Displaying 541 - 560 of 782
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100069-PIP01-21
  • RIBOCICLIB
  • Treatment of neuroblastoma
  • KISQALI
  • KISQALI
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100470-PIP01-22
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,
  • Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100372-PIP01-21
  • concizumab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100355-PIP02-22
  • Fenebrutinib
  • Treatment of multiple sclerosis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100234-PIP01-21
  • (S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide
  • Treatment of dilated cardiomyopathy due to lamin A/C gene mutations
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100075-PIP01-21
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
  • Not available at present
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100019-PIP01-21
  • 2-(3-(4-(1H-INDAZOL-5-YLAMINO)QUINAZOLIN-2-YL)PHENOXY)-N-ISOPROPYLACETAMIDE-METHANE SULFONIC ACID SALT
  • Treatment of chronic Graft versus Host Disease (cGVHD)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/10/2022
MHRA-100177-PIP01-21-M01 (update)
  • INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN
  • INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN
  • Prevention of influenza
  • FLUCELVAX TETRA
  • FLUCELVAX TETRA
  • FLUCELVAX QUADRIVALENT
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX TETRA
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 21/10/2022
MHRA-100243-PIP01-21
  • DAPAGLIFLOZIN
  • 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)
  • Prevention of cardiovascular events in patients with chronic heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 21/10/2022
MHRA-100035-PIP01-21
  • POVIDONE-IODINE
  • ISOPROPYL ALCOHOL
  • Prevention of infection prior to invasive procedures
  • PurPrep
  • Other: Antiseptic
W: decision granting a waiver in all age groups for the listed condition(s). No 21/10/2022
MHRA-100431-PIP01-22
  • derivative of pyrrolopyrimidine
  • Prevention of cardiovascular events in patients with heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100185-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of cold agglutinin disease
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100125-PIP01-21
  • PEMBROLIZUMAB
  • vibostolimab
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma)
  • Malignant CNS neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100136-PIP01-21
  • PEMBROLIZUMAB
  • quavonlimab
  • All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100490-PIP01-22-M01 (update)
  • nirsevimab (MEDI8897)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
  • Beyfortus
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100164-PIP01-21-M01 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100149-PIP01-21-M01 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • TBD - Approval not yet granted
  • TBD - Approval not yet granted
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100352-PIP01-21-M01 (update)
  • AVAPRITINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • AYVAKYT
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100377-PIP01-21-M01 (update)
  • ACALABRUTINIB
  • Treatment of mature B cell neoplasms
  • calquence
  • calquence
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100370-PIP01-21-M01 (update)
  • EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS
  • Treatment of limbal stem cell deficiency due to ocular burns
  • Holoclar
  • Holoclar
  • Holoclar
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022