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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: Numeta G13%E and Numeta G16%E emulsion for infusion
Article 107i procedures
Status: CMDh final position, opinion/position date: 18/09/2013, Last updated: 27/09/2013 -
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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: Suvaxyn Parvo/E
Articles 39 and 40
Status: European Commission final decision, opinion/position date: 17/01/2007, EC decision date: 17/04/2007, Last updated: 15/11/2007 -
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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: Solacyl
Article 33
Status: European Commission final decision, opinion/position date: 13/02/2008, EC decision date: 17/04/2008, Last updated: 07/12/2011 -
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Referral: Bovilis BVD
Article 33
Status: European Commission final decision, opinion/position date: 17/04/2007, EC decision date: 29/06/2007, Last updated: 07/12/2011 -
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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: Suvaxyn Ery
Articles 39 and 40
Status: European Commission final decision, opinion/position date: 17/01/2007, EC decision date: 19/04/2007, Last updated: 15/11/2007 -
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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020 -
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Direct healthcare professional communication (DHPC): Mepact 4mg (mifamurtide): Potential for filter leakage or malfunction
Active substance: mifamurtide, DHPC type: Quality defect, Last updated: 25/02/2020 -
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Direct healthcare professional communication (DHPC): Ecalta 100mg powder for concentrate for solution for infusion (anidulafungin) - Solution for infusion must no longer be frozen
Active substance: anidulafungin, DHPC type: Quality defect, Last updated: 14/02/2020 -
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Direct healthcare professional communication (DHPC): Restrictions in use of cyproterone acetate due to risk of meningioma
Active substance: cyproterone, DHPC type: Referral - Article 31, Last updated: 29/04/2020 -
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Direct healthcare professional communication (DHPC): Brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine
Active substance: Brivudine, DHPC type: Periodic safety update single assessment, Last updated: 12/05/2020 -
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Direct healthcare professional communication (DHPC): Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk
Active substance: ulipristal acetate, DHPC type: Interim measures, Last updated: 23/03/2020 -
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Direct healthcare professional communication (DHPC): Tepadina (thiotepa) 100 mg: possible risk of defective vials in batches n°1709192/1, n°1709192/2 and n°1709192/3 presenting a crimp seal not properly fixed on the vial
Active substance: thiotepa, DHPC type: Quality defect, Last updated: 02/06/2020 -
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Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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Direct healthcare professional communication (DHPC): Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency
Active substance: Flucytosine, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa
Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020 -
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Direct healthcare professional communication (DHPC): Insuman Implantable 400 IU/ml insulin solution for infusion: no new patients should be started due to discontinuation of MiniMed Implantable Pump
Active substance: insulin human, DHPC type: Type II variation, Last updated: 21/07/2020