Pregabalin Viatris (previously Pregabalin Mylan)

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Overview

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.

Pregabalin Viatris is available as capsules to be taken by mouth and can only be obtained with a prescription.

For more information about using Pregabalin Viatris, see the package leaflet or contact your doctor or pharmacist.

The active substance in Pregabalin Viatris, pregabalin, is similar in structure to the body’s own ‘neurotransmitter’ gamma‑amino butyric acid (GABA), but has very different biological effects. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells. This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Viatris.

As for every medicine, the company provided studies on the quality of Pregabalin Viatris. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Because Pregabalin Viatris is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The European Medicines Agency concluded that, in accordance with EU requirements, Pregabalin Viatris has been shown to have comparable quality and to be bioequivalent to Lyrica. Therefore, the Agency’s view was that, as for Lyrica, the benefits of Pregabalin Viatris outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Lyrica also apply to Pregabalin Viatris where appropriate.

As for all medicines, data on the use of Pregabalin Viatris are continuously monitored. Suspected side effects reported with Pregabalin Viatris are carefully evaluated and any necessary action taken to protect patients.

Pregabalin Mylan received a marketing authorisation valid throughout the EU on 25 June 2015.

The name of the medicine was changed to Pregabalin Viatris on 24 July 2024.

English (EN)
(176.53 KB – PDF)

First published: 31/07/2015Last updated: 08/01/2025

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English (EN)
(103.79 KB – PDF)

First published: 31/07/2015Last updated: 03/09/2015

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Product information

English (EN)
(325.11 KB – PDF)

First published: 31/07/2015Last updated: 06/03/2025

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Latest procedure affecting product information:
VR/0000252315

06/03/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(41.33 KB – PDF)

First published: 31/07/2015Last updated: 11/09/2024

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Product details

Name of medicine

Pregabalin Viatris (previously Pregabalin Mylan)

Active substance

pregabalin

International non-proprietary name (INN) or common name

pregabalin

Therapeutic area (MeSH)

Anxiety Disorders
Epilepsy

Anatomical therapeutic chemical (ATC) code

N02BF02

Pharmacotherapeutic group

Antiepileptics

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.

More information on Pregabalin Mylan

English (EN)
(66.45 KB – PDF)

First published: 09/07/2007Last updated: 07/12/2012

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Pregabalin Viatris (previously Pregabalin Mylan)

Overview

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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Pregabalin Viatris (previously Pregabalin Mylan)

Overview

How is Pregabalin Viatris used?

How does Pregabalin Viatris work?

How has Pregabalin Viatris been studied?

What are the benefits and risks of Pregabalin Viatris?

Why is Pregabalin Viatris authorised in the EU?

What measures are being taken to ensure the safe and effective use of Pregabalin Viatris?

Other information about Pregabalin Viatris

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

More information on Pregabalin Mylan

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