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Displaying 81 - 100 of 122
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
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
MHRA-100301-PIP02-22
  • Nipocalimab
  • Treatment of Bullous Pemphigoid
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
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-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 19/12/2023
MHRA-100801-PIP01-22
  • eplontersen
  • Treatment of transthyretin-mediated amyloidosis
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100933-PIP01-23
  • camlipixant
  • Treatment of unexplained or chronic refractory cough
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-101019-PIP01-23
  • Treprostinil Palmitil
  • Treatment of pulmonary hypertension due to lung disease and/or hypoxia.
  • Not available at present
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100873-PIP01-23
  • Meningococcal Group A, C, W-135 and Y conjugate vaccine
  • Meningococcal meningitis
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  • Menveo
  • Menveo
  • Menveo
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  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100848-PIP01-23
  • messenger RNA encoding Cas9, single guide RNA targeting the human TTR gene
  • Treatment for transthyretin amyloidosis (ATTR)
  • Not available at present
  • Neurology
  • Cardiovascular Diseases
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-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 19/12/2023
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 19/12/2023