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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100125-PIP01-21
  • PEMBROLIZUMAB
  • vibostolimab
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma)
  • Malignant CNS neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100136-PIP01-21
  • PEMBROLIZUMAB
  • quavonlimab
  • All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100454-PIP01-22
  • adagrasib
  • Treatment of all solid and haematological malignancies
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100374-PIP01-21
  • Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene
  • Treatment of frontotemporal dementia
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100295-PIP01-21
  • Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; (ABBV-154).
  • Treatment of polymyalgia rheumatica
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100190-PIP01-21
  • Ordesekimab
  • Treatment of coeliac disease
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100122-PIP01-21
  • olpasiran
  • Prevention of cardiovascular events
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100316-PIP01-21
  • latozinemab
  • Treatment of clinically symptomatic or pre-symptomatic frontotemporal dementia (FTD)
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100396-PIP01-21
  • sugemalimab
  • Treatment of non-small cell lung cancer (NSCLC)
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100199-PIP01-21
  • efgartigimod alfa
  • Treatment of Pemphigus
  • Dermatology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100301-PIP01-21
  • Anti-neonatal Fc receptor human monoclonal antibody(Nipocalimab )
  • Treatment of chronic inflammatory demyelinating polyradiculoneuropathy
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100309-PIP01-21
  • gantenerumab
  • Prevention of Alzheimer's disease
  • Not available at present
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100206-PIP01-21
  • EMPAGLIFLOZIN
  • Treatment of ischaemic heart disease
  • Jardiance
  • Jardiance
  • Endocrinology-Gynaecology-Fertility-metabolism
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100194-PIP01-21
  • sivopixant
  • Treatment of unexplained or refractory chronic cough
  • Pneumology - Allergology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100204-PIP01-21
  • verdiperstat
  • Treatment of Amyotrophic lateral sclerosis
  • Dazluma
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100184-PIP01-21
  • BENRALIZUMAB
  • Non-cystic fibrosis bronchiectasis with an eosinophilic phenotype
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Pneumology - Allergology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100135-PIP01-21
  • anti-CD40L humanized monoclonal antibody (SAR441344)
  • Treatment of Sjogren's Syndrome
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100368-PIP01-21
  • aumolertinib
  • Treatment of lung cancer
  • Ameile
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100279-PIP01-21
  • Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide
  • Diabetic retinopathy
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100163-PIP01-21
  • Vupanorsen (PF-07285557)
  • Treatment of Hypertriglyceridemia
  • Prevention of cardiovascular events
  • Not available at present
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
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