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25 results
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products (updated)
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 30/04/2020, Last updated: 30/04/2020 -
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Referral: Ranitidine-containing medicinal products (updated)
ranitidine, Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 19/09/2019, Last updated: 30/04/2020 -
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Referral: Picato (updated)
ingenol mebutate, associated names: Picato, Article 20 procedures
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 30/04/2020, Last updated: 30/04/2020 -
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Referral: Budesonide SUN (updated)
budesonide, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 26/03/2020, Last updated: 30/04/2020 -
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Referral: Fosfomycin-containing medicinal products (updated)
fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, associated names: Afastural, Berny Adulti, Danifos Adulti, Fomicyt, Fosfocin, Fosfocina, Fosfocine, Fosfopharm, Fosfuro, Fosmol, Fostrofemge, Gynofostrome, Infectofos, Infeur Adulti, Interfos, Monural, Monuril, Monurol, Rapidnorm, Solufos, Symural, Uridoz, Urifos, Urinex, Urofast, Uromaste, Uroseptic, Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 26/03/2020, Last updated: 29/04/2020 -
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Referral: Methocarbamol / paracetamol-containing medicinal products
methocarbamol/paracetamol, associated names: Robaxisal compuesto, Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 26/03/2020, Last updated: 27/03/2020 -
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Referral: Symbioflor 2
Escherichia coli bacteria (cells and autolysate), associated names: Symbioflor E. Coli, Symbioflor® 2, Symbioflor Escherichia, Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, EC decision date: 22/06/2017, Last updated: 07/09/2017 -
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Referral: Durogesic and associated names
fentanyl, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 19/10/2016 -
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Referral: Merisone and associated names
tolperisone, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 23/04/2015, EC decision date: 25/06/2015, Last updated: 28/07/2015 -
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Referral: Oxynal-Targin and associated names
oxycodone hydrochloride / naloxone hydrochloride, Article 13 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 23/10/2014, EC decision date: 22/12/2014, Last updated: 27/01/2015 -
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Referral: ATryn
Test, Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, Last updated: 01/01/2015 -
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Referral: Sandostatin and associated names
octreotide, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 26/06/2014, Last updated: 27/06/2014 -
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Referral: Sandostatin LAR and associated names
octreotide, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 26/06/2014, Last updated: 27/06/2014 -
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Referral: Methysergide-containing medicines
methysergide, associated names: Deseril, Desernil, Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 20/02/2014, EC decision date: 28/04/2014, Last updated: 27/05/2014 -
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Referral: Sandimmun and associated names
ciclosporin, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 27/06/2013, EC decision date: 31/10/2013, Last updated: 20/12/2013 -
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Referral: Vivaglobin
Human normal immunoglobulin, Article 36 referrals (prior to July 2012)
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 16/02/2012, EC decision date: 07/05/2012, Last updated: 18/11/2013 -
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Referral: Preflucel
influenza vaccine, purified antigen, Article 36 referrals (prior to July 2012)
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 19/07/2012, Last updated: 20/07/2012 -
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Referral: Levothyroxine Alapis
levothyroxine sodium, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/10/2012, EC decision date: 14/01/2013, Last updated: 19/01/2012 -
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Referral: Fortum
ceftazidime, associated names: Cefortam, Glazidim, Panzim, Solvetan, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 21/10/2010, EC decision date: 13/01/2011, Last updated: 22/10/2010 -
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Referral: Escitalopram
escitalopram, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/02/2010, Last updated: 29/09/2010 -
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Referral: Octegra
moxifloxacin, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 19/03/2009, EC decision date: 02/10/2009, Last updated: 25/06/2009 -
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Referral: Fentrix
fentanyl, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 25/06/2009, EC decision date: 06/10/2009, Last updated: 25/06/2009 -
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Referral: Trimetadizine-ratiopharm
trimetazidine, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 22/01/2009, Last updated: 22/01/2009 -
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Referral: Mephatrim
trimetazidine, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 22/01/2009, Last updated: 22/01/2009 -
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Referral: Carbamazepin Tillomed
carbamazepin, associated names: Carbamazepin Tillomed, Carbamazepina Tillomed, Karbamazepin Tillomed, Karbamazepina Tillomed, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 30/04/2020, Last updated: 30/04/2020