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After successfully completing the third for the company Decentralised Procedure (DCP) Tchaikapharma High Quality Medicines Inc. received Marketing Authorisation for the medicinal product Tamayra 5 mg/5 mg hard capsules and Tamayra 10 mg/5 mg hard capsules, for which Bulgaria is the country of reference

This is the first international procedure for Marketing Authorisation of medicinal products for which our country is the reference country. Concerned are six European countries – the Czech Republic, Romania, Portugal, Slovakia, Greece and Austria.

Tamayra belongs to a group of modern combined drug therapies for cardiovascular diseases based on ACE inhibitors and calcium channel blockers.

ATC code: C09BB 07

Tchaikapharma High Quality Medicines Inc. was granted Marketing Authorisations for the medicinal products Ibodria 6 mg/6 ml concentrate for solution for infusion and Ibodria 3 mg/3 ml solution for injection in pre-filled syringe. The active substance contained is Ibandronic acid (as ibandronate sodium monohydrate).

The medicinal product is indicated for the treatment of osteoporosis in postmenopausal women with increased risk of fracture. A reduction in the risk of vertebral fractures is proven.
Ibodria is subject to medical prescription.

ATC code: M05BA 06

The Bulgarian Pharmaceutical Union awarded Tchaikapharma High Quality Medicines Inc. for cardiological medicinal product Amariton in the category “Medicinal Product Subject to Medicinal Prescription – made in Bulgaria” for 2016. The Awards ceremony took place at the Tenth anniversary edition of the Bulgarian Pharmaceutical Days, held from the 24th to 26th of June 2016 at the National Palace of Culture, Sofia.

Tchaikapharma High Quality Medicines Inc. was granted Marketing Authorisations for the medicinal products Atorva 40 mg and 80 mg film-coated tablets. Each tablet contains the active substance atorvastatin as atorvastatin calcium.

Atorva is indicated:

– as an adjunct to diet to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in adults, adolescents and children over the age of 10 with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) and combined (mixed) hyperlipidemia (corresponding to Fredrickson’s classification type IIa and IIb), when response to diet and other non-pharmacological methods is insufficient;

– for lowering total cholesterol and LDL-C in adult patients with homozygous familial hypercholesterolemia as an adjunct to other methods of decreasing the level of lipids (e.g. LDL Apheresis) or in cases where these methods are not available;

– for prevention of cardiovascular events in adult patients at high risk for a first cardiovascular event as an adjunct to correction of other risk factors.

Atorva is subject to medical prescription.

ATC code: C10AA 05

On 10/05/2016, the BDA successfully completed within the specified period the first decentralised procedure (DCP) for marketing authorisation of medicinal products for which Bulgaria is the Reference Member State (RMS).
A team of experts from the BDA assessed the documentation, in connection with the Marketing Authorisation of medicinal products Tamayra 5 mg/5 mg hard capsules and Tamayra 10 mg/5 mg hard capsules, with Marketing Authorisation Holder Tchaikapharma High Quality Medicines Inc., Bulgaria. The procedure was adopted by the other six Concerned Member States (CMSs) as well.