EMEA-000207-PIP01-08-M08
P/0206/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for treprostinil (Remodulin) (EMEA-000207-PIP01-08-M08) Reference Number: EMA/236607/2023
P/0206/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for treprostinil (Remodulin) (EMEA-000207-PIP01-08-M08) Reference Number: EMA/236607/2023
P/0209/2023: EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten and associated names), (EMEA-000347-PIP02-16-M05) Reference Number: EMA/236606/2023
P/0196/2022 : EMA decision of 9 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole (Noxafil), (EMEA-000468-PIP02-12-M07) AdoptedReference Number: EMA/273998/2022
P/0240/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for givinostat (EMEA-000551-PIP04-21-M02) Reference Number: EMA/264176/2023
P/0234/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ponesimod (Ponvory), (EMEA-000798-PIP01-09-M04) Reference Number: EMA/235934/2023
P/0211/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed PIP for adsorbed modified allergen extract of a mixture of 50% dermatophagoides pteronyssinus and 50% dermatophagoides farinae (EMEA-000902-PIP01-10-M01) Reference …
P/0212/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for brodalumab (Kyntheum), (EMEA-001089-PIP02-13-M04) Reference Number: EMA/236234/2023
P/0221/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for landiolol (hydrochloride) (Rapibloc, Landiobloc, Raploc, Runrapiq), (EMEA-001150-PIP02-13-M05) Reference Number: EMA/236236/2023
P/0243/2023 : EMA decision of 16 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for birch bark extract (Filsuvez), (EMEA-001299-PIP03-17-M02) Reference Number: EMA/273941/2023
P/0202/2023 : EMA decision of 13 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant), (EMEA-001220-PIP01-11-M08) Reference Number: EMA/241941/2023
P/0203/2023 : EMA decision of 13 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for efinaconazole (EMEA- 001627-PIP01-14-M03) Reference Number: EMA/241957/2023
P/0242/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy), (EMEA-001766-PIP01-15-M05) Reference Number: EMA/250921/2023
P/0237/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M06) Reference Number: EMA/236245/2023
P/0186/2023 : EMA decision of 5 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tralokinumab (Adtralza), (EMEA-001900-PIP02-17-M07) Reference Number: EMA/175833/2023
P/0217/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dienogest / ethinylestradiol (EMEA-002229-PIP02-21-M01) Reference Number: EMA/238158/2023
P/0214/2023: EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cenobamate (Ontozry), (EMEA-002563-PIP02-19-M02) Reference Number: EMA/256562/2023
Deferoxamine (mesylate) histidine tryptophan aspartic acid n-acetyl-histidine (monohydrate) glycine alpha-ketoglutaric acid arginine potassium chloride magnesium chloride (hexahydrate) calcium chloride (dihydrate) sodium chloride alanine 3,4-dimethoxy-N- …
histidine tryptophan aspartic acid n-acetyl-histidine (monohydrate) glycine alpha-ketoglutaric acid arginine potassium chloride magnesium chloride (hexahydrate) calcium chloride (dihydrate) sodium chloride alanine 3,4-dimethoxy-N-methylbenzohydroxamic acid …
P/0215/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for denecimig (EMEA- 002762-PIP02-20-M01) Reference Number: EMA/236605/2023
P/0235/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for sotrovimab (Xevudy), (EMEA-002899-PIP01-20-M02) Reference Number: EMA/236247/2023