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173 results
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Summary of opinion: Sovaldi
sofosbuvir, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Epclusa
sofosbuvir / velpatasvir, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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Summary of opinion: Zavicefta
ceftazidime / avibactam, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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Summary of opinion: Crysvita
burosumab, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: HyQvia
human normal immunoglobulin, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: Imfinzi
durvalumab, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: Shingrix
herpes zoster vaccine (recombinant, adjuvanted), opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc] (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002068-PIP01-16-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, 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-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zinplava, bezlotoxumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001645-PIP01-14-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 20/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Truberzi, eluxadoline (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001579-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, sodium zirconium cyclosilicate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001539-PIP01-13-M04, Route(s) of administration: Oral use, Nasogastric use, Pharmaceutical form(s): Oral powder
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000914-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001050-PIP01-10-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001822-PIP01-15-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 06/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy, Tenofovir alafenamide (as fumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001584-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Age-appropriate dosage form, other
Decision date: 20/02/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dengvaxia, Live, attenuated, chimeric dengue virus, serotype 1, Live, attenuated, chimeric dengue virus, serotype 2, live, attenuated, chimeric dengue virus, serotype 3, Live, attenuated, chimeric dengue virus, serotype 4
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001545-PIP01-13-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for suspension for injection
Decision date: 21/02/2020, Last updated: 12/06/2020, 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: Pneumology-allergology
PIP number: EMEA-001501-PIP02-13-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001429-PIP01-13-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 10/02/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Lenvatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001119-PIP02-12-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/01/2020, Last updated: 11/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Idelvion, albutrepenonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001107-PIP01-10-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion, Powder and solvent for solution for injection
Decision date: 29/01/2020, Last updated: 11/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lixiana, Edoxaban (tosylate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases, Haematology-Hemostaseology
PIP number: EMEA-000788-PIP02-11-M09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Orodispersible tablet, Age-appropriate dosage form, other
Decision date: 06/01/2020, Last updated: 11/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP02-13-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 11/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002342-PIP01-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/04/2019, Last updated: 02/04/2020, Compliance check: X