Revocation of the State registration of drugs that had been excluded from the Company’s price long time ago

16.09.2022

The Regulatory Affairs Department of PIQ-PHARMA LLC is continuously working on the improvement of registration dossiers on medicines.

Thus, in September 2022, according to the initiative of PIQ-PHARMA LLC, the state registration of the following medicines, that had been excluded from the Company’s price long time ago, was canceled:

  • Elkar®, oral solution 200 mg/ml;
  • Pantogam®, tablets 250 mg and 500 mg, manufactured by FSUE "CNKB";
  • Kudevita®, capsules 30 mg.

Letters from the Ministry of Health of Russia on the revocation of state registration can be found at https://grls.rosminzdrav.ru/Default.aspx

Medicine Registration is canceled Registration is valid
Pantogam®
tablets		 Pantogam® tablets 250 mg, 500 mg, produced by FSUE «CNKB», Russia,
R N003489/01 dated July 16, 2009		 Pantogam® tablets 250 mg,
manufactured by PIK-PHARMA LEK LLC,
LS-000339 dated April 13, 2010

Pantogam® tablets 500 mg,
manufactured by PIK-PHARMA LEK LLC,
LP-000860 dated October 14, 2011
Elkar®
oral solution		 Elkar® oral solution 200 mg/ml, produced by OLIFEN Corporation, Russia, PIK-PHARMA PRO LLC, Russia,
LS-000184 dated March 17, 2010		 Elkar® oral solution 300 mg/ml, manufactured by PIK-PHARMA LEK LLC, Russia,
LSR-006143/10 dated June 30, 2010
Kudevita®
capsules		 Kudevita® capsules 30 mg, manufactured by PIK-PHARMA PRO LLC, Russia, PIK-PHARMA LEK LLC, Russia,
LP-000019, dated October 28, 2010		 –

At the same time, according to the plan of Regulatory Affairs Department, dossiers of the following medicines were brought into line with the regulatory requirements of the EAEU (new Registration Certificates had been received in the EAEU format):

  • Elkar® effervescent granules 1000 mg;
  • Dibicor® tablets 250 mg;
  • Dibicor® tablets 500 mg.

In the fourth quarter of 2022, it is planned to receive Registration certificates in the EAEU format for Pantogam® tablets 250 mg and Pantogam® tablets 500 mg.

Information about all relevant Registration Certificates and Leaflets is posted on the Company`s website in the "Drugs" section: https://www.piqpharma.com/production/

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