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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101149-PIP01-23-M01 (update)
  • elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase)
  • Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome)
  • Vimizim 1mg/ml concentrate for solution for infusion
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100406-PIP01-21-M02 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100249-PIP01-21-M02 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM BROMIDE
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100625-PIP01-22-M01 (update)
  • RISANKIZUMAB
  • Treatment of psoriasis
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100409-PIP01-21-M01 (update)
  • autologous dendritic cells pulsed with autologous tumour cell lysate
  • Treatment of high grade glioma
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100327-PIP01-21-M02 (update)
  • SELPERCATINIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Retsevmo
  • Retsevmo
  • Retevmo
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100288-PIP01-21-M02 (update)
  • DENOSUMAB
  • Treatment of osteoporosis
  • Prolia
  • Prolia
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100270-PIP01-21-M01 (update)
  • crinecerfont
  • Treatment of congenital adrenal hyperplasia
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100236-PIP01-21-M03 (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
  • Apexxnar
  • Prevnar 20
  • Apexxnar
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101079-PIP01-23-M01 (update)
  • ZANUBRUTINIB
  • Treatment of lymphoplasmacytic lymphoma
  •  Treatment of mature B-cell neoplasms (excluding lymphoplasmacytic lymphoma)
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100521-PIP01-22-M02 (update)
  • Evinacumab
  • Treatment of elevated cholesterol
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100897-PIP01-23-M01 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis
  • Not yet defined
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100758-PIP01-22-M01 (update)
  • BEZLOTOXUMAB
  • Prevention of recurrence of Clostridioides difficile infection
  • ZINPLAVA
  • ZINPLAVA
  • ZINPLAVA
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100098-PIP01-21-M02 (update)
  • ATALUREN
  • Treatment of dystrophinopathy
  • Translarna
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100465-PIP01-22-M02 (update)
  • efanesoctocog alfa
  • Treatment of congenital haemophilia A
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100995-PIP01-23
  • LysoPhosphatidic Acid receptor 1 (LPA1) antagonist (BMS-986278)
  • Treatment of fibrosing Interstitial Lung Diseases (ILD)
  • Pneumology - Allergology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100301-PIP04-23
  • Nipocalimab
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100301-PIP03-23
  • Nipocalimab
  • Treatment of Sjögren’s syndrome
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100974-PIP01-23
  • BOTULINUM TOXIN TYPE A
  • Treatment of skin wrinkling
  • Not yet defined
  • Other: Aesthetics
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100834-PIP01-23
  • SOTORASIB
  • Treatment of colorectal carcinoma
  • Lumykras
  • Lumykras
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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