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88 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
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Summary of opinion: Pemazyre (updated)
pemigatinib, opinion date: 28/01/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Sunitinib Accord
sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lumoxiti
moxetumomab pasudotox, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Inrebic
fedratinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Thiotepa Riemser
thiotepa, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Sogroya
somapacitan, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Nexpovio
selinexor, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Sirturo
bedaquiline, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Abiraterone Accord
abiraterone, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Orladeyo
berotralstat, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Epidyolex
cannabidiol, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020 -
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Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020 -
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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): Polivy (polatuzumab vedotin)
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab
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): Alprolix, eftrenonacog alfa
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): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP03-14-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/03/2020, Last updated: 03/08/2020, 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): 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): Namuscla, Mexiletine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002012-PIP01-16-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001397-PIP04-17-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet, Oral suspension
Decision date: 06/12/2019, Last updated: 01/04/2020, Compliance check: X