English (EN) (81.94 KB - PDF) First published: 23/02/2018Last updated: 11/06/2024
English (EN) (81.94 KB - PDF) First published: 04/08/2021Last updated: 11/06/2024
Intuniv treatment must be started by a doctor specialised in childhood or adolescent behavioural problems. Before starting treatment, the doctor should carry out checks to see whether the patient is at risk of side effects of the medicine (particularly …
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the foundation for the development of safe and effective medicines in Europe. ACT EU is …
Invented name Evusheld Active Substance Therapeutic area Infectious diseases Decision number P/0119/2023 PIP number EMEA-003079-PIP01-22 Pharmaceutical form(s) Solution for injection Condition(s) / indication(s) Prevention of Coronavirus disease 2019 ( …
This one-day hybrid Big Data Steering Group (BDSG) workshop will bring together representatives of regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and health technology assessment bodies to address the following …
Active Substance Vilobelimab Therapeutic area Infectious diseases Decision number P/0118/2023 PIP number EMEA-003080-PIP03-22 Pharmaceutical form(s) Concentrate for solution for infusion Condition(s) / indication(s) Treatment of Coronavirus disease 2019 ( …
Active Substance AV2-cVLP-RBD SARS-CoV-2 (ABNCoV2) Therapeutic area Infectious diseases Vaccines Decision number P/0139/2023 PIP number EMEA-003184-PIP01-22 Pharmaceutical form(s) Dispersion for injection Condition(s) / indication(s) Prevention of …
Parsabiv has been investigated in three main studies involving 1,706 patients on haemodialysis who had long-term kidney disease and secondary hyperparathyroidism. The first two studies compared Parsabiv with placebo (a dummy treatment), and the third study …
P/0192/2023 : EMA decision of 26 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for vatiquinone (EMEA-001238-PIP03-21-M01) AdoptedReference Number: EMA/186780/2023
P/0189/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cholera vaccine, live attenuated, oral (strain CVD 103-HgR) (Vaxchora), (EMEA-001490-PIP01-13-M04) AdoptedReference Number: EMA/ …
P/0190/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP04-19-M02) AdoptedReference Number: EMA/201814/2023
P/0177/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M10) AdoptedReference Number: EMA/171114/2023
P/0178/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for itolizumab (EMEA-003208-PIP02-22) AdoptedReference Number: EMA/171157/2023
P/0168/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for albaconazole (EMEA-003279-PIP01-22) AdoptedReference Number: EMA/160497/2023
P/0184/2023 : EMA decision of 19 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aticaprant (EMEA-003251-PIP01-22) AdoptedReference Number: EMA/171173/2023
P/0198/2023 : EMA decision of 22 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanised VHH-type bispecific antibody against complement.....(EMEA-003302-PIP01-22) …
P/0161/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for diclofenac / thiocolchicoside (EMEA-003339-PIP02-23) AdoptedReference Number: EMA/170255/2023
P/0181/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for 1-((S)-4-((R)-7-(6-amino-4-methyl-3- (trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro-2-(((S)-1-methylpyrrolidin-2-yl).....(EMEA-003364-PIP02-22) AdoptedReference …
Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20) Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20) Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57) Palmitoyl-KSSKKLLMGTLGIVCPICSQKP (HPV-16 E7 82-98) Palmitoyl-KSS-LLMGTLGIV (HPV-16 E7 82-90) Palmitoyl-KSS- …
