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Referral: Janus kinase inhibitors (JAKi) (updated)
tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 22/03/2023 -
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Referral: Pholcodine-containing medicinal products (updated)
pholcodine, Article 107i procedures
Status: European Commission final decision, opinion/position date: 14/12/2022, EC decision date: 06/03/2023, Last updated: 22/03/2023 -
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Referral: Topiramate (updated)
topiramate, Article 31 referrals
Status: Under evaluation, Last updated: 20/03/2023 -
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Referral: Gelisia and associated names (updated)
timolol maleate, associated names: Genoptol, Gelisia, Timolol sifi 1 mg/g gel oftalmico, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 27/02/2023, Last updated: 16/03/2023 -
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Referral: Pseudoephedrine-containing medicinal products (updated)
pseudoephedrine, Article 31 referrals
Status: Procedure started, Last updated: 16/03/2023 -
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Direct healthcare professional communication (DHPC): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage update (updated)
Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 13/03/2023 -
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Referral: Rambis and associated names (updated)
ramipril, bisoprolol fumarate, associated names: Ralbior, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 15/02/2023, Last updated: 08/03/2023 -
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Direct healthcare professional communication (DHPC): CYSTAGON (mercaptamine bitartrate)
Active substance: mercaptamine bitartrate, DHPC type: Quality defect, Last updated: 15/02/2023 -
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Referral: Amfepramone-containing medicinal products
amfepramone, associated names: Regenon, Tenuate Retard, Amfepramon-Hormosan, Regenon Retard, Article 31 referrals
Status: European Commission final decision, opinion/position date: 10/11/2022, EC decision date: 13/01/2023, Last updated: 20/01/2023 -
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Direct healthcare professional communication (DHPC): INSUMAN RAPID / INSUMAN BASAL / INSUMAN COMB 25 (insulin human): temporary supply shortage
Active substance: insulin human, DHPC type: Medicine shortage, Last updated: 16/01/2023 -
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Referral: Synchron
Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 28/11/2022, Last updated: 16/12/2022 -
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Referral: Nomegestrol and chlormadinone
nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: European Commission final decision, opinion/position date: 01/09/2022, EC decision date: 28/11/2022, Last updated: 14/12/2022 -
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Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome
terlipressin, Article 31 referrals
Status: CMDh final position, opinion/position date: 10/11/2022, Last updated: 22/11/2022 -
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Referral: Rubraca
rucaparib, associated names: Rubraca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2022, EC decision date: 21/09/2022, Last updated: 17/10/2022 -
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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone): Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 04/10/2022 -
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Direct healthcare professional communication (DHPC): Direct healthcare professional communication (DHPC): NULOJIX (belatacept): Further extension of the temporary restriction in supply up until 3Q 2023
Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 28/09/2022 -
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Direct healthcare professional communication (DHPC): Cetrorelix acetate - Cetrotide 0.25 mg Powder and solvent for injection: Temporary Shortage
Active substance: cetrorelix (as acetate), DHPC type: Medicine shortage, Last updated: 09/08/2022 -
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Referral: Daruph and Anafezyn
dasatinib (anhydrous), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 18/07/2022, Last updated: 09/08/2022 -
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Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm
Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 26/07/2022 -
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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/07/2021, EC decision date: 16/09/2021, Last updated: 08/07/2022 -
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Referral: Nasolam and associated names
midazolam, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 27/01/2022, EC decision date: 01/04/2022, Last updated: 29/04/2022 -
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Referral: Lidocain/Prilocain Idetec and associated names
lidocaine, prilocaine, associated names: Lidocaïne / Prilocaïne 5% Focus, Crème, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 14/10/2021, Last updated: 21/04/2022 -
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Referral: Etifoxine-containing medicinal products
etifoxine, associated names: Stresam, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/06/2021, EC decision date: 24/03/2022, Last updated: 21/04/2022 -
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Referral: Hydroxyethyl starch (HES) containing medicinal products
hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/10/2017, EC decision date: 17/07/2018, Last updated: 11/02/2022 -
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Direct healthcare professional communication (DHPC): CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit
Active substance: varenicline, DHPC type: Medicine shortage, Last updated: 30/09/2021