List of medicinal products under additional monitoring

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EMA/245297/2013 Rev.2Patient Health Protection List of medicinal products under additional monitoring Related Information:
pecial_topics/document_listing/document_listing_000365.jsp
egulation/document_listing/document_listing_000345.jsp Product name
Active Substance (s)
Reason (s) on list
Marketing Authorisation Holder (s)
Link to Product Information

New active substance, conditional authorisation Takeda Global Research and Development Centre (Europe) Ltd.
Authorised under exceptional circumstances Authorised under exceptional circumstances Authorised under exceptional circumstances Meningococcal group-B vaccine (rDNA, component, adsorbed) Novartis Vaccines and Diagnostics S.r.l.
New active substance, conditionial authorisation New active substance, conditional authorisation Authorised under exceptional circumstances Cleviprex emulsion for injection 0.5 mg/ml Takeda Global Research and Development Centre (Europe) Ltd.
Authorised under exceptional circumstances Dihydroartemisinin / piperaquine phosphate Sigma-tau Industrie Farmaceutiche Riunite S.p.A.
Emtricitabine / rilpivirine / tenofovir disoproxil Authorised under exceptional circumstances New active substance, conditional authorisation Authorised under exceptional circumstances Influenza vaccine (intranasal, live attenuated) New active substance, Authorised under exceptional circumstances Diphtheria, tetanus, pertussis (acel ular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate Diphtheria, tetanus, pertussis (acel ular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type B conjugate Authorised under exceptional circumstances Authorised under exceptional circumstances Takeda Global Research and Development Centre (Europe) Ltd.
Authorised under exceptional circumstances Concentrate of proteolytic enzymes enriched in bromelain Meningococcal group A, C, W 135 and Y conjugate vaccine Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a) New active substance, conditional authorisation Authorised under exceptional circumstances Authorised under exceptional circumstances Takeda Global Research and Development Centre (Europe) Ltd Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil Tocofersolan d-alpha tocopheryl polyethylene glycol succinate Authorised under exceptional circumstances Authorised under exceptional circumstances A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cel derived, New active substance, authorised under exceptional circumstances Authorised under exceptional circumstances New active substance, conditional authorisation Authorised under exceptional circumstances 1PASS: Post-authorisation safety study. A study designed to confirm, further characterise or refute a safety signal which has been associated with a specific drug.
2 Also known in some EU countries as Tyvense3 Also known in some EU countries as Fluarix Tetra

Source: http://www.castelvetranoselinunte.it/files/Lista-farmaci-EMA.pdf