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Displaying 61 - 80 of 122
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Sort descending Compliance outcome Date Published
MHRA-100634-PIP01-22
  • Ceralasertib
  • Treatment of lung carcinoma (small cell and non-small cell carcinoma)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100186-PIP01-21
  • depemokimab
  • Treatment of chronic rhinosinusitus with nasal polyps (CRSwNP)
  • Depemokimab
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100316-PIP02-22
  • latozinemab
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100632-PIP01-22-M01 (update)
  • FLUCICLOVINE (18F)
  • Diagnosis of amino acid metabolism in solid malignant tumours
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Diagnostic
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100493-PIP01-22
  • BI 765128 - humanized monoclonal antibody of IgG1 subtype targeting NRP1
  • Diabetic retinopathy
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100565-PIP01-22
  • MDM2-p53 antagonist
  • Treatment of liposarcoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100555-PIP01-22
  • vepsitamab
  • Treatment of gastric cancer and gastro-oesophageal junction cancer
  • Treatment of colorectal carcinoma
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100599-PIP01-22
  • Flortaucipir F18
  • Diagnosis of Alzheimer's disease
  • Tauvid
  • Tauvid
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100583-PIP01-22
  • SACITUZUMAB GOVITECAN
  • Treatment of lung carcinoma (small-cell and non-small-cell carcinoma)
  • Trodelvy
  • Trodelvy
  • Trodelvy
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100602-PIP01-22
  • monalizumab
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100603-PIP01-22
  • Oleclumab
  • Treatment of lung cancer
  • Treatment of pancreatic cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
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-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-100598-PIP01-22
  • Cobolimab
  • Treatment of lung cancer
  • Not available at present
  • Oncology
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-100733-PIP01-22
  • Botulinum toxin type E
  • Treatment of skin wrinkling
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100699-PIP01-22-M01 (update)
  • DIROXIMEL FUMARATE
  • Treatment of Multiple Sclerosis
  • Vumerity
  • Vumerity
  • Vumerity
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100029-PIP01-21-M01 (update)
  • RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE
  • COVID-19 vaccine (Ad26.COV2-S [recombinant])
  • Prevention of coronavirus disease-2019 (COVID-19)
  • COVID-19 vaccine Janssen
  • Jcovden (previously COVID-19 Vaccine Janssen)
  • Infectious diseases
  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100740-PIP01-22
  • Xevinapant
  • Treatment of head and neck epithelial malignant neoplasms
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100738-PIP01-22
  • PEMIGATINIB
  • Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023