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125 results
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Summary of opinion: Nexviadyme
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 02/08/2021 -
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Summary of opinion: Flynpovi
eflornithine, sulindac, opinion date: 24/06/2021, Negative, Last updated: 23/07/2021 -
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Summary of opinion: Emdocam
meloxicam, opinion date: 17/02/2021, Positive, Last updated: 19/02/2021 -
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Summary of opinion: Emdocam
meloxicam, opinion date: 17/02/2021, Positive, Last updated: 19/02/2021 -
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Summary of opinion: Lextemy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Abiraterone Krka
abiraterone acetate, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Koselugo
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Vosevi
sofosbuvir, velpatasvir, voxilaprevi, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Deltyba
delamanid, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Brukinsa (new)
zanubrutinib, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Adempas (new)
riociguat, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Hukyndra (new)
adalimumab, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Rivaroxaban Mylan (new)
rivaroxaban, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Libmyris (new)
adalimumab, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Sugammadex Mylan (new)
sugammadex, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Deltyba, Delamanid (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001113-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 14/08/2019, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Praxbind, idarucizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001438-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 17/04/2019, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi (updated)
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: 16/09/2021, Compliance check: V, 16/10/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adempas, riociguat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000718-PIP01-09-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral liquid
Decision date: 04/11/2016, Last updated: 16/09/2021, Compliance check: V, 11/12/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000142-PIP02-09-M10, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Powder and gel for gel
Decision date: 05/11/2020, Last updated: 09/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Powder for concentrate for solution for infusion
Decision date: 09/08/2021, Last updated: 19/08/2021, 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)
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: 19/08/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002152-PIP01-17-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Concentrate for solution for infusion
Decision date: 22/10/2020, Last updated: 23/07/2021, 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-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 21/10/2020, Last updated: 21/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Lamzede, velmanase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001056-PIP02-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 23/10/2020, Last updated: 21/07/2021, Compliance check: X