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Direct healthcare professional communication (DHPC): Omega-3-acid ethyl ester medicines: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors (updated)
Active substance: Omega-3 fatty acid ethyl esters, DHPC type: Adverse event, Last updated: 01/12/2023 -
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Referral: Pseudoephedrine-containing medicinal products (updated)
pseudoephedrine, Article 31 referrals
Status: Recommendation provided by Pharmacovigilance Risk Assessment Committee, Last updated: 01/12/2023 -
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Direct healthcare professional communication (DHPC): Ozempic (semaglutide) and Victoza (liraglutide): Supply shortage (updated)
Active substance: semaglutide, liraglutide, DHPC type: Medicine shortage, Last updated: 01/12/2023 -
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Direct healthcare professional communication (DHPC): Integrilin (eptifibatide): Discontinuation of manufacturing of Integrilin (updated)
Active substance: eptifibatide, DHPC type: Medicine shortage, Last updated: 01/12/2023 -
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Referral: Topiramate (updated)
topiramate, Article 31 referrals
Status: CMDh final position, opinion/position date: 10/11/2023, Last updated: 23/11/2023 -
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Referral: Ocaliva (updated)
obeticholic acid, associated names: Ocaliva, Article 20 procedures
Status: Procedure started, Last updated: 10/11/2023 -
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Referral: Havrix (updated)
hepatitis A virus (inactivated, adsorbed), associated names: Havrix and associated names, Article 30 referrals
Status: Under evaluation, opinion/position date: 14/09/2023, Last updated: 10/11/2023 -
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Referral: Hydroxyprogesterone-containing medicinal products
hydroxyprogesterone, associated names: Lentogest, Progesterone Retard Pharlon, Proluton