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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort ascending	Decision Type	Compliance Check	Compliance outcome	Date Published
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-100116-PIP01-21-M02 (update)	IVACAFTOR TEZACAFTOR ELEXACAFTOR	Treatment of cystic fibrosis	Kaftrio Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Trikafta Kaftrio Kaftrio Trikafta Trikafta Trikafta Trikafta Kaftrio	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100535-PIP01-22-M02 (update)	FLUTICASONE FUROATE UMECLIDINIUM BROMIDE VILANTEROL TRIFENATATE	Treatment of asthma	Trelegy Ellipta Trelegy Ellipta Trelegy Ellipta/ Elebrato Ellipta Trelegy Ellipta	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100645-PIP01-22-M01 (update)	AMIKACIN SULFATE	Treatment of Pseudomonas aeruginosa lung infection/colonisation in cystic fibrosis patients Treatment of non-tuberculous mycobacterial lung infection	Arikayce Arikayce Arikayce liposomal	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/06/2023
MHRA-100102-PIP01-21-M02 (update)	INDACATEROL ACETATE MOMETASONE FUROATE	Treatment of asthma	Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler and its duplicate authorization Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/08/2023
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-100894-PIP01-23	depemokimab	Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)		Pneumology - Allergology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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-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-100249-PIP01-21-M02 (update)	BUDESONIDE GLYCOPYRRONIUM BROMIDE FORMOTEROL FUMARATE DIHYDRATE	Treatment of asthma	Trixeo Aerosphere Trixeo Aerosphere Trixeo Aerosphere BREZTRI AEROSPHERE	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100141-PIP01-21-M01 (update)	BENRALIZUMAB	Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA FASENRA PEN	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100932-PIP01-23-M01 (update)	Peanut Flour	Treatment of peanut allergy	Palforzia PALFORZIA Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100932-PIP01-23-M02 (update)	Defatted powder of peanuts	Treatment of peanut allergy	Palforzia Palforzia Palforzia	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100989-PIP01-23-M01 (update)	DERMATOPHAGOIDES FARINAE DERMATOPHAGOIDES PTERONYSSINUS	Treatment of asthma Treatment of allergic rhinitis	ACARIZAX and associated names ACARIZAX ACARIZAX ACARIZAX ACARIZAX AMITEND ACARIZAX AITARO ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACARIZAX ACCARIZAX	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/04/2024
MHRA-101188-PIP01-23-M01 (update)	fosdenopterin	Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A	Nulibry	Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100156-PIP01-21-M01 (update)	FLUOCINOLONE ACETONIDE	Treatment of non-infectious uveitis Secondary prevention of non-infectious uveitis	ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru ILUVIEN Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 microgrammi impianto intravitreale in applicatore ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 microgram, intravitreaal implant in applicator Iluvien 190 mikrogram intravitrealt implantat i applikator ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze ILUVIEN 190 microgramas implante intravítreo em aplicador ILUVIEN 190 microgramos implante intravítreo en aplicador Iluvien 190 mikrogram intravitrealt implantat i applikator ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN fluocinolone acetonide 190 micrograms intravitreal implant in applicator	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		18/03/2022
MHRA-100279-PIP01-21	Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide	Diabetic retinopathy		Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		04/05/2022
MHRA-100370-PIP01-21-M01 (update)	EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS	Treatment of limbal stem cell deficiency due to ocular burns	Holoclar Holoclar Holoclar	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
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-100678-PIP01-22	Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)	Treatment of uveitic macular oedema	Not available at present	Ophthamology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023

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