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Displaying 81 - 100 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-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-100806-PIP01-22
  • ALPELISIB
  • Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Peritoneal cancer (excluding blastomas and sarcomas).
  • Piqray
  • Piqray
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
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-100832-PIP01-23-M01 (update)
  • LANADELUMAB
  • Prevention of attacks of idiopathic non-histaminergic angioedema (INHA).
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • Other: Genetic disease
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
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • Menveo
  • 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-100874-PIP01-23
  • PEMBROLIZUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
  • Treatment of Hodgkin lymphoma
  • Keytruda
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
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-100917-PIP01-23
  • efgartigimod alfa
  • Treatment of Bullous Pemphigoid
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
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 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
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-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 19/12/2023
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 19/12/2023
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 30/01/2024