Cancellation of state registration. Chloropyramine-ESCOM

March 28, 2017
Active substances:
ICD-10:
X.J30-J39.J30.1    Allergic rhinitis caused by pollen of plants
X.J30-J39.J30.2    Other seasonal allergic rhinitis
XII.L20-L30.L20.8    Other atopic dermatitis
XII.L20-L30.L23    Allergic contact dermatitis
XII.L20-L30.L24    Simple irritant contact dermatitis
XII.L20-L30.L29    Itching
XII.L20-L30.L30.0    Coin-like eczema
XII.L50-L54.L50    Hives
XIX.T66-T78.T78.3    Angioedema
XIX.T80-T88.T80.6    Other serum reactions
XIX.T80-T88.T88.7    Pathological reaction to medication or medicines, unspecified
Chloropyramine, a blocker of H1-histamine receptors, an antiallergic drug, allergic rhinitis, allergic dermatitis, pruritus, atopic dermatitis, urticaria

The Ministry of Health of the Russian Federation in accordance with articles 29 and 32 of the Federal Law of 12.04.2010 No. 61-FZ "On circulation of medicines" decided to abolish state registration and exclude from the state register of medicinal products for medical use of the medicinal product (registration certificate LG1- 000761 dated September 29, 2011, Open Joint-Stock Company Research and Production Concern "ESCOM" (OAO NPK "ESCOM"), Russia):

Chloropyramine-ESCOM (trade name of the medicinal product)

Chloropyramine (international non-proprietary, or grouping, or chemical name medicinal product)

solution for intravenous and intramuscular administration, 20 mg / ml (dosage form, dosage)

Open Joint-Stock Company Research and Production Concern "ESCOM" (OAO NPK "ESCOM"), Russia 355107, Stavropol, Staromaryevskoe highway, 9G (name and address of the place of production)

in connection with the non-confirmation of the state registration of the medicinal product for medical use according to the results of the examination of the quality of the expected benefit of the drug.