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Displaying 661 - 680 of 783
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
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
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
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
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
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
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
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
MHRA-100334-PIP01-21-M01 (update)
  • INDACATEROL ACETATE
  • GLYCOPYRRONIUM BROMIDE
  • MOMETASONE FUROATE
  • Treatment of asthma
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100321-PIP01-21-M01 (update)
  • GUSELKUMAB
  • Chronic idiopathic arthritis (including rheumatoid, psoriatic, ankylosing spondylitis and JIA)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100286-PIP01-21-M01 (update)
  • USTEKINUMAB
  • Treatment of ulcerative colitis
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100198-PIP01-21-M01 (update)
  • RURIOCTOCOG ALFA PEGOL
  • Treatment and prophylaxis of bleeding in patients with haemophilia A
  • Adynovi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100347-PIP01-21
  • Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)
  • Prevention of lower respiratory track disease caused by RSV via maternal immunisation.
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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
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
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
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
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
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
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