MSD Animal Health Receives Positive Final Opinion from European Medicines Agency for BRAVECTO™ (fluralaner) Spot-On for Cats and Dogs
MSD Animal Health (known as Merck Animal Health in the United States and Canada) today announced that the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has adopted a positive final opinion, recommending the granting of a marketing authorization for the veterinary medicinal product BRAVECTO™ (fluralaner) Spot-On for both cats and dogs.
In 2014, BRAVECTO was launched as a chew for dogs providing protection with its active ingredient, fluralaner, against fleas and ticks for up to 12 weeks with a single treatment. BRAVECTO Spot-On provides 12 weeks of flea and tick protection for both cats and dogs with the same active ingredient as BRAVECTO chew. More than 13 million doses of BRAVECTO have been dispensed in 60 countries since its introduction.
BRAVECTO Spot-On will be the first product to provide immediate and persistent systemic flea and tick protection for cats and gives veterinarians and dog owners a choice in how to administer flea and tick protection. BRAVECTO Spot-On can be used to treat Flea Allergy Dermatitis (FAD) in dogs and also cats.
If adopted, BRAVECTO Spot-On will be indicated for the treatment of tick and flea infestations on cats and dogs. It is a systemic insecticide and acaricide that provides immediate and persistent flea (Ctenocephalides felis) killing activity for 12 weeks in cats and dogs.
Fleas and ticks must attach to the treated animal and commence feeding in order to be exposed to the active substance. The most common side effects in dogs are mild and transient skin reactions such as erythema or alopecia at the application site and, in cats, pruritus at the application site.
BRAVECTO Spot-On is applied using the company’s unique “Twist’n’Use”™ pipette design for ease of application. Detailed conditions of the product will be described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available after the marketing authorization has been granted by the European Commission.
About MSD Animal Health
For 125 years, MSD has been a global health care leader working to help the world be well. MSD Animal Health, known as Merck Animal Health in the United States and Canada, is the global animal health business unit of MSD. Through its commitment to the Science of Healthier Animals™, MSD Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. MSD Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.msd-animal-health.com or connect with us on LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2015 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
The Brightline Initiative, Project Management Institute and The Boston Consulting Group Host The Economist Events for Davos Panel19.1.2018 21:13 | Pressemelding
The Brightline™ Initiative, a non-commercial coalition dedicated to helping organizations bridge the gap between strategy design and strategy delivery, along with Project Management Institute (PMI) and The Boston Consulting Group are hosting The Economist Events on the panel discussion, “The Business Case for Openness: Implementing Strategy in a Drawbridge up World.” This event marks Brightline’s debut at Davos. Dovetailing with the World Economic Forum’s overarching theme, “Creating a Shared Future in a Fractured World,” the discussion will address how business leaders can better adapt and implement strategies to promote openness and collaboration. PMI, a founding coalition member of Brightline, is particularly passionate about this topic, given the fact that they focus on collaborating with world-leading organizations to improve infrastructure initiatives in developing and mature communities around the world. “Today the challenges to sustainable growth through strategy implementation
New US Patent for Solidia Technologies’ CO2-cured Concrete Advances Performance and Sustainability of Building Materials19.1.2018 18:07 | Pressemelding
The U.S. Patent and Trademark Office issued a patent for the structure of CO2-cured Solidia Concrete™, advancing the performance and sustainability of materials available to the global construction and materials industries. Solidia Technologies® holds the exclusive licensing rights to the patent, which is held by Rutgers University, where the original generation of the material was invented. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005608/en/ Solidia Concrete™ pavers. (Photo: Business Wire) U.S. Patent No. 9,868,667, "Bonding Element, Bonding Matrix and Composite Material Having the Bonding Element and Method of Manufacturing Thereof," covers the composition of matter of the non-hydraulic concrete. “The hydrate bonds in conventional concrete can compromise that material’s strength and durability,” explained Solidia Chief Technology Officer Nicholas DeCristofaro, Ph.D. “With CO2-cured concrete, bonding elements bas
Schlumberger Announces Full-Year and Fourth-Quarter 2017 Results19.1.2018 12:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for full-year 2017 and the fourth quarter of 2017. Full-Year Results (Stated in millions, except per share amounts) Twelve Months Ended Change Dec. 31, 2017 Dec. 31, 2016 Year-on-year Revenue $30,440 $27,810 9% Pretax operating income $3,921 $3,273 20% Pretax operating margin 12.9% 11.8% 111 bps Net loss (GAAP basis) $(1,505) $(1,687) n/m Net income, excluding charges and credits* $2,085 $1,550 35% Diluted EPS (loss per share) (GAAP basis) $(1.08) $(1.24) n/m Diluted EPS, excluding charges and credits* $1.50 $1.14 32% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Full-year 2017 revenue of $30.4 billion increased 9% year-on-year. This included a full year’s activity from the acquired Cameron businesses as compared to three quarters of activity in 2016. Excluding the addition of Cameron, revenue growth was driven by land activity in North America, which increa
The Coca-Cola Company Announces New Global Vision to Help Create a World Without Waste19.1.2018 11:55 | Pressemelding
The Coca-Cola Company announced today that it is fundamentally reshaping its approach to packaging, with a global goal to help collect and recycle the equivalent of 100% of its packaging by 2030. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005104/en/ In 2017, employees from Heartland Coca-Cola Bottling Co. joined with other volunteers in St. Louis to collect and sort 14,480 pounds of debris; 63 percent was diverted for recycling. Coca-Cola then partnered with manufacturer Phoenix Technologies to convert plastic bottles into recycled PET plastic for use in new bottles. (Photo: Business Wire) This goal is the centerpiece of the Company’s new packaging vision for a World Without Waste, which the Coca-Cola system intends to back with a multi-year investment that includes ongoing work to make packaging 100% recyclable. This begins with the understanding that food and beverage containers are an important part of people’s m
Researchers and Scientists from Five Countries Named Winners of King Faisal Prize 201819.1.2018 10:33 | Pressemelding
Five researchers and scientists from Malaysia, Jordan, Tunisia, the US and the UK have been named winners of the King Faisal Prize 2018 as the 40th edition of the renowned award recognized their distinguished contributions towards humanity. The Prize honours exceptional achievements in five categories: Service to Islam, Islamic Studies, Arabic Language & Literature, Medicine, and Science. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005245/en/ His Royal Highness Prince Khalid Al-Faisal, Chairman of King Faisal Prize Board, Abdulaziz (Photo: AETOSWire) Professor Irwandi Jaswir, Deputy Dean of the International Institute for Halal Research and Training (INHART) and Secretary of Council of Professors at the International Islamic University Malaysia (IIUM), has been named the winner in the Service to Islam category for contributions to the development of ‘Halal Science’ and Halal food and consumer goods. Professor Bashar
E.ON Chooses Corinex Broadband over Powerline Technology for their Smart Metering Rollout19.1.2018 06:00 | Pressemelding
E.ON, an international energy company that serves 32 million customers across multiple countries, has decided to use broadband over powerline (BPL) as the key technology in their communication mix, in the smart metering communication infrastructure for the low voltage part of their grid. E.ON chose Corinex as the solution provider for the initial two years of the deployment. The initial deployment will be several ten thousands of repeaters and head ends providing secure communication for a couple of hundred thousands of households. Corinex Grid Value network management based on IBM Tivoli platform will manage the network. “After extensive field trials, we found that Corinex broadband over powerline technology meets our requirements for mass rollout of smart metering services. We are convinced BPL is ideally suited to address the needs of many other utilities, so E.ON is interested in supporting BPL industry standardization in order to create a broad ecosystem of silicon and system vend
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom