13100 results
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012, Revision: 14, Authorised, Last updated: 15/12/2022previously Mercaptopurine Nova Laboratories) Cancer Leukemia Neoplasms Lymphoproliferative … previously Mercaptopurine Nova Laboratories) … authorisation) Mercaptopurine Nova Laboratories mercaptopurine On 21 July … -
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Herbal medicinal product: Melaleucae aetheroleum
Melaleuca alternifolia (Maiden and Betche) Cheel, Tea-tree oil, F: Assessment finalised, Last updated: 15/03/2022branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … Tea tree oil Melaleuca alternifolia (Maiden and Betch) Cheel … branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … -
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Orphan designation: losartan for: Treatment of epidermolysis bullosa
Date of designation: 26/02/2019, Positive, Last updated: 07/03/2022formation of scars on the skin. Losartan is expected to block the … medicine? The effects of losartan have been evaluated in experimental … volunteers. clinical trial with losartan in patients with epidermolysis … -
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Orphan designation: losartan for: Treatment of osteogenesis imperfecta
Date of designation: 21/06/2022, Positive, Last updated: 15/09/2022there are no satisfactory alternative methods for the diagnosis … facts straight Key facts losartanTreatment of osteogenesis imperfectaPositiveEU/3/22/2622 … 14 2.2.3. losartan - EMA/OD/0000075685 … -
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Referral: Cozaar
losartan, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/04/2008, EC decision date: 03/09/2008, Last updated: 25/09/2008II) receptor antagonist, losartan, acting on the AT1 receptor … angiotensin system (RAS) cascade. Losartan is indicated for the treatment … treatment of hypertension. Losartan may also delay progression … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, losartan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001380-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/02/2013, Last updated: 23/04/2013, Compliance check: XKey facts amlodipine losartan Cardiovascular diseasesP/0040/2013EMEA-001380-PIP01-12 … product-specific waiver for amlodipine / losartan (EMEA-001380-PIP01-12) PDF … specific waiver for amlodipine / losartan (EMEA-001380-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000008-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 29/02/2008, Last updated: 19/03/2008, Compliance check: V, 06/02/2009Key facts Losartan potassium Cardiovascular … Cozaar and associated names, losartan potassium EMEA-000008-PIP01-07 … Word - Decision and Opinion losartan 000008-PIP01-07 European … -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium, 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-001390-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/04/2013, Last updated: 31/05/2013, Compliance check: XKey facts Losartan potassium Amlodipine besilate … for amlodipine (besilate) / losartan (potassium) (EMEA-001390-PIP01-12 … for amlodipine (besilate) / losartan (potassium) (EMEA- 001390-PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine camsylate, Losartan potassium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000886-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/09/2010, Last updated: 29/10/2010, Compliance check: Xfacts Amlodipine camsylate Losartan potassium Cardiovascular … for amlodipine camsylate / losartan potassium (EMEA-000886-PIP01-10 … 000886-PIP01-10 Decision Losartan potassium, Amlodipine camsylate 7 … -
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News: Panexcell Clinical Laboratories: suspension of medicines over flawed studies
CHMP, Last updated: 24/07/2020Panexcell Clinical Laboratories: suspension of medicines over … tested by Panexcell Clinical Laboratories Priv. Ltd at its site in … from Panexcell must provide alternative data demonstrating bioequivalence … -
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Clinical efficacy and safety: blood products (including biotech alternatives)
Last updated: 11/02/2016products (including biotech alternatives) …
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Press release: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
Last updated: 19/11/2018Valsartan from Mylan laboratories in India can no longer be … candesartan, irbesartan, losartan and olmesartan. The review … Pharmacopoeia Valsartan from Mylan laboratories in India can no longer be … -
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Good laboratory practice compliance
Last updated: 21/12/2015Good laboratory practice compliance … Good laboratory practice compliance … Human/Veterinary use • GLP Good Laboratory Practice • JAR Joint …
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Press release: European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories
CHMP, Last updated: 16/02/2012manufactured at Ben Venue Laboratories … assurance identified at Ben Venue Laboratories, Ohio, USA, the European Medicines … medicines to remove Ben Venue Laboratories, Ohio as manufacturing site … -
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Press release: Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU
CHMP, Last updated: 24/06/2016Studies from Alkem Laboratories Ltd cannot be used to support … were conducted at the Alkem Laboratories Ltd site in Taloja, India … conduct of studies by Alkem Laboratories Ltd, the studies cannot be … -
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Press release: Alcon Laboratories withdraws its application for RETAANE
Last updated: 02/03/2006Alcon Laboratories withdraws its application … formally notified by Alcon Laboratories (UK) Ltd of its decision … for depot injection. Alcon Laboratories (UK) Ltd submitted an application … -
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Press release: European Medicines Agency recommends precautionary recall of remaining batch of Vistide manufactured at Ben Venue Laboratories
Last updated: 13/12/2011manufactured at Ben Venue Laboratories … GMP) inspection at Ben Venue Laboratories' manufacturing site in Ohio … product shortage since an alternative manufacturer of Vistide is … -
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Promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU - Scientific guideline
Last updated: 26/07/2021omoting the authorisation of alternatives to antimicrobial veterinary … omoting the authorisation of alternatives to antimicrobial veterinary … promoting the authorisation of alternatives to antimicrobial veterinary …
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Emerging medicinal products: from laboratory to patient use
London, UK, 14/12/2015, Last updated: 13/11/2015medicinal products: from laboratory to patient use … Medicinal Products – from laboratory to patient use”. This conference … medicinal products: from laboratory to patient use PDF icon application/pdf … -
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Press release: Fournier Laboratories withdraws its marketing authorisation application for Synordia
Last updated: 08/12/2006Fournier Laboratories withdraws its marketing authorisation … formally notified by Fournier Laboratories Ireland Ltd of their decision … PRESS RELEASE Fournier Laboratories withdraws its marketing authorisation … -
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Press release: European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories
CHMP, Last updated: 22/11/2011quality assurance at Ben Venue Laboratories … inspection at the Ben Venue Laboratories manufacturing site in Ohio … Venue no longer essential, as alternative manufacturers are currently … -
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Press release: Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels
CMDh, Last updated: 20/12/2013be used as additional or alternative treatment to reduce high … only as an additional or alternative treatment in type IIb and … role as an additional or alternative treatment to reduce triglycerides … -
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Press release: PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels
PRAC, Last updated: 08/11/2013acipimox only as additional or alternative treatment to lower high triglyceride … acipimox only as additional or alternative treatment to lower high triglyceride … acipimox only as additional or alternative treatment to lower high triglyceride … -
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Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products - Scientific guideline
Last updated: 23/04/2009rabbit pyrogen testing by an alternative test for plasma derived medicinal … rabbit pyrogen testing by an alternative test for plasma derived medicinal … RABBIT PYROGEN TESTING BY AN ALTERNATIVE TEST FOR PLASMA DERIVED MEDICINAL …
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Press release: European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories
Last updated: 09/12/2011quality assurance at Ben Venue Laboratories … GMP) inspection at Ben Venue Laboratories' manufacturing site in Ohio … meet clinical needs, whether alternative treatment options were available …