This decision was made by the department on Friday, February 22.
See also: Prohibition of drugs: what drugs are banned in Ukraine
Under a temporary ban were drugs that were prescribed for bronchial asthma, obstructive bronchitis, and also for the treatment of symptoms of the respiratory system:
• AMISPIRON IC, film-coated tablets with prolonged action, 0.08 g to 10 tablets in a blister, 1 or 2 blisters per pack of cardboard of all series. Producer – ODO "INTERCHEM", Ukraine
• BRONHOMAX syrup, 10 mg / 5 ml, 100 ml each in vials No. 1, 200 ml each, in vials No. 1 of all series. Producer – Pharmaceutical Company Health, Ltd., Ukraine; Kharkiv Pharmaceutical Enterprise Zdorovye Noda, Ltd., Ukraine.
• BRONHOMAX coated tablets with a modified release of 80 mg, 10 tablets in a blister; 2 or 3 blisters in a cardboard box of all series. The manufacturer of the drug is LLC "Pharmaceutical company" Health ", Ukraine; LLC" FARMEX GROUP ", Ukraine.
• INSPIRON, syrup, 2 mg / ml and 4 mg / ml, 150 ml each in bottles No. 1 in a pack of all series. The producer is PJSC "Halychpharm", Ukraine, Lviv.
• INSPIRON, tablets, film coated, on 80 mg, on 10 tablets in the blister, 3 blisters in a pack of all series. The producer is PAO "Kievmedpreparat", Ukraine.
• SINUSPAL, syrup, 200 mg / 100 ml in 100 ml vial, 1 vial per pack with a dosing spoon of all series. Manufacturer – PJSC "Farmak", Ukraine.
• FENSPYRIDA HYDROCHLORIDE, powder (substance) in double bags of plastic film for the production of non-sterile dosage forms of all series. Producer – Errijiere S.P.A., Italy.
• FOSIDAL, syrup, 2 mg / ml, 150 ml in a vial; on 1 bottle with a measured spoon in a box of all series. The manufacturer of medicines is MEDANA PHARMA Joint-Stock Company, Poland.
The active ingredient of all of the above medicines – fenspiride – can lead to heart rhythm disturbances, myocardial infarction, infectious or allergic damage to the heart muscle. In addition to heart problems, fenspirid can cause side effects such as drowsiness and hardening, pain in the gall, etc., and skin problems.
On February 8, the French National Agency for the Safety of Medicines and Health Products temporarily banned the use of preparations containing this active ingredient. To investigate the relationship between fenspiride and cardiac arrhythmias, they conducted a study on animals. The experiment showed that fenspiride is able to continue the Q-T interval. And this can lead to myocardial infarction, damage to the heart muscle. In France, drugs are withdrawn based on this substance from circulation.
Gosleksluzhba also partially lifted the ban on the GS01701, GS01702 series of the SIGAN medicinal product, film-coated tablets, No. 4 (4×1) in strips manufactured by Jen Biotech Pvt. Ltd., India. The reason for this was the positive results of additional research on all indicators. Prohibited are the drugs series GS01703.
Recall that on Friday, February 15, the ministry banned medicines for respiratory manifestations of measles and flu "Erespal" with the active substance fenspiride.
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