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Medicine
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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: Cozaar Comp
losartan + hydrochlorothiazide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/04/2008, EC decision date: 03/09/2008, Last updated: 25/09/2008 -
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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: Actira
moxifloxacin, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 20/03/2008, EC decision date: 14/07/2008, Last updated: 13/10/2008 -
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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: Agopton
Lansoprazole, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/09/2006, EC decision date: 13/12/2006, Last updated: 20/12/2006 -
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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: Amoxil
amoxicillin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/06/2015, EC decision date: 20/08/2015, Last updated: 19/05/2016 -
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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: Arcoxia
etoricoxib, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 26/06/2008, EC decision date: 09/09/2008, Last updated: 21/11/2008 -
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Referral: Arimidex
anastrozole, Article 30 referrals
Status: European Commission final decision, opinion/position date: 17/03/2011, EC decision date: 18/05/2011, Last updated: 27/07/2011 -
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Referral: Atacand
candesartan, associated names: Amias, Blopress, Kenzen, Racanda, Ratacand, Parapres, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 13/07/2010, Last updated: 16/03/2011 -
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Referral: Atacand Plus
candesartan / hydrochlorothiazide, associated names: Atacand Zid, Blopresid, Blopress Comp, Blopress Plus, CoKenzen, Hytacand, Parapres Plus, Ratacand Plus, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/06/2010, EC decision date: 16/09/2010, Last updated: 21/09/2011 -
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Referral: Augmentin
amoxicillin and clavulanic acid, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/01/2009, EC decision date: 19/10/2009, Last updated: 18/11/2013 -
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Referral: Avelox
moxifloxacin, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 20/03/2008, EC decision date: 14/07/2008, Last updated: 13/10/2008 -
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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: Bifril, Teoula, Zofepril, Zopranol
zofenopril, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 27/07/2000, EC decision date: 29/11/2000, Last updated: 29/11/2000 -
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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