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Press release: CMDh endorses recommendations to restrict the use of diacerein-containing medicines
CMDh, Last updated: 21/03/2014recommendations to restrict the use of diacerein-containing medicines … to limit risks of severe diarrhoea and effects on the liver … recommendations to restrict the use of diacerein-containing medicines Restrictions intended … -
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Press release: New safety advice for diclofenac – CMDh endorses PRAC recommendation
CMDh, Last updated: 28/06/2013New safety advice for diclofenac – CMDh endorses PRAC recomm … majority new safety advice for diclofenac-containing medicines that are given … that the effects of systemic diclofenac on the heart and circulation … -
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Press release: Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC recommendation endorsed by CMDh
CMDh, Last updated: 30/05/2013Benefits of Diane 35 and its generics outweigh … concluded that the benefits of Diane 35 (cyproterone acetate 2 … reproductive age. Furthermore, Diane 35 and generics should only … -
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Press release: New measures to avoid valproate exposure in pregnancy endorsed
CMDh, Last updated: 23/03/2018treat epilepsy and bipolar disorder and in some countries for … medicines for migraine or bipolar disorder during pregnancy, and a ban … medicine each time it is dispensed. The CMDh agreed with EMA's … -
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Press release: New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines
CMDh, Last updated: 27/03/2015include use to treat anxiety disorders, for relief of pruritus (itching … surgery, and treatment of sleep disorders. Recommendations for these … PRAC concluded that the risk did not … -
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Press release: Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels
CMDh, Last updated: 20/12/2013changes in lifestyle, including diet and exercise, and treatment … laropiprant, in treating lipid disorders. The study showed that adding … medicines used to treat lipid disorders) … -
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Press release: Updated advice on use of high-dose ibuprofen
CMDh, Last updated: 22/05/2015including COX-2 inhibitors and diclofenac. No increase in cardiovascular … such as heart failure, heart disease and circulatory problems … smoking, high blood pressure, diabetes and high blood cholesterol … -
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Press release: CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls
CMDh, Last updated: 21/11/2014valproate for epilepsy or bipolar disorder in pregnant women, in women … option for epilepsy or bipolar disorder should be advised on the … talking, memory problems, difficulty with speech and language … -
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Press release: CMDh endorses restricted use of bromocriptine for stopping breast milk production
CMDh, Last updated: 21/08/2014the need to avoid further distress after loss of the baby during … including women with various disorders that increase blood pressure … who have or have had heart disease or severe psychiatric … -
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Press release: Oral almitrine to be withdrawn by EU Member States
CMDh, Last updated: 31/05/2013PRAC recommendation will be directly implemented following CMDh … PRAC recommendation will be directly implemented following CMDh … will now be implemented directly by the Member States where … -
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Press release: Codeine not to be used in children below 12 years for cough and cold
CMDh, Last updated: 24/04/2015effects, such as breathing difficulties. The new measures follow a … consensus, the measures will be directly implemented by the Member … effects, such as breathing difficulties. The new measures follow … -
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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: 01/08/2017muscles causing breathing difficulty) and anaphylaxis (sudden severe … reactions. In this case it may be difficult to determine whether the … muscles causing breathing difficulty) and anaphylaxis (sudden severe … -
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Press release: No consistent evidence of an increased risk of heart problems with testosterone medicines
CMDh, Last updated: 21/11/2014increased risk, while others did not, and some of the studies … consensus and they will now be directly implemented according to … increased risk, while others did not, and some of the studies … -
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Press release: Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh
CMDh, Last updated: 29/04/2013with your treating doctor to discuss your treatment. Your doctor … your treating doctor to discuss your treatment. Your doctor … with tetrazepam are skin disorders, which are sometimes serious … -
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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: 20/09/2013nausea and vomiting, breathing difficulties, hypotension (low blood pressure … magnesium. The PRAC also noted the difficulty in identifying symptoms of … they will now be implemented directly in all Member States, according … -
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Press release: Restrictions on use of codeine for pain relief in children – CMDh endorses PRAC recommendation
CMDh, Last updated: 28/06/2013it will now be implemented directly by all Member States, according … will now be implemented directly by all Member States, according … metabolisers, but prevalence differs according to racial and ethnic … -
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Press release: Modified-release paracetamol-containing products to be suspended from EU market
CMDh, Last updated: 15/12/2017Recommendation endorsed due to the difficulty in managing overdose The … of a longer-acting product did not outweigh the complications … modified-release products, making it difficult to decide how the overdose … -
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Press release: CMDh confirms recommendations on restricting use of domperidone-containing medicines
CMDh, Last updated: 25/04/2014symptoms such as bloating, discomfort and heartburn. The review … symptoms such as bloating, discomfort and heartburn. The review … used for various stomach and digestive problems. There have been … -
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Press release: Restrictions in the use of flupirtine-containing medicines - CMDh endorses PRAC recommendation
CMDh, Last updated: 28/06/2013patients with pre-existing liver disease or alcohol abuse problems … patients with pre-existing liver disease or alcohol abuse problems … results or symptoms of liver disease. • Flupirtine must not … -
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Press release: CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone
CMDh, Last updated: 24/07/2014povidone, which is available in different molecular weights. While … povidone, which is available in different molecular weights. While … Povidone is available in different molecular weights. If methadone … -
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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: 25/10/2013of kidney injury requiring dialysis in critically ill patients … kidney injury requiring dialysis in critically ill patients1,2,3 … therapy. The use of HES must be discontinued at the first sign of renal … -
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Press release: Restrictions on use of short-acting beta-agonists in obstetric indications – CMDh endorses PRAC recommendations
CMDh, Last updated: 25/10/2013they will now be implemented directly in all Member States, according … will now be implemented directly in all Member States, according … women with a history of heart disease or significant risk factors … -
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Press release: Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation
CMDh, Last updated: 26/01/2018practice suggests that it is difficult to clearly distinguish patients who can be administered … practice suggests that it is difficult to clearly distinguish patients who can be administered … Agency, under Article 107i of Directive 2001/83/EC. The review … -
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Press release: Restrictions in use of cyproterone due to meningioma risk
CMDh, Last updated: 27/03/2020and legs. If a patient is diagnosed with meningioma, treatment … consensus and will be implemented directly at national level … -
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Press release: Withdrawal of pain medicine flupirtine endorsed
CMDh, Last updated: 23/03/2018several trade names and in different formulations … several trade names and in different formulations … Germany, under Article 31 of Directive 2001/83/EC. The review …