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Displaying 1 - 20 of 107
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort ascending Decision Type Compliance Check Compliance outcome Date Published
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 17/05/2022
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 27/09/2022
MHRA-100587-PIP01-22
  • lusvertikimab
  • Treatment of Sjögren’s syndrome
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100850-PIP01-23
  • deucravacitinib
  • Treatment of Sjogren's Syndrome
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100927-PIP01-23
  • Namilumab
  • Treatment of sarcoidosis
  • Not available at present
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
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 19/12/2023
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 19/05/2022
MHRA-100404-PIP01-21
  • insulin icodec
  • SEMAGLUTIDE
  • Treatment of type 2 diabetes mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 07/12/2022
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 30/01/2024
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 18/03/2022
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 29/07/2022
MHRA-100431-PIP01-22
  • derivative of pyrrolopyrimidine
  • Prevention of cardiovascular events in patients with heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100243-PIP01-21
  • DAPAGLIFLOZIN
  • 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)
  • Prevention of cardiovascular events in patients with chronic heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 21/10/2022
MHRA-100234-PIP01-21
  • (S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide
  • Treatment of dilated cardiomyopathy due to lamin A/C gene mutations
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100572-PIP01-22
  • autologous bone marrow-derived mononuclear cell enriched white blood cells
  • Treatment of chronic limb-threatening ischemia
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100577-PIP01-22
  • ziltivekimab
  • Treatment of heart failure
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100684-PIP01-22
  • Clazakizumab
  • Prevention of cardiovascular events in patients with atherosclerosis
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
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 29/07/2022
MHRA-100055-PIP01-21
  • Edaravone
  • Treatment of Amyotrophic lateral sclerosis
  • Radicava
  • Radicut
  • Radicut
  • Radicut
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 03/11/2021
MHRA-100074-PIP01-21
  • GABAPENTIN
  • Treatment of Postherpetic Neuralgia
  • Gralise
  • Neurology
  • Pain
W: decision granting a waiver in all age groups for the listed condition(s). No 17/12/2021