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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-102010-PIP01-25
  • PEGCETACOPLAN
  • Treatment of geographic atrophy secondary to age related macular degeneration.
  • Syfovre
  • Syfovre
  • Syfovre
  • Syfovre
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101786-PIP02-25
  • (R)-N-(3-(2-Chloro-5-fluorophenyl)-6-(5-cyano-[1,2,4]triazolo[1,5-a]pyridin-6-yl)-1-oxoisoindolin-4-yl)-3-fluoro-5-(trifluoromethyl)benzamide
  • Treatment of breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101439-PIP01-24-M02 (update)
  • Tolebrutinib
  • Treatment of Multiple Sclerosis
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101915-PIP01-25
  • Patritumab deruxtecan
  • Treatment of breast malignant neoplasms
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101881-PIP01-25
  • opevesostat
  • Treatment of prostate malignant neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101844-PIP01-25
  • SEMAGLUTIDE
  • Prevention of peripheral arterial disease
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101825-PIP01-25
  • AZD6793
  • Treatment of chronic obstructive pulmonary disease (COPD)
  • Pneumology - Allergology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101816-PIP01-25
  • Nipocalimab
  • Prevention of foetal and neonatal alloimmune thrombocytopenia
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101800-PIP01-25
  • OMEPRAZOLE MAGNESIUM
  • AMOXICILLIN TRIHYDRATE
  • RIFABUTIN
  • Treatment of Helicobacter spp. infection
  • Talicia
  • Talicia
  • Talicia
  • Gastroenterology-Hepatology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101759-PIP01-24
  • Darovasertib
  • Treatment of ocular melanoma
  • N/A
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101753-PIP01-24
  • Rilvegostomig
  • Treatment of gastric and gastro-oesophageal junction adenocarcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101744-PIP01-24
  • (12M)(1S,2S)-N-((63S,4S,Z)-11-ethyl-12-(2-((S)-1-methoxyethyl)-5-(4-methylpiperazin-1-yl)pyridin-3-yl)-10,10-dimethyl-5,7-dioxo-61,62,63,64,65,66-hexahydro-11H-8-oxa-2(4,2)-thiazola-1(5,3)-indola-6(1,3)-pyridazinacycloundecaphane-4-yl)-2-methylcyclopropane-1-carboxamide
  • Treatment of non-small cell lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101606-PIP01-24
  • telisotuzumab adizutecan (ABBV-400)
  • Treatment of gastric and gastroesophageal junction adenocarcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100878-PIP01-23-M01 (update)
  • VIBEGRON
  • Treatment of myoneurogenic bladder disorders
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Uro-Nephrology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100225-PIP01-21-M03 (update)
  • PARATHYROID HORMONE
  • Treatment of hypoparathyroidism
  • Natpar
  • Natpar
  • Natpar
  • Endocrinology-Gynaecology-Fertility-metabolism
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101761-PIP01-24
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage)
  • Prevention of influenza infection
  • Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Vaccines
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101789-PIP01-25
  • Vixarelimab
  • Treatment of idiopathic pulmonary fibrosis (IPF)
  • Pneumology - Allergology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101752-PIP01-24
  • BELZUTIFAN
  • Treatment of neuroendocrine tumours
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101750-PIP01-24
  • Tenapanor
  • Treatment of hyperphosphataemia
  • Xphozah
  • Phozevel
  • Uro-Nephrology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100326-PIP02-24
  • Gemcitabine (hydrochloride)
  • Treatment of malignant bladder neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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