5676 results
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Referral: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 06/03/2014Hydroxyethyl starch solutions for infusion … EMA/809470/2013 Hydroxyethyl-starch solutions (HES) no longer to be used … which concluded that HES solutions must no longer be used to … -
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Referral: Closamectin Pour-on Solution and associated names
ivermectin, closantel, Article 78
Status: European Commission final decision, opinion/position date: 08/10/2015, EC decision date: 22/03/2016, Last updated: 31/05/2016Closamectin Pour-on Solution and associated names … safety of Closamectin Pour-On Solution and associated names. The … benefits of Closamectin Pour-On Solution and associated names continue … -
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Referral: Resflor solution injectable and associated names
florfenicol, flunixin, Article 13
Status: European Commission final decision, opinion/position date: 07/10/2014, EC decision date: 05/12/2014, Last updated: 09/01/2015Resflor solution injectable and associated … decision Overview Resflor is a solution for injection for use in … authorisations for Resflor solution injectable and its associated … -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/202020 mg/mL concentrate for solution for infusion: Risk of medication … concentrate and solvent for solution for infusion Prostatic Neoplasms … 20 mg/mL concentrate for solution for infusion: Risk of medication … -
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News: Benefits of ifosfamide solutions continue to outweigh risks EMA’s safety committee (PRAC) has concluded that the benefits of ifosfamide solutions for infusion
PRAC, Last updated: 12/03/2021Benefits of ifosfamide solutions continue to outweigh risks … the benefits of ifosfamide solutions for infusion … the benefits of ifosfamide solutions for infusion continue to … -
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Referral: Norbonex 5 mg/ml pour-on solution for beef and dairy cattle
eprinomectin, Article 33
Status: European Commission final decision, opinion/position date: 15/01/2014, EC decision date: 21/03/2014, Last updated: 14/05/2014Norbonex 5 mg/ml pour-on solution for beef and dairy cattle … Norbonex 5 mg/ml pour-on solution for beef and dairy cattle … Norbonex 5 mg/ml Pour-on solution for beef and dairy cattle … -
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Referral: Cobactan IV 4.5% powder and solvent for solution for injection and its associated names
cefquinome, associated names: Cobactan, Cobactan Vet., Cobactan 4.5%, Cobactan IV IM 4.5%, Cobactan IV 4.5% A.U.V., Cephaguard IV IM 4.5%, Article 33
Status: European Commission final decision, opinion/position date: 17/05/2006, EC decision date: 21/08/2006, Last updated: 12/08/20144.5% powder and solvent for solution for injection and its associated … a powder and solvent for solution for injection. Cobactan IV … 4.5% powder and solvent for solution for injection and its associated … -
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Referral: Suifertil 4-mg/ml oral solution for pigs and associated names
altrenogest, associated names: Synchroplan, Article 33
Status: European Commission final decision, opinion/position date: 18/07/2013, EC decision date: 02/10/2013, Last updated: 30/10/2013Suifertil 4-mg/ml oral solution for pigs and associated names … Overview Suifertil 4-mg/ml oral solution for pigs contains altrenogest … for Suifertil 4-mg/ml oral solution for pigs and associated names … -
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Referral: Fibrinogen-containing solutions for sealant authorised for administration by spray application
fibrin, associated names: Tisseel, Tissucol, Artiss, Beriplast P, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2012, EC decision date: 15/03/2013, Last updated: 02/04/2013Fibrinogen-containing solutions for sealant authorised for … They are composed of two solutions, one containing fibrinogen … clotting process. When the two solutions are mixed together, thrombin … -
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Referral: Fibrinogen-containing solutions for sealant authorised for administration by spray application
fibrin, associated names: Quixil, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2012, EC decision date: 13/02/2013, Last updated: 02/04/2013Fibrinogen-containing solutions for sealant authorised for … They are composed of two solutions, one containing fibrinogen … clotting process. When the two solutions are mixed together, thrombin … -
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Direct healthcare professional communication (DHPC): GLOBAL RECALL: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion
Active substance: Ceftolozane, tazobactam, DHPC type: Quality defect, Last updated: 22/12/2020powder for concentrate for solution for infusion Bacterial Infec … powder for concentrate for solution for infusion … powder for concentrate for solution for infusion Dear … -
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Referral: Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep
tylosin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 20/06/2019, EC decision date: 20/09/2019, Last updated: 19/11/2019containing tylosin presented as solution for injection to be administered … -
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Referral: Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof
azaperone, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2020, EC decision date: 12/10/2020, Last updated: 30/10/2020Stresnil 40 mg/ml solution for injection for pigs and … -
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Core summary for product characteristics for human albumin solution
Last updated: 13/08/2018characteristics for human albumin solution … containing human albumin solution. …
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Press release: European Medicines Agency finalises review of Baxter's dialysis solutions
CHMP, Last updated: 23/09/2011review of Baxter's dialysis solutions … review of Baxter's dialysis solutions … review of Baxter’s dialysis solutions 7 Westferry Circus … -
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Pharmacovigilance assessments: challenges and solutions for pharmacovigilance assessors
European Medicines Agency, Amsterdam, The Netherlands, from 11/11/2019 to 12/11/2019, Last updated: 03/10/2019assessments: challenges and solutions for pharmacovigilance assessors … assessments and its challenges and solutions; the safe use of medicines … -
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Referral: Veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs
gentamicin, Article 35
Status: European Commission final decision, opinion/position date: 10/11/2016, EC decision date: 27/02/2017, Last updated: 21/04/2017containing gentamicin presented as solutions for injection to be administered … containing gentamicin presented as solutions for injection to be administered … containing gentamicin presented as solutions for injection to be administered … -
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Direct healthcare professional communication (DHPC): RoActemra (tocilizumab): Temporary supply shortage for 162 mg solution for subcutaneous injection and RoActemra 20 mg/mL concentrate for solution for infusion (IV) & recommendations to manage potential risk of disease flare in patient
Active substance: tocilizumab, DHPC type: Medicine shortage, Last updated: 02/09/2021supply shortage for 162 mg solution for subcutaneous injection … 20 mg/mL concentrate for solution for infusion (IV) & recommendations … supply shortage for 162 mg solution for subcutaneous injection … -
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Referral: Veterinary medicinal products containing tylosin base (as a single active substance) presented as solutions for injection for intramuscular use in pigs
tylosin, Article 35
Status: European Commission final decision, opinion/position date: 05/12/2019, EC decision date: 17/04/2020, Last updated: 13/05/2020active substance) presented as solutions for injection for intramuscular … -
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Referral: Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof
dinoprost, Article 35
Status: European Commission final decision, opinion/position date: 18/06/2020, EC decision date: 16/09/2020, Last updated: 06/10/2020lytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated … -
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Press release: Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation
CMDh, Last updated: 26/01/2018Hydroxyethyl-starch solutions for infusion to be suspended … hydroxyethyl-starch (HES) solutions for infusion across the European … sufficient. The review of HES solutions for infusion has been carried … -
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Press release: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
PRAC, Last updated: 12/01/2018suspending hydroxyethyl-starch solutions for infusion from the market … suspending hydroxyethyl-starch solutions for infusion from the market … suspending hydroxyethyl-starch solutions for infusion from the market … -
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Press release: CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone
CMDh, Last updated: 24/07/2014suspension of methadone oral solutions containing high molecular … methadone oral (by mouth) solutions containing high molecular … suspension of methadone oral solutions containing povidone K90 from … -
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Press release: PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl starch
PRAC, Last updated: 14/06/2013authorisations for infusion solutions containing hydroxyethyl starc … the benefits of infusion solutions containing hydroxyethyl starch … medicines be suspended. Infusion solutions containing HES are medicines … -
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Pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)
Last updated: 20/03/2012containing active substances solubilised in micellar systems (non-polymeric … containing active substances solubilised in micellar systems … containing active substances solubilised in micellar systems …