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31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, PM: decision on the application for modification of an agreed PIP, P/0306/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277), RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0323/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fc- and CDR-modified humanized monoclonal antibody against C5, PM: decision on the application for modification of an agreed PIP, P/0261/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524), PM: decision on the application for modification of an agreed PIP, P/0285/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Balovaptan, PM: decision on the application for modification of an agreed PIP, P/0259/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): andexanet alfa, PM: decision on the application for modification of an agreed PIP, P/0243/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tralokinumab, PM: decision on the application for modification of an agreed PIP, P/0250/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), PM: decision on the application for modification of an agreed PIP, P/0260/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human alpha-galactosidase A (PRX 102), PM: decision on the application for modification of an agreed PIP, P/0286/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir,cobicistat,emtricitabine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0310/2018