Intravenous use, Buccal use, Pharmaceutical form(s): Powder for solution for injection or infusion, Orodispersible film, Age-appropriate 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): Juluca, rilpivirine, dolutegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001750-PIP01-15-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X