Displaying 61 - 80 of 333
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100398-PIP01-21
  • ralmitaront
  • Treatment of schizophrenia
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100403-PIP01-21
  • Fusion protein composed of the first 2 immunoglobulin (Ig)-like domains of the human ROBO2 fused to human IgG1 Fc (PF-06730512)
  • Treatment of focal segmental glomerulosclerosis
  • Not available at present
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100257-PIP01-21
  • 2-[(4-{6-[(4-cyano-2-fluorobenzyl)oxy]pyridin-2-yl}piperidin-1-yl)methyl]-1-[(2S)-oxetan-2-ylmethyl]-1H-benzimidazole-6-carboxylic acid tris(hydroxymethyl)aminomethane salt (1:1)
  • PF-06882961
  • Treatment of Type 2 Diabetes Mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100253-PIP01-21
  • Zuranolone
  • Treatment of post-partum depression
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100242-PIP01-21
  • Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus.
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 07/12/2022
MHRA-100092-PIP01-21-M02 (update)
  • VENETOCLAX
  • Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue
  • Treatment of solid malignant tumours
  • Venclyxto
  • Vencylxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Venclyxto
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/11/2022
MHRA-100236-PIP01-21-M02 (update)
  • Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Prevention of disease caused by Streptococcus pneumoniae
  • Prevnar 20
  • Apexxnar
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/11/2022
MHRA-100236-PIP01-21-M01 (update)
  • Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Disease caused by Streptococcus pneumoniae
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/11/2022
MHRA-100200-PIP01-21-M01 (update)
  • REGORAFENIB
  • Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Stivarga
  • Stivarga
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 04/11/2022
MHRA-100516-PIP01-22
  • Toripalimab
  • Malignant neoplasms (except CNS, haematopoietic and lymphoid tissue and melanoma).
  • Not available at present
  • TUOYI
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/11/2022
MHRA-100480-PIP01-22
  • (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide
  • Treatment of mature B-cell malignancies
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100386-PIP01-21
  • patritumab deruxtecan
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100385-PIP01-21
  • datopotamab deruxtecan
  • Treatment of breast cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100384-PIP01-21
  • datopotamab deruxtecan
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100311-PIP01-21
  • Cetrelimab
  • Treatment of urothelial carcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100326-PIP01-21
  • GEMCITABINE HYDROCHLORIDE
  • Treatment of urothelial carcinoma
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100246-PIP01-21
  • MK-1026
  • Treatment of mature B-cell malignancies
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100176-PIP01-21
  • favezelimab
  • PEMBROLIZUMAB
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid-tissue-& melanoma)
  • Neoplasms of CNS
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100187-PIP01-21-M02 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100268-PIP01-21-M01 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022