4948 results
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Human medicine European public assessment report (EPAR): Herceptin
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 28/08/2000, Revision: 42, Authorised, Last updated: 17/03/2023Herceptin Cancer Neoplasms Gastrointestinal Neoplasms Gastrointestinal Diseases Digestive System … Diseases Stomach Diseases Gastrointestinal Diseases Digestive System … also be used for: metastatic gastric (stomach) cancer, in combination … -
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Opinion/decision on a Paediatric investigation plan (PIP): Relamorelin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002323-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate oral dosage form, Solution for injection
Decision date: 09/09/2020, Last updated: 12/01/2023, Compliance check: XEMEA-002323-PIP02-19 Gastroentology-Hepatology … Relamorelin Therapeutic area Gastroentology-Hepatology Decision number P/0367/2020 … indication(s) Treatment of gastroparesis Route(s) of administration … -
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Opinion/decision on a Paediatric investigation plan (PIP): Remicade, infliximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: Infliximab, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 05/11/2010, Last updated: 20/12/2010, Compliance check: V, 16/09/2011Infliximab Gastroentology-Hepatology … infliximab Therapeutic area Gastroentology-Hepatology Decision number P/239/2010 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rebetol, Ribavirin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: Ribavirin, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution and Hard Capsules
Decision date: 15/08/2008, Last updated: 18/09/2008, Compliance check: V, 17/10/2008Ribavirin Gastroentology-Hepatology … Ribavirin Therapeutic area Gastroentology-Hepatology Decision number P/63/2008 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fasenra, Benralizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001214-PIP05-19, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for injection/infusion, Age-appropriate dosage form for parenteral use
Decision date: 08/09/2021, Last updated: 22/12/2022, Compliance check: XEMEA-001214-PIP05-19 Gastroentology-Hepatology … Benralizumab Therapeutic area Gastroentology-Hepatology Decision number P/0388/2021 … -
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Human medicine European public assessment report (EPAR): Zercepac
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 27/07/2020,
, 
, Revision: 8, Authorised, Last updated: 09/02/2023
Zercepac Cancer Neoplasms Gastrointestinal Neoplasms Gastrointestinal Diseases Digestive System … Diseases Stomach Diseases Gastrointestinal Diseases Digestive System … aromatase inhibitor; metastatic gastric (stomach) cancer, in combination … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cendakimab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002640-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 02/12/2022, Compliance check: XEMEA-002640-PIP01-19 Gastroentology-Hepatology … Cendakimab Therapeutic area Gastroentology-Hepatology Decision number P/0375/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Elafibranor
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001857-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/08/2020, Last updated: 10/08/2022, Compliance check: XEMEA-001857-PIP02-20 Gastroentology-Hepatology … Key facts Elafibranor Gastroentology-HepatologyP/0295/2020EMEA-001857-PIP02-20 Film-coated tablet Treatment … -
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Human medicine European public assessment report (EPAR): Trazimera
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/07/2018,, , Revision: 11, Authorised, Last updated: 17/10/2022
Trazimera Neoplasms Cancer Gastrointestinal Neoplasms Gastrointestinal Diseases Digestive System … Diseases Stomach Diseases Gastrointestinal Diseases Digestive System … aromatase inhibitors; metastatic gastric (stomach) cancer, in combination … -
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Opinion/decision on a Paediatric investigation plan (PIP): Expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000635-PIP01-09, Route(s) of administration: Intralesional use, Pharmaceutical form(s): Suspension for injection
Decision date: 19/02/2010, Last updated: 14/06/2022, Compliance check: XEMEA-000635-PIP01-09 Gastroentology-Hepatology … from adipose tissue (CX-401) Gastroentology-HepatologyP/20/2010EMEA-000635-PIP01-09 Suspension for injection … -
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Human medicine European public assessment report (EPAR): Ogivri
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 9, Authorised, Last updated: 30/09/2022
Ogivri Cancer Neoplasms Gastrointestinal Neoplasms Gastrointestinal Diseases Digestive System … Diseases Stomach Diseases Gastrointestinal Diseases Digestive System … aromatase inhibitor; metastatic gastric (stomach) cancer, in combination … -
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Opinion/decision on a Paediatric investigation plan (PIP): Selonsertib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001868-PIP03-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/09/2017, Last updated: 07/06/2022, Compliance check: XEMEA-001868-PIP03-16 Gastroentology-Hepatology … Key facts Selonsertib Gastroentology-HepatologyP/0252/2017EMEA-001868-PIP03-16 Film-coated tablet Treatment … -
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Human medicine European public assessment report (EPAR): Ontruzant
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 15/11/2017,, Revision: 14, Authorised, Last updated: 20/09/2022
Ontruzant Cancer Neoplasms Gastrointestinal Neoplasms Gastrointestinal Diseases Digestive System … Diseases Stomach Diseases Gastrointestinal Diseases Digestive System … aromatase inhibitors; metastatic gastric (stomach) cancer, in combination … -
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Human medicine European public assessment report (EPAR): Cyramza
Ramucirumab, Stomach Neoplasms
Date of authorisation: 19/12/2014, Revision: 15, Authorised, Last updated: 13/12/2022Digestive System Neoplasms Gastrointestinal Neoplasms Digestive System … Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Stomach … treat adult patients with: gastric cancer (cancer of the stomach … -
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Opinion/decision on a Paediatric investigation plan (PIP): sodium sulfate, potassium sulfate, magnesium sulfate heptahydrate
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: P/116/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 07/07/2010, Last updated: 29/07/2010, Compliance check: XP/116/2010 Gastroentology-Hepatology … magnesium sulfate heptahydrate Gastroentology-HepatologyP/116/2010P/116/2010 Oral solution Diseases of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001776-PIP03-17, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection, Age-appropriate dosage form for parenteral use
Decision date: 03/08/2018, Last updated: 06/01/2022, Compliance check: XEMEA-001776-PIP03-17 Gastroentology-Hepatology … Risankizumab Therapeutic area Gastroentology-Hepatology Decision number P/0230/2018 … -
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Human medicine European public assessment report (EPAR): Zaltrap
aflibercept, Colorectal Neoplasms
Date of authorisation: 01/02/2013, Revision: 13, Authorised, Last updated: 21/12/2022ltrap Intestinal Neoplasms Gastrointestinal Neoplasms Gastrointestinal Diseases Digestive System … -
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Opinion/decision on a Paediatric investigation plan (PIP): Linerixibat
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002800-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: XEMEA-002800-PIP01-20 Gastroentology-Hepatology … Linerixibat Therapeutic area Gastroentology-Hepatology Decision number P/0337/2020 … -
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Human medicine European public assessment report (EPAR): Erbitux
cetuximab, Head and Neck Neoplasms; Colorectal Neoplasms
Date of authorisation: 29/06/2004, Revision: 29, Authorised, Last updated: 25/05/2022lasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System … Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Intestinal Neoplasms Colonic … Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System … -
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Opinion/decision on a Paediatric investigation plan (PIP): magnesium sulfate heptahydrate (BLI800), Sodium sulphate anhydrou, potassium sulfate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000816-PIP02-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Concentrate for oral solution
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: XEMEA-000816-PIP02-10-M03 Gastroentology-Hepatology … sulfate Therapeutic area Gastroentology-Hepatology Decision number P/0159/2022 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bylvay, Odevixibat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002054-PIP01-16-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 13/05/2022, Last updated: 12/05/2023, Compliance check: XEMEA-002054-PIP01-16-M03 Gastroentology-Hepatology … Odevixibat Therapeutic area Gastroentology-Hepatology Decision number P/0147/2022 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Brazikumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001929-PIP01-16, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 19/12/2017, Last updated: 21/01/2021, Compliance check: XEMEA-001929-PIP01-16 Gastroentology-Hepatology … Brazikumab Therapeutic area Gastroentology-Hepatology Decision number P/0397/2017 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002218-PIP01-17, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 12/09/2018, Last updated: 07/10/2020, Compliance check: XEMEA-002218-PIP01-17 Gastroentology-Hepatology … SHP647) Therapeutic area Gastroentology-Hepatology Decision number P/0281/2018 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mirikizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002208-PIP01-17-M02, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: XEMEA-002208-PIP01-17-M02 Gastroentology-Hepatology … Key facts Mirikizumab Gastroentology-HepatologyP/0088/2022EMEA-002208-PIP01-17-M02 Concentrate for solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): Etrasimod L-arginine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002713-PIP01-19-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: XEMEA-002713-PIP01-19-M01 Gastroentology-Hepatology … facts Etrasimod L-arginine Gastroentology-HepatologyP/0053/2022EMEA-002713-PIP01-19-M01 Film-coated tablet Age-appropriate …