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23-Jul-2019

Mylan becomes the Marketing Authorisation Holder for TOBI Podhaler® and TOBI Solution® (INN) in the UK

22 July 2019 – Mylan today announced that, after positive opinion from the Committee on Human Medicinal Products (CHMP), the European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have granted the marketing authorisation transfer to Mylan for TOBI Podhaler® and TOBI Solution® in the UK for patients with Cystic Fibrosis.

TOBI Podhaler® and TOBI Solution®

Mylan received final pan-European approval through a centralised procedure for the transfer of TOBI Podhaler® (tobramycin inhalation powder, 28mg per capsule) on 28 June 2019 and nationally for TOBI Solution® (tobramycin, 300mg/5ml for nebulisation) on 5 June 2019.

TOBI Podhaler® and TOBI Solution® are indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with Cystic Fibrosis.[1],[2]

The recommended dose for TOBI Podhaler® is 112 mg tobramycin (4 x 28 mg capsules), administered twice daily for 28 days. The recommended dose for TOBI Solution® is one ampoule twice daily for 28 days. TOBI is taken in alternating cycles of 28 days on treatment followed by 28 days off treatment.

Mylan’s commitment to patients with Cystic Fibrosis

The marketing authorisation of TOBI Podhaler® and TOBI Solution® is welcomed and demonstrates Mylan’s commitment to those with Cystic Fibrosis.

Cystic Fibrosis is one of the EU’s most common life-shortening inherited diseases, affecting over 44,000 people. [3] With improvements in diagnosis and care, life expectancy is increasing swiftly, and CF has become a disease of adults3 with 52.4% of CF patients aged over 18.3

In the UK, around 10,500 people have Cystic Fibrosis, a condition which for many involves a rigorous daily treatment regime including physiotherapy, oral, nebulised and occasionally intravenous antibiotics, and taking enzyme tablets with food. 4 

Jose Cotarelo, Area Director, Northern Europe commented: “We’re very pleased that Mylan becomes the Marketing Authorisation Holder for TOBI Podhaler® and TOBI Solution®. Mylan have continually supported the Cystic Fibrosis community and as treatments improve, patients are living longer. It is imperative therefore, that we continue to develop care regimes that improve patients’ quality of life.”

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine. You should also report any side effects to Mylan UK Pharmacovigilance on +44 (0)800 121 8267 or ukpharmacovigilance@mylan.com

Resources

TOBI® Podhaler® 28mg inhalation powder, hard capsules – Patient Leaflet and SmPC

TOBI® 300mg/5ml Nebuliser Solution – Patient Leaflet and SmPC


[1] Summary of Product Characteristics: TOBI Podhaler 28 mg inhalation powder. Available at: https://www.ema.europa.eu/en/documents/product-information/tobi-podhaler-epar-product-information_en.pdf

[2] https://www.medicines.org.uk/emc/product/262

[3] European Cystic Fibrosis Society: Facts and Figures 2016. Available at: https://www.ecfs.eu/sites/default/files/general-content-files/working-groups/ecfs-patient-registry/CF1006_At_A_Glance_Guide_2016.pdf [Last accessed June 2019]

4 https://www.cysticfibrosis.org.uk

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Last Updated: 23-Jul-2019