For help on how to get the results you want, see our search tips.
306 results
Medicine
Shortages Remove Shortages filter
Summaries of opinion Remove Summaries of opinion filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Medicine type
Orphan medicine Remove Orphan medicine filter
Additional monitoring Remove Additional monitoring filter
Exceptional circumstances Remove Exceptional circumstances filter
Biosimilar Remove Biosimilar filter
Categories
Human Remove Human filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Supemtek, Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype), Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype), Recombinant Influenza Hemagglutinin-strain B (Victoria lineage), Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage) (RIV4)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002418-PIP01-18-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 18/03/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001314-PIP01-12-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Holoclar, Ex vivo expanded autologous human corneal epithelium cells containing stem cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001082-PIP02-11-M03, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Living tissue equivalent
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Kesimpta, Ofatumumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002397-PIP01-18-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, Palbociclib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002146-PIP01-17-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard, Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Quviviq, Daridorexant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-002121-PIP03-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Yescarta, Axicabtagene ciloleucel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002010-PIP01-16-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001860-PIP03-16-M07, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP04-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Truberzi, Eluxadoline
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001579-PIP01-13-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Nulibry, Fosdenopterin (ORGN001)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001491-PIP01-13-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: V, 15/10/2021 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, Inotuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001429-PIP01-13-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Spravato, Esketamine (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001428-PIP03-15-M02, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Galafold, Migalastat hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001194-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Iclusig, Ponatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001186-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate formulation
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mayzent, Siponimod (hemifumarate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000716-PIP01-09-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/04/2022, Last updated: 17/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Arikayce liposomal, Amikacin sulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000525-PIP01-08-M08, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Nebuliser dispersion
Decision date: 13/04/2022, Last updated: 17/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Imdevimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002965-PIP01-21-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 03/02/2022, Last updated: 17/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Casirivimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002964-PIP01-21-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 03/02/2022, Last updated: 17/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): VidPrevtyn Beta, SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002915-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution and emulsion for emulsion for injection
Decision date: 14/02/2022, Last updated: 17/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cystadrops, Cysteamine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000322-PIP01-08-M06, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 03/02/2022, Last updated: 14/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mylotarg, gemtuzumab ozogamicin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001733-PIP02-15-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 31/01/2022, Last updated: 14/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rienso, Ferumoxytol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-000373-PIP02-09-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 13/04/2022, Last updated: 13/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vocabria, Cabotegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001418-PIP01-13-M04, Route(s) of administration: Intramuscular use, Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Film-coated tablet, Prolonged-release suspension for injection
Decision date: 31/01/2022, Last updated: 12/04/2023, Compliance check: X