Martindale Pharma’s Epaclob and Silocalm gain regulatory approval in seven European countries

Martindale Pharma, a UK-based global pharmaceutical company, has successfully secured regulatory approval for its innovative clobazam oral suspension, branded as Epaclob and Silocalm, in seven European countries. This marks a significant expansion of the company’s product availability across the continent.

Broad Regulatory Approval

The regulatory approval encompasses France, Ireland, Germany, and Italy for Epaclob, and Denmark, Spain, and Iceland for Silocalm. This broad acceptance underscores the trust and recognition of Martindale Pharma’s commitment to providing high-quality, innovative pharmaceutical solutions.

CEO’s Insight on the Approval

Michael Harris, CEO of Martindale Pharma, expressed his satisfaction with the recent approvals: “Martindale Pharma is committed to developing and providing high-quality innovative products to our customers and to patients in international markets. We are pleased to have received regulatory approval of our oral liquid formulation of clobazam in an additional seven European countries. Already an established product in the UK, this formulation not only allows for better ease of use, especially for pediatrics, but will allow both prescribers and patients access to a much-needed safe and cost-effective licensed oral liquid formulation when required.”

First of Its Kind

The approved product, based on the brand Tapclob, is notable for being the first oral liquid suspension form of clobazam to receive regulatory approval. Originally launched in May 2013 under the Tapclob brand, this formulation has been developed to provide a user-friendly medication alternative, particularly beneficial for pediatric use in treating epilepsy as an adjunctive therapy.

Product Specifications and Usage

Epaclob and Silocalm are available in two strengths: 5mg/5ml and 10mg/5ml, catering to diverse dosing requirements. The products are packaged with dosing syringes and dosage caps to ensure accurate dosing, enhancing treatment effectiveness and safety. This packaging innovation reflects Martindale Pharma’s dedication to improving patient care and treatment outcomes.

The expansion of Epaclob and Silocalm across multiple European countries is a testament to Martindale Pharma’s robust product development and regulatory strategy. By addressing the need for more accessible pediatric formulations, the company not only enhances its market presence but also significantly contributes to better healthcare outcomes in the field of epilepsy treatment.