181 results
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Press release: New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines
CMDh, Last updated: 27/03/2015medicines are authorised, according to an agreed timetable. In … medicines are authorised, according to an agreed timetable … measures will now be implemented according to an agreed timetable in … -
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Press release: Numeta G13%E to be suspended and new risk-minimisation measures to be introduced for Numeta G16%E
CMDh, Last updated: 20/09/2013appropriate intervals thereafter in accordance with routine clinical practice … information should be revised accordingly and healthcare professionals … directly in all Member States, according to an agreed timetable … -
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News: Committee for paediatric medicinal products - towards more and better information on the use of medicines for children
PDCO, Last updated: 18/02/2013medicine for children in accordance with the requirements of … formulated and investigated according to their specific needs … EMA/PDCO/388684/2012 Page 2/6 According to Art. 25(2) of the Universal … -
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Press release: CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections
CMDh, Last updated: 01/04/2016medicines in their territories, according to an agreed timetable … medicines in their territories, according to an agreed timetable. Information … medicines are authorised, according to an agreed timetable … -
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Press release: Codeine not to be used in children below 12 years for cough and cold
CMDh, Last updated: 24/04/2015medicines are authorised, according to an agreed timetable … medicines are authorised, according to an agreed timetable … medicines are authorised, according to an agreed timetable. Contact … -
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Press release: CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone
CMDh, Last updated: 24/07/2014these medicines are marketed, according to an agreed timetable … these medicines are marketed, according to an agreed timetable. Information … medicines are authorised according to an agreed timetable … -
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Press release: Updated advice on use of high-dose ibuprofen
CMDh, Last updated: 22/05/2015medicines are authorised, according to an agreed timetable … medicines are authorised, according to an agreed timetable. Information … anti- inflammatory drug use according to time passed after first-time … -
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Press release: Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
CMDh, Last updated: 29/06/2018safety of HES prescribed according to the recommendations for … and should be considered according to relevant clinical guidelines … safety of HES prescribed according to the recommendations for … -
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News: General Court upholds European Medicines Agency decision to refuse paediatric waiver for perflubutane
PDCO, Last updated: 15/12/2011perflubutane EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … EMEA-000194-PIP01-08 in accordance with Regulation (EC) No 1901/2006 … -
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Press release: New Paediatric Committee holds its first meeting
PDCO, Last updated: 06/07/2007data have been generated in accordance with an agreed paediatric … data have been generated in accordance with an agreed paediatric … -
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Press release: CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls
CMDh, Last updated: 21/11/2014implemented by EU Member States according to an agreed timetable … implemented by EU Member States according to an agreed timetable … -
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Press release: Restrictions on use of codeine for pain relief in children – CMDh endorses PRAC recommendation
CMDh, Last updated: 28/06/2013directly by all Member States, according to an agreed timetable … directly by all Member States, according to an agreed timetable. Information … metabolisers, but prevalence differs according to racial and ethnic group … -
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Press release: Withdrawal of pain medicine flupirtine endorsed
CMDh, Last updated: 23/03/2018medicines are authorised, according to an agreed timetable. 1 … medicines are authorised, according to an agreed timetable … -
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News: EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 04/10/2021studied for use in children, in accordance with the accelerated timelines … -
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News: EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19
CHMP, PDCO, PRAC, Last updated: 18/11/2021studied for use in children, in accordance with the accelerated timelines … -
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Press release: Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation
CMDh, Last updated: 26/01/2018dextrans) and should be selected according to relevant clinical guidelines … dextrans) and should be selected according to relevant clinical guidelines … -
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Press release: CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins
CMDh, Last updated: 01/08/2017medicines are authorised, according to an agreed timetable. 1 … -
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Press release: Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations
CMDh, Last updated: 25/10/2013in their territories. In accordance with EU legislation, this … in their territories. In accordance with EU legislation, this … -
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Press release: Restrictions on use of short-acting beta-agonists in obstetric indications – CMDh endorses PRAC recommendations
CMDh, Last updated: 25/10/2013directly in all Member States, according to an agreed timetable. Healthcare … directly in all Member States, according to an agreed timetable. Healthcare … -
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Press release: Oral almitrine to be withdrawn by EU Member States
CMDh, Last updated: 31/05/2013almitrine is authorised, according to an agreed timetable, which … almitrine is authorised, according to an agreed timetable which … -
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News: EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19
CHMP, PDCO, PRAC, Last updated: 11/10/2021studied for use in children, in accordance with the accelerated timelines … -
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Press release: Modified-release paracetamol-containing products to be suspended from EU market
CMDh, Last updated: 15/12/2017preparations when used in accordance with their product information … preparations when used in accordance with their product information … -
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Press release: No consistent evidence of an increased risk of heart problems with testosterone medicines
CMDh, Last updated: 21/11/2014now be directly implemented according to an agreed timetable by … be directly implemented according to an agreed timetable by … -
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Press release: CMDh endorses restricted use of bromocriptine for stopping breast milk production
CMDh, Last updated: 21/08/2014medicines will be updated accordingly once a final legally binding … medicines will be updated accordingly once a final legally binding … -
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Paediatric Committee (PDCO): 20-23 July 2021
Virtual meeting, from 20/07/2021 to 23/07/2021, Last updated: 15/12/2021and safety information In accordance with the Agency’s health … adopted or considered public according to the principles stated …