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EMA Product

Pregabalin Viatris (previously Pregabalin Mylan)

Product approved by European Medicines Agency (EU)

Basic Information

Pregabalin Viatris (previously Pregabalin Mylan)

Regulatory Information

EMEA/H/C/004078

Authorised

June 24, 2015

April 22, 2015

22

March 6, 2025

Company Information

Ireland

Damastown Industrial Park Mulhuddart Dublin 15

VIATRIS PHARMA LIMITED

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication **Neuropathic pain** Pregabalin Viatris is indicated for the treatment of peripheral and central neuropathic pain in adults. **Epilepsy** Pregabalin Viatris is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. **Generalised Anxiety Disorder** Pregabalin Viatris is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Overview Summary

Pregabalin Viatris is a medicine used to treat adults with the following conditions: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury; • epilepsy, where it is used as an ‘add-on’ to other epilepsy treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain); • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters). Pregabalin Viatris contains the active substance pregabalin and is a ‘generic medicine’. This means that Pregabalin Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Pregabalin Viatris is Lyrica. For more information on generic medicines, see the question-and-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).

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