Cancellation of state registration. Daltiphen®

May 15, 2018
Active substances:
Trade names:
ICD-10:
VII.H10-H13.H10.1    Acute atopic conjunctivitis
X.J30-J39.J30.1    Allergic rhinitis caused by pollen of plants
X.J30-J39.J30.3    Other allergic rhinitis
X.J40-J47.J45    Asthma
XII.L20-L30.L20.8    Other atopic dermatitis
XII.L20-L30.L23    Allergic contact dermatitis
XII.L20-L30.L24    Simple irritant contact dermatitis
XII.L50-L54.L50    Hives
Daltiphen, ketotifen, allergic conjunctivitis, the prevention of allergic diseases, allergic bronchitis, allergic rhinitis, allergic dermatitis

The Ministry of Health of the Russian Federation, in accordance with Article 32 of Federal Law No. 61-FZ of 12.04.2010 "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 LP-002663 from 10/20/2014 issued to Micro Lab Limited, India):

Daltiphen® (trade name of the medicinal product)

Ketotifen (international non-proprietary or chemical name of the drug)

eye drops, 0.05% (dosage form, dosage)

Micro Labe Limited, India Plot No. 113 to 116, K.I.A.D.B., Bommasandra Industrial Area, Anekal Taluk, Bangalore - 560 099, India (name and address of the location of the manufacturer of the medicinal product)

On the basis of a filing by an authorized legal entity of the "Micro Lab Company Limited" (India), Russia, a request to cancel the state registration of a medicinal product.