New EPARs by EMA. Help your registration!

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    New EPARs by EMA. Help your registration!

    New EPARs by EMA. Help your registration!

    Another week and EMA has released new EPARs for several products. Since you may be thinking about registering a product with their active substance, you may want to take a look.

    • Filgrastim Hexal: a solution for injection or infusion (drip into a vein) in a prefilled syringe. It contains the active substance filgrastim (30 or 48 million units).
    • Hexacima: a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, the hepatitis B virus, and inactivated polioviruses.
    • Thyrogen: a powder that is made up into a solution for injection. It contains the active substance thyrotropin alfa.
    • Daklinza is an antiviral medicine used in combination with other medicines to treat chronic (long-term) hepatitis C (an infectious disease of the liver, caused by the hepatitis C virus) in adults. It contains the active substance daclatasvir.
    • Caspofungin Accord is an antifungal medicine used to treat adults, adolescents and children. Caspofungin Accord is a powder that is made up into a solution for infusion (drip) into a vein. It contains the active substance caspofungin.
    • Ameluz is used in adults to treat mild to moderate actinic keratoses on the face and scalp as well as the surrounding areas of the skin affected by the condition. The medicine contains the active substance 5-aminolaevulinic acid.
    • Rotarix is a vaccine that contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
    • Optaflu is a vaccine that contains ‘surface antigens’ from three different strains (types) of influenza (flu) virus: A/California/7/2009 (H1N1)pdm09-like strain; A/Switzerland/9715293/2013 (H3N2)–like strain; and B/Phuket/3073/2013-like strain.


    Since this is a selection of the EPARs. For more information, get in contact with us at info@baupharma.com or check EMA’s website.


    • Zytiga is a medicine used to treat cancer of the prostate. It contains the active substance abiraterone acetate.
    • Pandemic influenza vaccine H5N1 MedImmune is a vaccine developed to protect children aged between 12 months and 18 years against influenza (flu) during a flu pandemic. Pandemic influenza vaccine H5N1 MedImmune contains live, attenuated (weakened) influenza A virus A/Vietnam/1203/2004 (H5N1) strain.
    • Vaxelis is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, the hepatitis B virus, and inactivated polioviruses. It is used in babies and toddlers aged from six weeks.
    • Ravicti is a medicine used long-term to manage urea-cycle disorders in adults and children from the age of two months, when the diseases cannot be managed by changes in their diet alone. Ravicti contains the active substance glycerol phenylbutyrate.
    • Simponi is an anti-inflammatory medicine. Simponi contains the active substance golimumab.
    • Caprelsa is a cancer medicine that is used in adults and children above 5 years of age to treat medullary thyroid cancer. Caprelsa contains the active substance vandetanib.
    • Enbrel is an anti-inflammatory medicine. Enbrel contains the active substance etanercept.
    • Eliquis is used to prevent venous thromboembolism (blood clots in the veins) in adults. Eliquis is a medicine that contains the active substance apixaban.
    • Ivabradine JensonR contains the active substance ivabradine.
    • Evotaz is an antiviral medicine used in combination with other medicines to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Evotaz contains the active substances atazanavir and cobicistat.


    Why is the EPAR important? How can it save you a lot of time and struggle during your registration?


    First of all, when the EPAR is published it usually comes along with SmPC, PIL and labels. For instance, You can use these documents as reference for your medical writing. It will save you time but also, EMA  recommends the use of approved  products as reference to ensure consistency. Secondly, once you have to present the Consultation with Target Patient Groups you won’t have to do a full readability testing. If you have other products registered and approved, you can use one of the mockups as a reference and perform a Double Bridging Report. If you don’t know how, get in contact with us, we can help you with it.

    Last but not least, SmPC, PIL and labelling is published in all official EU languages. What does it mean? As a result of the use of part of the original text,  you will be able to update the documentation in the target languages easily. Consequently, you are having the same question again. Yes, we also can help you with that. Our translators with pharmaceutical and medical background are ready to perform any update according to EMA and local requirements. Since all of our translators only translate into their native language, this ensures consistency and coherence.

    Baupharma – Regulatory Affairs

    Baupharma is a service provider for pharmaceuticals. We are focused in Regulatory Affairs, Pharmacovigilance and Business Development. Our regions of expertise are EU, CIS and MENA.

    If you want more information about the topic, get in contact with us at info@baupharma.com