News and Media

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 […]

Levor 5 mg/ml infusion solution is a medicinal product of Tchaikapharma High Quality Medicines Inc., for which the Bulgarian Drug Agency issued a marketing authorisation in January 2016. The active substance is levofloxacin as levofloxacin hemihydrate. Levor should be used in adults for treatment of the following infections: Community acquired pneumonia; Complicated skin and soft-tissue […]

The Bulgarian Drug Agency issued a marketing authorisation for the medicinal product Cisaxa 2mg/ml injection/ infusion solution. The medicine is a neuromuscular blocking agent with average duration of action for intravenous administration with quantitative composition cisatracurium 2 mg (as cisatracurium besilate 2.68 mg per 1 ml). Cisaxa should be used during surgical and other procedures […]

The Bulgarian Drug Agency has issued a marketing authorisation for the medicinal product Remifentanil-Tchaikapharma 1 mg, 5 mg powder for concentrate for solution for injection/infusion, containing the active substance remifentanil and belonging to a group of medicines known as opiates. Remifentanil-Tchaikapharma is used together with other medicines called anaesthetics to: Facilitate falling asleep before surgery; […]

Tchaikapharma High Quality Medicines Inc. has obtained a new marketing authorisation for the medicinal product Coolsart – 20 mg/12.5 mg, 20 mg/25 mg, 40 mg/12.5 mg, 40 mg/25 mg film-coated tablets. Coolsart contains two active substances: olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension). Olmesartan medoxomil belongs to the group […]