340 results
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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: Pharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped due to manufacturing failings
CHMP, Last updated: 16/09/2016still be supplied where no alternatives are available … still be supplied where no alternatives are available The European … where there are no treatment alternatives. In EU countries where treatment … -
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Press release: European Medicines Agency gives recommendations to deal with sterility assurance concerns for DepoCyte
CHMP, Last updated: 24/08/2012patients who have no suitable alternatives. At present, there is no evidence … countries where suitable alternative treatments are available … on DepoCyte and for whom alternative treatments are not appropriate … -
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Press release: Update on the withdrawal of Thelin
CHMP, Last updated: 16/12/2010Prescribers should choose alternatives in line with treatment guidel … Prescribers should choose alternatives in line with treatment guidelines … Committee has also considered alternative treatment options. The … -
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Press release: European Medicines Agency updates treatment recommendations because of continued Fabrazyme shortage
CHMP, Last updated: 06/07/2010consider switching patients to alternative treatment … consider switching patients to alternative treatment The European … that in situations where alternative treatment is available, no … -
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Press release: European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole
CHMP, Last updated: 26/07/2013doctor to discuss suitable alternative treatments. Doctors should … of the currently available alternative treatments, which are deemed … meet current standards, and alternative treatments are available … -
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Press release: Suspension of ranitidine medicines in the EU
CHMP, Last updated: 30/04/2020heartburn and stomach ulcers. Alternatives are available and patients … -
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Press release: EMA recommends suspension of medicines over flawed studies at Semler Research Centre
CHMP, Last updated: 22/07/2016bioequivalence is demonstrated using alternative data. Bioequivalence studies … bioequivalence is demonstrated using alternative data. Bioequivalence studies … During the evaluation, alternative studies were provided for … -
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Press release: European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β-amyloid neuritic plaque density
CHMP, Last updated: 19/10/2012include headache and taste alterations. Given the public health burden … disease-modifying agents can alter the long-term course of the … include headache and taste alterations. Given the public health … -
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News: EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep (updated)
CHMP, Last updated: 28/09/2023about possible treatment alternatives. Information for healthcare … -
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Press release: European Medicines Agency recommends restricting Trobalt to last-line therapy in partial epilepsy
CHMP, Last updated: 31/05/2013for patients who cannot use alternatives; restricted use is recommended … patients who cannot use alternatives; restricted use is recommended … Trobalt remains a valuable alternative option for patients whose … -
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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: 16/02/2012in the EU and for which no alternative manufacturer or formulation … authorisations until a suitable alternative manufacturing site is approved … marketing authorisations as alternative suppliers or formulations … -
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Press release: European Medicines Agency agrees to recall of Vimpat 15-mg/ml syrup
CHMP, Last updated: 22/07/2011to switch patients to an alternative formulation whenever possible … to be switched to suitable alternatives. Doctors advised to switch … to switch patients to an alternative formulation possible The … -
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Press release: Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation
CMDh, Last updated: 26/01/2018loss, where treatment with alternative products known as 'crystalloids' … infusion should be suspended. Alternative treatment options are available … loss, where treatment with alternative products known as ‘crystalloids’ … -
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Press release: New measures to avoid valproate exposure in pregnancy endorsed
CMDh, Last updated: 23/03/2018women unless there was no alternative, the evidence shows that this … women unless there was no alternative, the evidence shows that … should never be started unless alternative treatments are not suitable … -
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Press release: EMA recommends additional measures to prevent use of mycophenolate in pregnancy
CHMP, Last updated: 23/10/2015unless there is no suitable alternative to prevent transplant rejecti … unless there is no suitable alternative to prevent transplant rejection … pregnancy unless no suitable alternative is available to prevent transplant … -
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Press release: First stem-cell therapy recommended for approval in EU
CHMP, Last updated: 19/12/2014to patients,' says Enrica Alteri, Head of EMA's Human Medicines … eye(s) after removal of the altered corneal epithelium. It is … culture. Holoclar can offer an alternative to transplantation for replacing … -
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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: 22/11/2011Venue no longer essential, as alternative manufacturers are currently … is terminally sterilised. Alternative manufacturers of Vistide … meet clinical needs, whether alternative treatment options were available … -
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News: Revocation of authorisation for sickle cell disease medicine Adakveo
CHMP, Last updated: 09/08/2023possible opportunity to discuss alternative treatments. If you have any … -
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Press release: Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU
CHMP, Last updated: 24/06/2016refused authorisation, unless alternative data are available from other … Laboratories Ltd. So far no alternative studies from other sources … the market in the EU, as alternative studies have been provided … -
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Press release: EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots
CHMP, Last updated: 15/11/2019unless there is no suitable alternative treatment. Further, EMA is … Xeljanz only when there is no alternative treatment. These recommendations … -
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Press release: EMA recommends avoidance of certain hepatitis C medicines and amiodarone together
CHMP, Last updated: 24/04/2015there is no other suitable alternative. If there is no alternative to giving amiodarone at the … there is no other suitable alternative. … • If there is no alternative to giving amiodarone at the … -
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News: EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
CHMP, Last updated: 13/01/2023if no suitable treatment alternatives are available: those aged … are no suitable treatment alternatives for you. If you have certain … if no suitable treatment alternatives are available: those aged … -
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Press release: Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled
CHMP, Last updated: 25/10/2013from unaffected batches or alternative treatment … from unaffected batches or alternative treatment The European … batches are not available, to alternative treatment. Patients or … -
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Press release: European Medicines Agency recommends transfer of manufacturing sites for Caelyx and Ceplene
CHMP, Last updated: 16/03/2012in Ohio, United States, to alternative facilities. While the transfers … essential for patients and no alternative suppliers or alternative formulations are currently … in Ohio, United States, to alternative facilities. While the transfers …