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239 results

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Categories Human Remove Human filter

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter

Referral status European Commission final decision Remove European Commission final decision filter Opinion provided by Committee for Medicinal Products for Human Use Remove Opinion provided by Committee for Medicinal Products for Human Use filter Under evaluation Remove Under evaluation filter

Referral type Article 30 referrals Remove Article 30 referrals filter Article 13 referrals Remove Article 13 referrals filter Article 107 procedures (prior to July 2012) Remove Article 107 procedures (prior to July 2012) filter Article 20 procedures Remove Article 20 procedures filter Article 31 referrals Remove Article 31 referrals filter

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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: Zinbryta

daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, Last updated: 11/07/2018
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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
List item

Referral: Picato

ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 06/07/2020, Last updated: 16/11/2020
List item

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
List item

Referral: Aprotinin

aprotinin, associated names: Trasylol, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 15/11/2007, EC decision date: 15/02/2008, Last updated: 22/11/2007
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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
List item

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: Basiron AC and associated names

benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019
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Referral: Benfluorex

benfluorex, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 14/06/2010, Last updated: 27/07/2011
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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
List item

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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239 results

Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions

Referral: Zinbryta

Referral: Factor VIII

Referral: Micro Therapeutic Research

Referral: Cozaar Comp

Referral: Sibutramine

Referral: Baxter dialysis solutions

Referral: Semler

Referral: Alkem

Referral: Picato

Referral: Adrenaline auto-injectors

Referral: Agopton

Referral: Agreal

Referral: Amoxil

Referral: Anorectics

Referral: Antifibrinolytic medicines

Referral: Aprotinin

Referral: Arimidex

Referral: Atacand

Referral: Atacand Plus

Referral: Augmentin

Referral: Basiron AC and associated names

Referral: Benfluorex

Referral: Bicalutamide 150 mg

Referral: Bisphosphonates