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Displaying 41 - 60 of 669
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100300-PIP01-21-M03 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100301-PIP05-23
  • Nipocalimab
  • Treatment of Idiopathic inflammatory myopathies
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-101118-PIP01-23
  • 5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7
  • Treatment of head and neck squamous cell carcinoma
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101115-PIP01-23
  • Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)
  • Treatment of Amyotrophic lateral sclerosis
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-100913-PIP01-23
  • mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV-2 (mRNA-1283)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100797-PIP01-22
  • Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)
  • Prevention of influenza disease
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100789-PIP01-22
  • Fazirsiran
  • Treatment of congenital alpha-1 antitrypsin deficiency
  • Not available at present
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100698-PIP01-22
  • Nemvaleukin Alfa
  • Treatment of all conditions included in the category of malignant neoplasms (except CNS, haematopoietic and lymphoid tissue)
  • Treatment of malignant neoplasms of the lymphoid tissue
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100562-PIP01-22
  • strontium-82 chloride/ rubidium-82 chloride
  • Visualisation of myocardial perfusion for diagnostic purposes
  • Ruby-Fill
  • Ruby-Fill
  • Ruby-Fill
  • Cardiovascular Diseases
  • Diagnostic
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100558-PIP01-22
  • milvexian
  • Prevention of thromboembolism in patients with cardiovascular disease
  • Not available at present
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100971-PIP01-23
  • Sipavibart (AZD3152)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100689-PIP01-22
  • Dersimelagon
  • Treatment of systemic sclerosis
  • Other: Autoimmune and immune dysfunction diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100680-PIP01-22
  • Influenza recombinant H7 haemagglutinin
  • Prevention of influenza infection
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100103-PIP01-21
  • Rozanolixizumab
  • Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease
  • Not available at present
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100920-PIP01-23
  • Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate
  • Prevention of disease caused by Streptococcus pneumoniae
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100594-PIP01-22
  • N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethyl-phenyl]-3,3-dimethylbutanamide
  • Treatment of focal onset seizures
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-101232-PIP01-23
  • palopegteriparatide
  • Treatment of hypoparathyroidism
  • Yorvipath
  • Yorvipath
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-101230-PIP01-23
  • teprotumumab
  • Treatment of thyroid eye disease
  • Not available at present
  • TEPEZZA
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101122-PIP01-23
  • ENFORTUMAB VEDOTIN
  • Treatment of head and neck epithelial malignant neoplasms
  • Padcev
  • Padcev
  • Padcev
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101100-PIP01-23
  • Derivative of a benzoimidazole substituted pyrimidine (PF-07220060)
  • Treatment of breast malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024