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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-101090-PIP01-23
  • tiragolumab
  • Treatment of hepatocellular carcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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-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-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-100950-PIP01-23
  • lutetium-177 (177Lu) rhPSMA 10.1
  • Treatment of prostate cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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-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
MHRA-100829-PIP01-22
  • Edaravone
  • Treatment of Amyotrophic lateral sclerosis
  • Not available at this moment
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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