4906 results
Keyword Noxap - Gas Remove keyword
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Orphan designation: G17(9) gastrin-Diphtheria Toxoid Conjugate for: Treatment of gastric cancer
Date of designation: 28/01/2003, Positive, Last updated: 21/09/2009G17(9) gastrin-Diphtheria Toxoid Conjugate Overview … United Kingdom, for G17(9) gastrin-diphtheria toxoid conjugate for the … conjugate for the treatment of gastric cancer. The sponsorship was … -
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Orphan designation: G17(9) gastrin-Diphtheria Toxoid Conjugate for: Treatment of pancreatic cancer
Date of designation: 24/01/2003, Positive, Last updated: 21/09/2009G17(9) gastrin-Diphtheria Toxoid Conjugate Overview … United Kingdom, for G17(9) gastrin-diphtheria toxoid conjugate for the … new mode of action, G17(9) gastrin-diphtheria toxoid conjugate may be of … -
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Withdrawn application: Gastromotal
date of withdrawal: 05/11/2007, Initial authorisation, Last updated: 16/11/2007Gastromotal: Withdrawn application … MARKETING APPLICATION for GASTROMOTAL International non-proprietary … marketing authorisation for Gastromotal, for in vivo diagnosis of … -
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Orphan designation: Cysteamine bitartrate (gastroresistant) (mercaptamine) for: Treatment of Huntington’s disease
Date of designation: 29/07/2014, Positive, Last updated: 01/09/2014Cysteamine bitartrate (gastroresistant) (mercaptamine) Overview … Procysbi (cysteamine bitartrate gastro-resistant capsules) in the EU for the … facts Cysteamine bitartrate (gastroresistant) (mercaptamine)Treatment … -
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Orphan designation: Cysteamine bitartrate (gastroresistant) (mercaptamine) for: Treatment of pancreatic cancer
Date of designation: 26/03/2014, Positive, Last updated: 06/05/2014Cysteamine bitartrate (gastroresistant) (mercaptamine) Overview … facts Cysteamine bitartrate (gastroresistant) (mercaptamine)Treatment … Cysteamine bitartrate (gastroresistant) (mercaptamine … -
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Orphan designation: Recombinant dog gastric lipase for: Treatment of cystic fibrosis
Date of designation: 09/07/2003, Positive, Last updated: 29/10/2003Recombinant dog gastric lipase Overview On 9 July … France, for recombinant dog gastric lipase for the treatment … supplements. Recombinant dog gastric lipase might be of potential … -
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Orphan designation: Refusal of orphan designation for the treatment of pancreatic cancer
Date of refusal of designation: 16/07/2010, Negative, Last updated: 05/08/2010Gastrin 17C diphtheria toxoid conjugate … designation application for gastrin 17C diphtheria toxoid conjugate … evidence to justify a claim that gastrin 17C diphtheria toxoid conjugate … -
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Orphan designation: Cysteamine bitartrate (gastroresistant) (mercaptamine) for: Treatment of cystinosis
Date of designation: 20/09/2010, Positive, Last updated: 10/10/2013Cysteamine bitartrate (gastroresistant) (mercaptamine … designation Cysteamine bitartrate (gastroresistant) for the treatment of cystinosis … Cysteamine bitartrate (gastroresistant) for the treatment of cystinosis … -
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Combination Herbal medicinal product: Species digestivae and stomachicae
Herbal tea combinations for use in gastrointestinal complaints, F: Assessment finalised, Last updated: 21/11/2022digestivae and stomachicae Gastrointestinal disorders … tea combinations for use in gastrointestinal complaints Gastrointestinal disordersF: Assessment finalised … tea combinations for use in gastrointestinal complaints … -
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Veterinary medicine European public assessment report (EPAR): Rabitec
attenuated live rabies vaccine virus, strain SPBN GASGAS, Red foxes (Vulpes vulpes); Raccoon dogs (Nyctereutes procyonoides)
Date of authorisation: 01/12/2017, Revision: 3, Authorised, Last updated: 07/01/2021vaccine virus, strain SPBN GASGAS International non-proprietary … Rabies virus, strain SPBN GASGAS, live – 106.8 to 108.1 FFU … vaccine virus, strain SPBN GASGAS … -
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Summary of opinion: Rabitec
Rabies vaccine (live, oral) for foxes and raccoon dogs, opinion date: 23/01/2020, Positive, Last updated: 24/01/2020vaccine virus, strain SPBN GASGAS … -
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Orphan designation: Chimeric peptide of human glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues linked to a human immunoglobulin Fc fragment for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 16/05/2022, Positive, Last updated: 14/12/2022glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues … peptide-1 (GLP-1) and the gastric inhibitory polypeptide (GIP … glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues … -
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Orphan designation: Chimeric peptide of human glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues linked to a human immunoglobulin Fc fragment for: Treatment of primary sclerosing cholangitis
Date of designation: 10/12/2021, Positive, Last updated: 28/04/2022glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues … glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues … glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues … -
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Orphan designation: Chimeric peptide of human glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues linked to a human immunoglobulin Fc fragment for: Treatment of primary biliary cholangitis
Date of designation: 14/01/2022, Positive, Last updated: 15/06/2022glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues … glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues … glucagon-like peptide-1, glucagon and gastric inhibitory polypeptide analogues … -
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,
, 
, 
, Revision: 6, Authorised, Last updated: 14/03/2023
Connective and Soft Tissue Gastrointestinal Neoplasms Digestive System … Neoplasms Digestive System Diseases Gastrointestinal Diseases Neoplasms Cancer Gastrointestinal Stromal Tumors … cancer medicine used to treat gastrointestinal stromal tumour (GIST), a … -
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Human medicine European public assessment report (EPAR): Entyvio (updated)
vedolizumab, Colitis, Ulcerative; Crohn Disease
Date of authorisation: 22/05/2014, Revision: 23, Authorised, Last updated: 01/03/2023Digestive System Diseases Gastrointestinal Diseases Gastroenteritis Inflammatory Bowel Diseases Colitis Digestive … Diseases Colitis Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Colonic … -
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Human medicine European public assessment report (EPAR): Pantozol Control
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 11/06/2009, Revision: 16, Authorised, Last updated: 24/05/2022Control Digestive System Diseases Gastrointestinal Diseases Esophageal Diseases Deglutition … Disorders Esophageal Motility Disorders Gastroesophageal Reflux … pantoprazole. It is available as gastroresistant tablets (20 mg). ‘ Gastroresistant’ means that the tablet’s … -
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Human medicine European public assessment report (EPAR): Somac Control
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 12/06/2009, Revision: 15, Authorised, Last updated: 24/05/2022Control Digestive System Diseases Gastrointestinal Diseases Esophageal Diseases Deglutition … Disorders Esophageal Motility Disorders Gastroesophageal Reflux … pantoprazole. It is available as gastroresistant tablets (20 mg). ‘ Gastroresistant’ means that the tablet’s … -
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Human medicine European public assessment report (EPAR): Controloc Control
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 11/06/2009, Revision: 14, Authorised, Last updated: 24/05/2022Control Digestive System Diseases Gastrointestinal Diseases Esophageal Diseases Deglutition … Disorders Esophageal Motility Disorders Gastroesophageal Reflux … pantoprazole. It is available as gastroresistant tablets (20 mg). ‘ Gastroresistant’ means that the tablet’s … -
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Human medicine European public assessment report (EPAR): Teysuno
tegafur, gimeracil, oteracil, Stomach Neoplasms
Date of authorisation: 14/03/2011, Revision: 21, Authorised, Last updated: 04/04/2022Teysuno Cancer Neoplasms Gastrointestinal Neoplasms Digestive System … Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Digestive System … is used to treat advanced gastric (stomach) cancer together … -
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Human medicine European public assessment report (EPAR): Nexium Control
esomeprazole, Gastroesophageal Reflux
Date of authorisation: 26/08/2013, Revision: 16, Authorised, Last updated: 13/01/2022Control Digestive System Diseases Gastrointestinal Diseases Esophageal Diseases Deglutition … Disorders Esophageal Motility Disorders Gastroesophageal Reflux … tablets (20 mg) which are gastroresistant (the contents pass through … -
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Human medicine European public assessment report (EPAR): Pantoloc Control
pantoprazole, Gastroesophageal Reflux
Date of authorisation: 11/06/2009, Revision: 18, Withdrawn, Last updated: 18/01/2022Control Digestive System Diseases Gastrointestinal Diseases Esophageal Diseases Deglutition … Disorders Esophageal Motility Disorders Gastroesophageal Reflux … pantoprazole. It is available as gastroresistant tablets (20 mg). ‘ Gastroresistant’ means that the tablet’s … -
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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): 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 … facts Fasenra benralizumab Gastroentology-HepatologyP/0388/2021EMEA-001214-PIP05-19 Solution for injection Solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): cholic acid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: Cholic acid, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral formulation
Decision date: 31/08/2011, Last updated: 03/10/2011, Compliance check: XCholic acid Gastroentology-Hepatology … Key facts cholic acid Gastroentology-HepatologyP/206/2011Cholic acid Capsule, hard Age-appropriate …