P/0208/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efgartigimod alfa (EMEA-002597-PIP08-22) Reference Number: EMA/253550/2023
P/0216/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for (S)-lactic acid (EMEA-003247-PIP02-23) Reference Number: EMA/234839/2023
P/0236/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for Derivative of (3S,3'S,3a'S,10a'S)-3'- phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline-3,2'-pyrrolo[2',3':4,5] …
The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or runny nose and blocked sinuses, nausea (feeling sick …
The active substance in Yentreve, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor (SNRI). It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in …
Duloxetine Lilly is available as gastroresistant capsules (30 mg and 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being …
This information session explains and showcases the latest developments and bug fixes deployed in the PLM Portal web based electronic Application Form (eAF), with a special focus on the add package feature. The eAF add package functionality allows the …
The focus of the Quality Innovation Group's (QIG) fourth listen-and-learn focus group meeting with representatives from academia and industry is on: Platforms for medicinal products manufactured using prior knowledge, such as common manufacturing …
EMA is organising a LinkedIn live discussion about ACT-EU, the Accelerating Clinical Trials in the EU initiative, with Peter Arlett, Head of Data Analytics and Methods Task Force, and Marianne Lunzer, chair of the Heads of Medicines Agencies (HMA) Clinical …
Agenda of the PRAC meeting 8-11 July 2024 DraftReference Number: EMA/PRAC/276333/2024
The report is based on a 2023 EMA exercise in monitoring submissions delays. This involved encouraging applicants to be proactive in their communication to EMA. Applicants had been informed of this exercise in advance. EMA's focus group on submission …
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/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
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