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Sep 30, 2015

Mylan Launches Generic Lamot® (Lamotrigine) Tablets

16 October, 2014

Mylan Launches Generic Lamot® (Lamotrigine) Tablets

DUBLIN and PITTSBURGH, 01 October 2014 -- Mylan Inc. (NASDAQ: MYL) today announced the Irish launch of Lamot (Lamotrigine) 25 mg, 50 mg, 100 mg and 200 mg Tablets, which is the generic version of GSK's Lamictal® (Lamotrigine) Tablets. Mylan received final approval from the Irish Health Products Regulatory Authority (HPRA) for this product, which is indicated for the treatment of Epilepsy and Bipolar Disorder.
Lamotrigine 25 mg, 50 mg, 100 mg and 200 mg Tablets had Irish sales of approximately 96,187 packs for the 12 months ending July 2014, according to IMS Health. Legal Category:
>Available on prescription only.
Marketing Authorisation Number:

PA 577/77/1-4

Marketing Authorisation Holder:

McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Full Prescribing Information available on request from:

Mylan Centre of Excellence Dublin, Mylan Ireland Limited, Newenham Court, Northern Cross, Malahide Road, Dublin 17. Tel: 01-8322250

Read carefully the instructions on the leaflet contained within the package.

Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;  Tel:  +353 1 6764971 Fax: + 353 1 6762517. Website: www.hpra.ie E-mail: medsafety@hpra.ie. Adverse events should also be reported to Medical Information, Mylan Building 4 - Trident Place, Hatfield Business Park, Mosquito Way, Hatfield, Hertfordshire, AL10 9BW, phone no: 01707 853000, Email: info@mylan.co.uk

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 around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.ie and mylan.com.




Last Updated:  30/09/2015