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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101059-PIP01-23
  • [(2R)-2,3-bis[[(Z)-octadec-9-enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride)
  • Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20) / Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20) / Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57) / Palmitoyl-KSS-KKLLMGTLGIVCPICSQKP(HPV-16 E7 82-98) / Palmitoyl-KSS-LLMGTLGIV (HPV-16 E7 82-90) /Palmitoyl-KSS-ELQTTIHDIILECVYCKQQLL (HPV-16 E6 25-45)
  • Treatment of human papilloma virus (HPV) type 16 positive malignancies
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100980-PIP01-23
  • 1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro- 2-(((S)-1-methylpyrrolidin-2-yl)methoxy)quinazolin-4-yl)-3-methylpiperazin-1-yl)prop- 2-en-1-one adipate
  • Treatment of non-small cell lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100969-PIP01-23
  • V940 (mRNA-4157), Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens
  • Treatment of lung cancer
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101287-PIP01-23
  • SUMATRIPTAN
  • NAPROXEN SODIUM
  • Treatment of migraine headaches
  • Suvexx 85 mg/500 mg film-coated tablets
  • FI, DK, HU, NO, SE: Nomigrin EE, LT, LV: Migsun PL: Frimig Duo
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101034-PIP01-23
  • Belrestotug
  • GSK4428859A
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100978-PIP01-23
  • Genetically detoxified Pertussis Toxin (PTgen) and Pertussis Filamentous Haemagglutinin (FHA)
  • Prevention of Pertussis disease
  • Pertagen
  • Pertagen
  • Pertagen
  • Pertagen aPgen
  • Vaccines
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100858-PIP01-23
  • sabatolimab
  • Treatment of myelodysplastic syndromes
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101030-PIP01-23
  • Inhibitor of receptor-interacting serine/threonine-protein kinase 1 (RIPK1) (SAR443820)
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100544-PIP01-22-M02 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100840-PIP01-23-M01 (update)
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100369-PIP01-21-M02 (update)
  • MIGALASTAT HYDROCHLORIDE
  • Treatment of Fabry disease
  • Galafold 123 mg capsules
  • Galafold
  • Galafold
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101073-PIP01-23-M01 (update)
  • MIRABEGRON
  • Treatment of idiopathic overactive bladder
  • BETMIGA
  • MYRBETRIQ / MYRBETRIQ GRANULES
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100669-PIP01-22-M02 (update)
  • RILPIVIRINE
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100512-PIP01-22-M01 (update)
  • DAPAGLIFLOZIN
  • Treatment of Type 1 Diabetes Mellitus
  • Forxiga
  • Forxiga
  • Endocrinology-Gynaecology-Fertility-metabolism
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100547-PIP01-22-M02 (update)
  • PEGINTERFERON BETA-1A
  • Treatment of multiple sclerosis.
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Plegridy
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101000-PIP01-23-M01 (update)
  • Rilzabrutinib
  • Treatment of Immune thrombocytopenia
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100440-PIP01-22-M02 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • BICTEGRAVIR
  • Treatment of Human immunodeficiency virus (HIV) infection
  • Biktarvy
  • Biktarvy
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100336-PIP01-21-M02 (update)
  • Soticlestat
  • Treatment of Dravet Syndrome
  • Treatment of Lennox-Gastaut Syndrome
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100276-PIP01-21-M03 (update)
  • BRODALUMAB
  • Treatment of psoriasis
  • Kyntheum
  • Kyntheum
  • Lumicef
  • Siliq
  • Kyntheum
  • Kyntheum
  • Kyntheum
  • Dermatology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100225-PIP01-21-M02 (update)
  • PARATHYROID HORMONE
  • Treatment of hypoparathyroidism
  • Natpar
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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