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FAS Explains

An inquiry from Teva was submitted to the Federal Antimonopoly Service on 14.06.2016 No Т-8843 on the principles of preparation of tender documentation for purchase of drugs with international non-proprietary name (INN) Perindopril and INN Perindopril Arginine.

For that purpose the administration prepared a clarification that with reference to point 5, clause 4 of the Law on Circulation of Medicines various (names) pharmaceutical forms with the same method of administration and use and providing achievement of the required therapeutic effect, should be considered interchangeable forms.

However, the clarification states that in prescribing information for the drugs with INN Perindopril Arginine, pharmaceutical forms “film-coated tablets”, “orodispersible tablets” in the “International Non-Proprietary Name” section specifies Perindopril Arginin” (modified international non-proprietary name)”.

With a reference to the Order on Circulation of Drugs and WHO recommendations, FAS reports that pharmaceutical products with INNs Perindopril and Perindopril Arginine, form one product market, are  interchangeable and may be used in one group of patients with equivalent indications and contraindications for use with achievement of equivalent therapeutic effect.

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