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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions
Haemophilus influenzae / Klebsiella pneumoniae / Moraxella catarrhalis / Staphylococcus aureus / Streptococcus mitis / S. pneumoniae / S. pyogenes, H. influenzae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes, S. pneumoniae / S. agalactiae / Staphylococcus aureus / H. influenzae, H. influenzae / K. ozaenae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes / S. viridans, H. influenzae / membrane fraction of K. pneumoniae / ribosomal fractions of K. pneumoniae / S. pneumoniae / S. pyogenes, Escherichia coli / K. pneumoniae / S. aureus / S. epidermidis / S. salivarius / S. pneumoniae / S. pyogenes / H. influenzae / Corynebacterium pseudodiphtheriticum / M. catarrhalis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2019, EC decision date: 09/09/2019, Last updated: 16/09/2019 -
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Referral: Factor VIII
associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017 -
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Referral: Micro Therapeutic Research
-, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/03/2017, EC decision date: 23/06/2017, Last updated: 10/07/2017 -
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Referral: Sibutramine
Sibutramine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2002, EC decision date: 26/03/2001, Last updated: 13/12/2002 -
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Referral: Baxter dialysis solutions
Baxter dialysis solutions, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013 -
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Referral: Semler
Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 17/11/2016 -
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Referral: Alkem
Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2016, EC decision date: 08/09/2016, Last updated: 07/10/2016 -
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Referral: Adrenaline auto-injectors
adrenaline (epinephrine), Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/06/2015, EC decision date: 14/08/2015, Last updated: 26/08/2015 -
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Referral: Agreal
veralipride, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/07/2007, EC decision date: 01/10/2007, Last updated: 07/01/2008 -
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Referral: Anorectics
amfepramome, clobenzorex, dexfenfluramine, fenbutrazate, fenfluramine, fenproporex, mazindol, mefenorex, norpseudoephedrine, phenmetrazine, phendimetrazine, phentermine and propylhexedrine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/02/1996, EC decision date: 09/12/1996, Last updated: 10/12/1996 -
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Referral: Antifibrinolytic medicines
aprotinin, aminocaproic acid, tranexamic acid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/06/2012, Last updated: 06/11/2013 -
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Referral: Bicalutamide 150 mg
bicalutamide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/05/2007, EC decision date: 03/09/2007, Last updated: 03/10/2007 -
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Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
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Referral: Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum
bromocriptine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/08/2014, EC decision date: 30/10/2014, Last updated: 08/12/2014 -
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Referral: Calcitonin
calcitonin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 13/02/2013, Last updated: 19/07/2013 -
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Referral: Calcitonins
calcitonin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/11/2002, EC decision date: 12/06/2003, Last updated: 02/03/2004 -
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Referral: Caustinerf arsenical and Yranicid arsenical
ephedrine hydrochloride, lidocaine and arsenous anhydride, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/04/2014, EC decision date: 11/07/2014, Last updated: 06/08/2014 -
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Referral: Celecoxib
celecoxib, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 28/11/2005, Last updated: 06/12/2005 -
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Referral: Celecoxib
celecoxib, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/11/2003, EC decision date: 29/04/2004, Last updated: 09/06/2004 -
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Referral: Chlormezanone
chlormezanone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/01/1997, EC decision date: 27/08/1997, Last updated: 22/09/1997 -
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Referral: Cilostazol-containing medicines
cilostazol, associated names: Pletal, Ekistol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2013, EC decision date: 24/06/2013, Last updated: 11/09/2013 -
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Referral: Cisapride
cisapride, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2001, EC decision date: 30/05/2002, Last updated: 29/10/2002 -
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Referral: Polymyxin-containing medicines
colistimethate sodium, associated names: Colobreathe, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 16/12/2014, Last updated: 05/01/2015 -
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Referral: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014 -
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Referral: Cyproterone- and ethinylestradiol-containing medicines
cyproterone / ethinylestradiol, associated names: Acnemine, Acneson, Chloe, Clairette, Cyprest, Cyprodiol, Diane 35, Dianette, Feminil, Minerva, Zyrona, Article 107i procedures
Status: European Commission final decision, opinion/position date: 29/05/2013, EC decision date: 25/07/2013, Last updated: 05/08/2013