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    Market Authorization-En

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    Christian Puente
    This document is a Certificate of Pharmaceutical Product for Medical Use issued by the Ministry of Health of the Russian Federation for the drug AVIFAVIR. It summarizes that AVIFAVIR contains the active ingredient Favipiravir 200 mg and is manufactured by Joint Stock Company Issledovatelskiy Institut Khimicheskogo Raznoobraziya in Khimki, Russia. The certificate is valid from January 1, 2021 and specifies that AVIFAVIR can only be used as inpatient treatment for COVID-19 and is subject to quality control and reporting requirements.

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    Market Authorization-En

    Uploaded by

    Christian Puente
    13 views2 pages
    This document is a Certificate of Pharmaceutical Product for Medical Use issued by the Ministry of Health of the Russian Federation for the drug AVIFAVIR. It summarizes that AVIFAVIR contains the active ingredient Favipiravir 200 mg and is manufactured by Joint Stock Company Issledovatelskiy Institut Khimicheskogo Raznoobraziya in Khimki, Russia. The certificate is valid from January 1, 2021 and specifies that AVIFAVIR can only be used as inpatient treatment for COVID-19 and is subject to quality control and reporting requirements.

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    This document is a Certificate of Pharmaceutical Product for Medical Use issued by the Ministry of Health of the Russian Federation for the drug AVIFAVIR. It summarizes that AVIFAVIR contains the active ingredient Favipiravir 200 mg and is manufactured by Joint Stock Company Issledovatelskiy Institut Khimicheskogo Raznoobraziya in Khimki, Russia. The certificate is valid from January 1, 2021 and specifies that AVIFAVIR can only be used as inpatient treatment for COVID-19 and is subject to quality control and reporting requirements.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    13 views2 pages

    Market Authorization-En

    Uploaded by

    Christian Puente
    This document is a Certificate of Pharmaceutical Product for Medical Use issued by the Ministry of Health of the Russian Federation for the drug AVIFAVIR. It summarizes that AVIFAVIR contains the active ingredient Favipiravir 200 mg and is manufactured by Joint Stock Company Issledovatelskiy Institut Khimicheskogo Raznoobraziya in Khimki, Russia. The certificate is valid from January 1, 2021 and specifies that AVIFAVIR can only be used as inpatient treatment for COVID-19 and is subject to quality control and reporting requirements.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Ministry of Health of the Russian Federation

    Certificate of Pharmaceutical Product for Medical Use

    LP-006225

    (number of the certificate of pharmaceutical product)

    Name of the holder (owner) of the certificate Limited Liability Company Kromis
    of pharmaceutical product (OOO Kromis), Russia
    Address of location of the holder (owner) of 121205, Moscow, territory of Skolkovo
    the certificate of pharmaceutical product Innovation Center, 42 Bolshoy Blvd.,
    building 1, storey 0, room 264
    Date of the state registration of the May 29, 2020
    pharmaceutical product
    Period of validity of the certificate of January 1, 2021
    pharmaceutical product
    Date of modification of the certificate of Issued for the first time
    pharmaceutical product (date of update of the
    certificate of pharmaceutical product)
    Information on registered pharmaceutical product:
    Trade name AVIFAVIR
    International generic, or grouping, or Favipiravir
    chemical name
    Drug formulation Film-coated tablets
    Dosage 200 mg
    Qualitative and quantitative composition of active agents and qualitative composition of
    additive agents
    Favipiravir 200.00 mg, additive agents (microcrystalline cellulose 102, croscarmellose sodium,
    povidone K30, magnesium stearate, colloidal anhydrous silica, film coat: Opadry II 85F38183
    yellow [polyvinyl alcohol, macrogol, iron oxide yellow (E172), talc, titanium dioxide (E171)])
    Pack size (drug formulation, dosage, primary Film-coated tablets, 200 mg (blister) 10 x 4
    container, amount of drug formulation in (carton pack);
    primary container, amount of primary film-coated tablets, 200 mg (bottle) 40 x 1
    container in consumer pack, complete set) (carton pack)
    Specifications of normative documentation LP-006225-290520
    027407

    Page 2 of the certificate no. LP-006225

    Production sites taking part in the manufacture of the pharmaceutical product with reference to
    production stages, titles and actual addresses
    Manufacture of finished dosage form Joint Stock Company
    Issledovatelskiy Institut
    Khimicheskogo Raznoobraziya
    (JSC IIHR), Russia
    Moscow Region, Khimki, 2A Rabochaya Str., building 1
    Primary packaging Joint Stock Company
    Issledovatelskiy Institut
    Khimicheskogo Raznoobraziya
    (JSC IIHR), Russia
    Moscow Region, Khimki, 2A Rabochaya Str., building 1
    Secondary/consumer packaging Joint Stock Company
    Issledovatelskiy Institut
    Khimicheskogo Raznoobraziya
    (JSC IIHR), Russia
    Moscow Region, Khimki, 2A Rabochaya Str., building 1
    Manufacturer (Issuing quality control) Joint Stock Company
    Issledovatelskiy Institut
    Khimicheskogo Raznoobraziya
    (JSC IIHR), Russia
    Moscow Region, Khimki, 2A Rabochaya Str., building 1

    Special conditions for registration of the pharmaceutical product


    1. Application of the pharmaceutical product for medical use is only possible as inpatient
    treatment
    2. The pharmaceutical product for medical use is subject to obligatory random batch quality
    control of pharmaceutical products according to the legislation of the Russian Federation.
    3. Notification of the Federal Service for Surveillance in Healthcare and record of each fact
    of the pharmaceutical product application for the treatment of the new coronavirus
    infection COVID-19 in the Unified state health information system.
    4. Provision of report on research conducted according to the protocol no. COVID-FPR-01.

    Secretary of State – Deputy Minister A.V. Dronova

    /Signature/

    /Seal/: Ministry of Health of the Russian Federation. OGRN 1127746460896

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