12709 results
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Pending EC decisions on maximum residue limits
Last updated: 12/03/2010decisions on maximum residue limits … decisions on maximum residue limits …
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Direct healthcare professional communication (DHPC): Visudyne (verteporfin): Information on the continuing supply limitation until end of 2023
Active substance: verteporfin, DHPC type: Medicine shortage, Last updated: 12/08/2022on the continuing supply limitation until end of 2023 Myopia … on the continuing supply limitation until end of 2023 … on the continuing supply limitation until end of 2023 Dear … -
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Press release: Wyeth Europa Limited withdraws its marketing authorisation application for Brilence
Last updated: 28/05/2010Wyeth Europa Limited withdraws its marketing authorisation … notified by Wyeth Europa Limited of its decision to withdraw … 21-24 June 2010. Wyeth Europa Limited withdraws its marketing authorisation … -
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Press release: La Jolla Limited withdraws its marketing authorisation application for Riquent
Last updated: 13/10/2006La Jolla Limited withdraws its marketing authorisation … La Jolla Limited withdraws its marketing authorisation … PRESS RELEASE La Jolla Limited withdraws its marketing authorisation … -
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Press release: Four-week limit for use of high-strength estradiol creams
PRAC, Last updated: 04/10/2019Four-week limit for use of high-strength … committee (PRAC) has recommended limiting the use of high-strength … size of the tube will be limited to 25 grams to prevent use … -
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News: New medicine for multiple myeloma patients with limited treatment options
Last updated: 22/07/2022multiple myeloma patients with limited treatment options … multiple myeloma patients with limited treatment options … -
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CVMP recommendations on limited market classification and eligibility for authorisation under Article 23
Last updated: 17/07/2023CVMP recommendations on limited market classification and … CVMP recommendations on limited market classification and …
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Availability of veterinary medicinal products - extrapolation of maximum residue limits - Scientific guideline
Last updated: 18/06/2018extrapolation of maximum residue limits - Scientific guideline … extrapolation of maximum residue limits - Scientific guideline …
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News: Changes to submission and assessment of maximum residue limits of veterinary medicines in foods
Last updated: 07/06/2018assessment of maximum residue limits of veterinary medicines in … assessment of maximum residue limits (MRLs) of veterinary medicines … use or minor species (MUMS)/limited market will be revised to … -
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Workshop on generation and use of Health Based Exposure Limits (HBEL)
European Medicines Agency, London, UK, from 20/06/2017 to 21/06/2017, Last updated: 04/08/2017of Health Based Exposure Limits (HBEL … of Health-Based Exposure Limits (HBELs) in the context of … of Health Based Exposure Limits (HBEL) PDF icon application/pdf … -
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Risk characterisation and assessment of maximum residue limits (MRL) for biocides - Scientific guideline
Last updated: 30/01/2015assessment of maximum residue limits (MRL) for biocides - Scientific … assessment of maximum residue limits (MRL) for biocides - Scientific … assessment of maximum residue limits (MRL) for biocides Draft …
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News: Policy on veterinary medicines for minor use, minor species / limited market revised
CVMP, Last updated: 16/09/2014minor use, minor species / limited market revised … minor-use-minor-species (MUMS) / limited-market policy for veterinary medicines … classified as intended for MUMS/limited market: reduced data requirements … -
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Press release: European Medicines Agency recommends limiting long-term use of calcitonin medicines
CHMP, Last updated: 20/07/2012Medicines Agency recommends limiting long-term use of calcitonin … Medicines Agency recommends limiting long-term use of calcitonin … Medicines Agency recommends limiting long- term use of calcitonin … -
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Press release: Celgene Europe Limited withdraws its application for an extension of the indication for Revlimid (lenalidomide)
Last updated: 21/06/2012Celgene Europe Limited withdraws its application … Celgene Europe Limited withdraws its application … release Celgene Europe Limited withdraws its application … -
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Press release: RepliGen Europe Limited withdraws its marketing authorisation application for SecreFlo (secretin human)
Last updated: 14/09/2012RepliGen Europe Limited withdraws its marketing authorisation … notified by RepliGen Europe Limited of its decision to withdraw … release RepliGen Europe Limited withdraws its marketing authorisation … -
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Press release: Alkermes Pharma Ireland Limited withdraws its marketing authorisation application for Megestrol Alkermes (megestrol)
Last updated: 13/03/2012Alkermes Pharma Ireland Limited withdraws its marketing authorisation … by Alkermes Pharma Ireland Limited of its decision to withdraw … Alkermes Pharma Ireland Limited withdraws its marketing authorisation … -
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Press release: Pfizer Limited withdraws its application for an extension of the indication for Macugen (pegaptanib sodium)
Last updated: 19/07/2011Pfizer Limited withdraws its application … formally notified by Pfizer Limited of its decision to withdraw … injection. On 14 June 2010, Pfizer Limited submitted an application … -
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Press release: Abbott Laboratories Limited withdraws its marketing authorisation application for Ozespa (briakinumab)
Last updated: 17/01/2011Abbott Laboratories Limited withdraws its marketing authorisation … Abbott Laboratories Limited withdraws its marketing authorisation … release Abbott Laboratories Limited withdraws its marketing authorisation … -
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Press release: Merck Serono Europe Limited withdraws its marketing authorisation application for Movectro (cladribine)
Last updated: 17/02/2011Merck Serono Europe Limited withdraws its marketing authorisation … notified by Merck Serono Europe Limited of its decision to withdraw … release Merck Serono Europe Limited withdraws its marketing authorisation … -
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Press release: Gendux Molecular Limited withdraws its marketing authorisation application for Contusugene ladenovec Gendux (contusugene ladenovec)
Last updated: 23/07/2009Gendux Molecular Limited withdraws its marketing authorisation … Gendux Molecular Limited withdraws its marketing authorisation … RELEASE Gendux Molecular Limited withdraws its marketing authorisation … -
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Press release: Antigenics Therapeutics Limited withdraws its marketing authorisation application for Oncophage (vitespen)
Last updated: 02/12/2009Antigenics Therapeutics Limited withdraws its marketing authorisation … by Antigenics Therapeutics Limited of its decision to withdraw … Antigenics Therapeutics Limited withdraws its marketing authorisation … -
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Press release: Gendux Molecular Limited withdraws its marketing authorisation application for Advexin (contusugene ladenovec)
Last updated: 19/12/2008Gendux Molecular Limited withdraws its marketing authorisation … notified by Gendux Molecular Limited of its decision to withdraw … RELEASE Gendux Molecular Limited withdraws its marketing authorisation … -
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Press release: Celgene Europe Limited withdraws its marketing authorisation application for Lenalidomide Celgene Europe (lenalidomide)
Last updated: 04/06/2008Celgene Europe Limited withdraws its marketing authorisation … notified by Celgene Europe Limited of its decision to withdraw … RELEASE Celgene Europe Limited withdraws its marketing authorisation … -
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Establishment of maximum residue limits for milk considering the daily intake by children - Scientific guideline
Last updated: 01/11/2002blishment of maximum residue limits for milk considering the … blishment of maximum residue limits for milk considering the … multiplies the maximum residue limit for individual drugs by a …
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Establishment of maximum residue limits for Salmonidae and other fin fish - Scientific guideline
Last updated: 01/01/1998blishment of maximum residue limits for Salmonidae and other … blishment of maximum residue limits for Salmonidae and other … ESTABLISHMENT OF MAXIMUM RESIDUE LIMITS FOR SALMONIDAE AND OTHER …