2064 results
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ICH Q4B Annex 8 Sterility test
Last updated: 01/06/2009ICH Q4B Annex 8 Sterility test … of the Q4B process for the Sterility Test General Chapter. The … recognition of pharmacopoeial sterility testing procedures by regulatory …
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Sterilisation of the medicinal product, active substance, excipient and primary container
Last updated: 08/03/2019Sterilisation of the medicinal product … of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition … Draft guideline on the sterilisation of the medicinal product …
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Press release: European Medicines Agency gives recommendations to deal with sterility assurance concerns for DepoCyte
CHMP, Last updated: 24/08/2012recommendations to deal with sterility assurance concerns for DepoCy … deficiencies which could affect the sterility of DepoCyte (cytarabine … relate to a lack of adequate sterility assurance in the manufacturing … -
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ICH Q4B Annex 4A Microbiological examination of non-sterile products: microbial enumeration tests
Last updated: 01/06/2009Microbiological examination of non-sterile products: microbial enumeration … Microbiological Examination of Non-Sterile Products: Microbial Enumeration … Microbiological Examination of Non-Sterile Products: Microbial Enumeration …
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ICH Q4B Annex 4B Test for microbiological examination of non-sterile products: tests for specified microorganisms
Last updated: 01/12/2008microbiological examination of non-sterile products: tests for specified … Microbiological Examination of Non-Sterile Products: Tests for Specified … Microbiological Examination of Non-Sterile Products: Tests for Specified …
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Maximum shelf-life for sterile products for human use after first opening or following reconstitution
Last updated: 28/01/1998Maximum shelf-life for sterile products for human use after … on maximum shelf-life for sterile products for human use after … labels). It applies to all sterile products for human use, with …
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Maximum shelf-life for sterile medicinal products after first opening or following reconstitution
Last updated: 01/07/2000Maximum shelf-life for sterile medicinal products after … Shelf-life, sterile products, stability, opening …
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News: Launch of international pilot programme on inspection of manufacturers of sterile medicines
Last updated: 17/12/2019inspection of manufacturers of sterile medicines … inspection of manufacturers of sterile medicines for human use … inspections of manufacturers of sterile medicines who are located … -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021alpha-1-proteinase inhibitor): Sterility issue with the infusion device … alpha-1-proteinase inhibitor): Sterility issue with the infusion device … alpha-1-proteinase inhibitor): Sterility issue with the infusion … -
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Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020Essential to administer through sterile 0.2 micron or 0.22 micron … Essential to administer through sterile 0.2 micron or 0.22 micron … -
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Stem cell-based products for veterinary use: specific questions on sterility to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
Last updated: 28/06/2019use: specific questions on sterility to be addressed by the Ad … use: specific questions on sterility - Revision 1 PDF icon application/pdf … PDF icon application/pdf sterility_of_stem_cell-based_products_-_qa_en.pdf Adopted 28/06/2019 EMA/CVMP/ADVENT/751229/2016-Rev.1 …
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ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use
Last updated: 01/12/2008microbiological examination of non-sterile products: acceptance criteria … Microbiological Examination of Non-Sterile Products: Acceptance Criteria … microbiological examination of non-sterile products by regulatory authorities …
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Human medicine European public assessment report (EPAR): Dropcys
mercaptamine, Corneal Diseases; Cystinosis
Date of refusal: 24/06/2016,
, Refused, Last updated: 25/07/2016
children, and how stable and sterile the solution would be once … and long-term safety and sterility of the medicine. Thus, the … children, and how stable and sterile the solution would be once … -
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,
, Revision: 13, Authorised, Last updated: 25/03/2022
through a catheter (a thin sterile tube) over 3 to 5 seconds … -
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Human medicine European public assessment report (EPAR): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,
, , Revision: 10, Authorised, Last updated: 10/01/2022
Essential to administer through sterile 0.2 micron or 0.22 micron … -
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Human medicine European public assessment report (EPAR): Respreeza
Human alpha1-proteinase inhibitor, Genetic Diseases, Inborn; Lung Diseases
Date of authorisation: 20/08/2015,, Revision: 10, Authorised, Last updated: 08/12/2021
alpha-1-proteinase inhibitor): Sterility issue with the infusion device … -
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Human medicine European public assessment report (EPAR): Jetrea
ocriplasmin, Retinal Diseases
Date of authorisation: 13/03/2013, Revision: 15, Authorised, Last updated: 16/01/2021should be carried out under sterile conditions. The recommended … should be carried out under sterile conditions. The recommended … should be carried out under sterile conditions. The recommended … -
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Human medicine European public assessment report (EPAR): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 01/03/2022
through a catheter (a thin sterile tube). At least 72 hours … -
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Human medicine European public assessment report (EPAR): Bortezomib Sun
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 09/09/2021
through a catheter (a thin sterile tube). At least 72 hours … -
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 5, Authorised, Last updated: 01/09/2021
through a catheter (a thin sterile tube). When injected under … -
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News: First ever guidance for stem cell therapies in animals published
CVMP, Last updated: 23/06/2017Document gives advice on sterile manufacturing processes for … use: specific questions on sterility 15 June 2017 EMA/CVMP/ADVENT/751229/2016 … use: specific questions on sterility Draft problem statement … -
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ICH: quality
Last updated: 01/04/2022Microbiological examination of non-sterile products: microbial enumeration … microbiological examination of non-sterile products: tests for specified … microbiological examination of non-sterile products: acceptance criteria …
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Quality: specifications, analytical procedures and analytical validation
Last updated: 21/04/2016Microbiological examination of non-sterile products: microbial enumeration … microbiological examination of non-sterile products: tests for specified … microbiological examination of non-sterile products: acceptance criteria …
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ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
Last updated: 01/11/2007Microbiological examination of non-sterile products: microbial enumeration … microbiological examination of non-sterile products: tests for specified … microbiological examination of non-sterile products: acceptance criteria …
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Human medicine European public assessment report (EPAR): Eylea
aflibercept, Wet Macular Degeneration; Macular Edema; Diabetes Complications
Date of authorisation: 21/11/2012, Revision: 26, Authorised, Last updated: 22/03/2022should be carried out under sterile conditions. The pre-filled …