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35 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Opinion provided by Committee for Medicinal Products for Human Use Remove Opinion provided by Committee for Medicinal Products for Human Use filter
Referral type
Article 5(11) referrals (prior to January 2010) Remove Article 5(11) referrals (prior to January 2010) filter
Article 29(4) referrals Remove Article 29(4) referrals filter
Article 30 referrals Remove Article 30 referrals filter
Article 13 referrals Remove Article 13 referrals filter
Article 31 referrals Remove Article 31 referrals filter
Referral authorisation model
Nationally authorised product(s) Remove Nationally authorised product(s) filter
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Referral: Paracetamol modified-release
paracetamol, associated names: Alvedon, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2017, EC decision date: 19/02/2018, Last updated: 01/03/2018 -
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Referral: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 12/01/2018 -
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol, bromhexine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, Last updated: 05/02/2016 -
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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: Diacerein-containing medicines for oral administration
diacerein, associated names: Zondar, Article 31 referrals
Status: European Commission final decision, EC decision date: 04/09/2014, Last updated: 19/09/2014 -
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Referral: Domperidone-containing medicines
domperidone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 01/09/2014, Last updated: 11/09/2014 -
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Referral: Zolpidem-containing medicines
zolpidem, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 23/06/2014, Last updated: 04/08/2014 -
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Referral: Substances related to nicotinic acid
acipimox, associated names: Olbetam, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/12/2013, EC decision date: 20/02/2014, Last updated: 13/03/2014 -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013 -
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Referral: Daruph and Anafezyn
dasatinib (anhydrous), associated names: Dasatinib Zentiva, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 19/05/2022, Last updated: 20/05/2022