GIF decided to withdraw a batch of Ivoxel from the market nationwide. An ointment that is used to relieve symptoms caused by certain inflammatory skin diseases.
The Main Pharmaceutical Inspectorate decided to withdraw from the national market a batch of the medicinal product Ivoxel (Mometasoni furoas), 1 mg / g, emulsion for skin, 60 g, with the batch number: 703461 and the expiry date: 01.2019.
The responsible entity is Almirall Hermal GmbH.
The decision was made immediately enforceable.
The reason for the decision was the fact that the result was out of specification during stability studies in the field of the parameter: uniformity of dosed units.
Indications: In adults and children 6 years of age and older, Ivoxel ointment is used to relieve symptoms caused by some inflammatory skin diseases, such as psoriasis (excluding widespread ordinary psoriasis) and atopic dermatitis. Ivoxel ointment is mainly used to treat a skin condition that manifests as very dry, flaky and cracked skin. In adults and children 2 years of age and older, Ivoxel cream is used to relieve the symptoms caused by some inflammatory skin diseases, such as psoriasis (excluding widespread psoriasis vulgaris) and atopic dermatitis. Ivoxel will not cure your disease but should help relieve your symptoms.