20164 results
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Human medicine European public assessment report (EPAR): Edarbi
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011, Revision: 10, Authorised, Last updated: 17/03/2022Authorised azilsartan medoxomil Overview This is a summary … explains how the Committee for Medicinal Products for Human Use (CHMP … Human Use (CHMP) assessed the medicine to reach its opinion in favour … -
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Human medicine European public assessment report (EPAR): Ipreziv
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011,
, Revision: 4, Withdrawn, Last updated: 19/12/2014
Withdrawn azilsartan medoxomil Overview The marketing authorisation … gt;IprezivEMEA/H/C/002517Azilsartan medoxomilazilsartan medoxomilHypertensionC09CA09 This medicine is under additional monitoring … www.ema.europa.eu/contact © European Medicines Agency, 2014. Reproduction … -
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Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000237-PIP01-08-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules for oral suspension
Decision date: 03/12/2021, Last updated: 16/02/2023, Compliance check: XActive substance Azilsartan medoxomil Therapeutic area Cardiovascular … EMA/626319/2021 European Medicines Agency decision P/0530/2021 … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M10 … -
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Veterinary medicine European public assessment report (EPAR): Zenalpha
medetomidine hydrochloride, vatinoxan hydrochloride, Dogs
Date of authorisation: 15/12/2021, Authorised, Last updated: 15/03/2022Authorised medetomidine hydrochloridevatinoxan hydrochloride … hydrochloride Overview Zenalpha is a medicine used to sedate (calm down … responsible for the activity of a medicine. active substances … -
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Withdrawn application: Isomarv medium
insulin human, date of withdrawal: 15/11/2012, Initial authorisation, Last updated: 14/12/2012Isomarv medium: Withdrawn application … Topics: Medicines … European Union © European Medicines Agency, 2012. Reproduction … -
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Herbal medicinal product: Bursae pastoris herba
Capsella bursa-pastoris (L.) Medik., Shepherds Purse, F: Assessment finalised, Last updated: 23/08/2019questions relating to herbal medicines. Abbreviated as HMPC. More … under 'Committee on Herbal Medicinal Products (HMPC)'. Committee … HMPC)'. Committee on Herbal Medicinal Products ( Committee on Herbal … -
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Human medicine European public assessment report (EPAR): Fluenz Tetra
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human
Date of authorisation: 04/12/2013, Revision: 23, Authorised, Last updated: 09/02/2023Authorised This medicine is authorised for use in … www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction … the Agency assessed the medicine to recommend its authorisation … -
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,
, Revision: 13, Authorised, Last updated: 31/03/2023
Capecitabine Medac Cancer Neoplasms Intestinal … Capecitabine Medac … www.ema.europa.eu © European Medicines Agency, 2012. Reproduction … -
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Human medicine European public assessment report (EPAR): Leflunomide medac
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 18, Authorised, Last updated: 09/03/2023
Leflunomide medac Musculoskeletal Diseases Joint … describing the evaluation of a medicine authorised via the centralised … published on the European Medicines Agency website. European … -
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Human medicine European public assessment report (EPAR): Pemetrexed medac
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,, Revision: 8, Authorised, Last updated: 09/08/2022
Pemetrexed medac Cancer Neoplasms Carcinoma … Pemetrexed medac … www.ema.europa.eu © European Medicines Agency, 2012. Reproduction … -
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Human medicine European public assessment report (EPAR): Imatinib medac
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome
Date of authorisation: 25/09/2013,, Revision: 5, Withdrawn, Last updated: 16/10/2019
Imatinib medac Precursor Cell Lymphoblastic … The approval to market a medicine in one, several or all European … authorisation for Imatinib Medac has been withdrawn at the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera), Ceftobiprole medocaril (sodium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000205-PIP02-11-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 03/12/2021, Last updated: 25/06/2021, Compliance check: Xassociated names Ceftobiprole medocaril (sodium) Infectious diseasesP/0529/2021EMEA-000205-PIP02-11-M05 … International Ltd E-mail: medical.information@basilea.com Tel. +41 6160 61400 PM: decision … investigation plan for ceftobiprole medocaril (sodium), (Zevtera and associated … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide medac
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Revision: 2, Authorised, Last updated: 26/04/2022
Arsenic trioxide medac Cancer Neoplasms Leukemia … Arsenic trioxide medac … www.ema.europa.eu © European Medicines Agency, 2012. Reproduction … -
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Veterinary medicine European public assessment report (EPAR): Medicinal Oxygen Air Liquide Sante
oxygen, Horses; Dogs; Cats
Date of authorisation: 20/12/2006, Withdrawn, Last updated: 21/09/2010Medicinal Oxygen Air Liquide Sante … marketing authorisation for Medicinal Oxygen Air Liquide Santé … holder. Summary documents Medicinal Oxygen Air Liquide Sante … -
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Human medicine European public assessment report (EPAR): Milnacipran Pierre Fabre Medicament
milnacipran, Fibromyalgia
Date of refusal: 08/04/2010, Refused, Last updated: 26/04/2010Milnacipran Pierre Fabre Medicament Fibromyalgia … July 2009, the Committee for Medicinal Products for Human Use (CHMP … marketing authorisation for the medicinal product Milnacipran Pierre … -
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Human medicine European public assessment report (EPAR): Zeftera (previously Zevtera)
ceftobiprole medocaril, Skin Diseases, Infectious; Soft Tissue Infections
Date of refusal: 16/09/2010, Refused, Last updated: 22/09/2010February 2010, the Committee for Medicinal Products for Human Use (CHMP … marketing authorisation for the medicinal product Zeftera, intended … previously Zevtera)ceftobiprole medocarilceftobiproleSkin Diseases, InfectiousSoft … -
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Referral: Alpha2-adrenoreceptor agonists
Xylazine, medetomidine, detomidine, romifidine, Article 78
Status: European Commission final decision, opinion/position date: 12/11/2008, EC decision date: 30/04/2009, Last updated: 22/06/2009provided by Committee for Medicinal Products for Human Use CMDh … relaxation. Xylazine, detomidine, medetomidine and romifidine are alpha2-adrenoreceptor … Beoordeling van Geneesmiddelen (Medicines Evaluation Board, The Netherlands … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001914-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Olmesartan medoxomil rosuvastatin calcium Cardiovascular … specific waiver for olmesartan (medoxomil) / rosuvastatin (calcium … European Medicines Agency decision P/0166/2016 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001852-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/11/2015, Last updated: 07/01/2016, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … European Medicines Agency decision P/0293/2015 … specific waiver for olmesartan medoxomil / amlodipine (besilate) (EMEA-001852-PIP01-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001538-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … besilate) / olmesartan (medoxomil) (EMEA-001538-PIP01-13) PDF … European Medicines Agency decision P/0320/2013 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ceftobiprole medocaril (sodium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000205-PIP01-08-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 29/04/2013, Last updated: 31/05/2013, Compliance check: XKey facts Ceftobiprole medocaril (sodium) Infectious diseasesP/0087/2013EMEA-000205-PIP01-08-M02 … International Ltd E-mail: medical.information@basilea.com Country: Switzerland Tel … investigation plan for ceftobiprole medocaril (sodium) (EMEA-000205-PIP01-08-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Azilsartan medoxomil, chlortalidone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001294-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/10/2012, Last updated: 27/11/2012, Compliance check: XKey facts Azilsartan medoxomil chlortalidone Cardiovascular … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294 … European Medicines Agency decision P/0224/2012 … -
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Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
Zoledronic acid medac Wounds and Injuries Cancer Neoplasms Fractures … Zoledronic acid medac … www.ema.europa.eu © European Medicines Agency, 2012. Reproduction … -
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Orphan designation: Adenovirus-mediated herpes-simplex-virus thymidine-kinase (HKSV-tk) gene for: Treatment of high-grade glioma with subsequent use of ganciclovir sodium
Date of designation: 06/02/2002, Positive, Last updated: 16/09/2021Adenovirus-mediated herpes-simplex-virus thymidine-kinase … orphan designation Adenovirus-mediated Herpes simplex virus – … Rev.4 Committee for Orphan Medicinal Products Public summary … -
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Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,, 
, Revision: 9, Authorised, Last updated: 06/10/2022
Pandemic influenza vaccine H5N1 Medimmune) Respiratory Tract Diseases Respiratory … describing the evaluation of a medicine authorised via the centralised … published on the European Medicines Agency website. European …