HYFTOR Gel Ref.[50985] Active ingredients: Sirolimus

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Plusultra pharma GmbH, Fritz-Vomfelde-Str. 36, 40547 Dรผsseldorf, Germany

Product name and form

Hyftor 2 mg/g gel.

Pharmaceutical Form

Gel.

Colourless transparent gel.

Qualitative and quantitative composition

Each gram of gel contains 2 mg of sirolimus.

Excipient with known effect: Each gram of gel contains 458 mg of ethanol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sirolimus

Sirolimus inhibits T-cell activation induced by most stimuli, by blocking calcium-dependent and calcium-independent intracellular signal transduction. Studies demonstrated that its effects are mediated by a mechanism that is different from that of ciclosporin, tacrolimus, and other immunosuppressive agents.

List of Excipients

Carbomer
Anhydrous ethanol
Trolamine
Purified water

Pack sizes and marketing

Aluminium tube with high density polyethylene closure.

Pack size: 1 tube containing 10 g of gel.

Marketing authorization holder

Plusultra pharma GmbH, Fritz-Vomfelde-Str. 36, 40547 Dรผsseldorf, Germany

Marketing authorization dates and numbers

EU/1/23/1723/001

Drugs

Drug Countries
HYFTOR Austria, Estonia, Ireland, Italy, Lithuania, United States

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