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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-101028-PIP01-23-M01 (update)	Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)	Prevention of cholera	Vaxchora	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	19/12/2023
MHRA-100197-PIP01-21-M02 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	01/05/2024
MHRA-100601-PIP01-22-M03 (update)	elasomeran imelasomeran DAVESOMERAN ANDUSOMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Spikevax Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.4-5 Spikevax Spikevax Spikevax bivalent Original/Omicron BA.1 Spikevax Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.4-5 Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.4-5 Spikevax bivalent Original/Omicron BA.4-5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB1.5	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	01/05/2024
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-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-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-100102-PIP01-21-M01 (update)	MOMETASONE FUROATE INDACATEROL ACETATE	Treatment of asthma	Atectura Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler Atectura Breezhaler Atectura 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	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100119-PIP01-21-M01 (update)	TEZACAFTOR IVACAFTOR	Treatment of Cystic Fibrosis	Symkevi Symkevi Symkevi	Pneumology - Allergology Other: Congenital, hereditary and neonatal diseases and abnormalities	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	18/03/2022
MHRA-100116-PIP01-21-M01 (update)	TEZACAFTOR ELEXACAFTOR IVACAFTOR	Treatment of Cystic Fibrosis	Kaftrio Kaftrio Trikafta Kaftrio 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	17/05/2022
MHRA-100229-PIP01-21-M01 (update)	NINTEDANIB	Treatment of fibrosing Interstitial Lung Diseases (ILD)	Ofev Vargatef Ofev Vargatef	Pneumology - Allergology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022
MHRA-100247-PIP01-21-M01 (update)	BEROTRALSTAT DIHYDROCHLORIDE	Treatment of hereditary angioedema	Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo Orladeyo	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/05/2022
MHRA-100294-PIP01-21-M01 (update)	BENRALIZUMAB	Treatment of asthma	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022
MHRA-100249-PIP01-21-M01 (update)	BUDESONIDE GLYCOPYRRONIUM BROMIDE FORMOTEROL FUMARATE DIHYDRATE	Treatment of asthma		Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100334-PIP01-21-M01 (update)	INDACATEROL ACETATE GLYCOPYRRONIUM BROMIDE MOMETASONE FUROATE	Treatment of asthma	Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100492-PIP01-22-M01 (update)	MOLGRAMOSTIM	Treatment of pulmonary alveolar proteinosis	Not available at present	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100535-PIP01-22-M01 (update)	UMECLIDINIUM BROMIDE FLUTICASONE FUROATE VILANTEROL TRIFENATATE	Treatment of asthma	Trelegy Ellipta Trelegy Ellipta/ Elebrato/Temybric Trelegy Ellipta	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
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

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