Letter to manufacturers of medicinal products with the international nonproprietary name “umifenovir” regarding the need to amend the instructions for medical use
In accordance with the minutes of the meeting of the working group on the review of materials for medicinal products registered in Ukraine that are used for the treatment and prevention of influenza and acute respiratory viral infections (ARVI) and have antiviral and/or immunomodulating action, and on bringing them into line with reliable data on the efficacy and safety of medicinal products, dated 14.01.2015, the Ministry of Health of Ukraine announces the need to amend the package leaflets of the following medicinal products with the international nonproprietary name “umifenovir”:
Arbidol®, film-coated tablets, 50 mg, 100 mg (applicant – JSC “Pharmstandard – Tomskhimpharm”),
Arbidol®, capsules, 100 mg, No. 10 (5x2), No. 10 (10x1), No. 20 (10x2) in blisters in a pack (applicant – JSC “Pharmstandard-Leksredstva”)
Arbivir-Zdorovia, film-coated tablets, 50 mg; Arbivir-Zdorovia forte, film-coated tablets, 200 mg; Arbivir-Zdorovia, capsules, 100 mg; Arbivir-Zdorovia forte, capsules, 200 mg – applicant LLC “FC Zdorovia”),
Imustat, coated tablets, 50 mg, 100 mg (applicant – PJSC “PF “Darnitsa”),
Arpeflu, film-coated tablets, 50 mg, 100 mg, No. 10 (10x1), No. 30 (10x3) in blisters (applicant – LLC with foreign investments “Lekpharm”),
and also to submit applications for changes and materials to the Administrative Services Center of the Ministry of Health of Ukraine “Single Window” within 30 days from the date of publication of the notice.
We inform you that, if the relevant changes and additions are not made, the Ministry of Health of Ukraine may decide to temporarily ban the use of the above-mentioned medicinal products by terminating the validity of their registration certificates.
Regarding the decision taken, please provide the relevant information to the Ministry of Health of Ukraine within two weeks at the address: 01601, Kyiv, Hrushevskoho St., 7.
