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Molecule

Eptinezumab

Calcitonin Gene-related Peptide Antagonist
Available on requestBiologicCold chainPain and anaesthesia
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Eptinezumab is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults. It is available as injection for intravenous use. MedsAcross supplies Eptinezumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Calcitonin Gene-related Peptide Antagonist, Calcitonin Gene-related Peptide Antagonists
ATC classification
N02CD Antimigraine, subgroup N02CD · Antimigraine
US FDA first approval
21 February 2020
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravenous
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 8202AY8I7HCAS 1644539-04-7DrugBank DB14040Q28208949

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults

Source: US FDA prescribing information

How it works

Eptinezumab-jjmr is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

Source: US FDA prescribing information

Dosing overview

Must dilute before use. For intravenous infusion only. Recommended dosage is 100 mg as an intravenous infusion over approximately 30 minutes every 3 months. Some patients may benefit from a dosage of 300 mg every 3 months. Dilute only in 100 mL of 0.9% Sodium Chloride Injection

Source: US FDA prescribing information

Contraindications

VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included anaphylaxis and angioedema. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients

Source: US FDA prescribing information

Warnings and precautions

Hypersensitivity Reactions: If a hypersensitivity reaction occurs, consider discontinuing VYEPTI and initiate appropriate therapy. Constipation with Serious Complications: Serious complications of constipation may occur. Hypertension: New-onset or worsening of pre-existing hypertension may occur. Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions. Constipation with Serious Complications Hypertension Raynaud’s Phenomenon The most common adverse reactions (≥2% and 2% or greater than placebo) were nasopharyngitis and hypersensitivity

Source: US FDA prescribing information

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze or shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Eptinezumab, sorted by availability.

MedicineManufacturerRegisterAvailability
Vyepti 100 mg/1 mL injectionIntravenous Cold chainLundbeck PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 21 February 2020Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Eptinezumab available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Eptinezumab and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Eptinezumab have?

The catalogue lists 1 brand names for Eptinezumab, including Vyepti.

Is Eptinezumab approved by the US FDA?

Yes. The US FDA first approved Eptinezumab on 21 February 2020, according to Drugs@FDA.

Is Eptinezumab authorised in the European Union?

Yes. Eptinezumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Eptinezumab need cold chain shipping?

At least one listed presentation of Eptinezumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Eptinezumab in?

Eptinezumab is classified under ATC code N02CD (Antimigraine, subgroup N02CD).

References

  1. Vyepti prescribing information (Lundbeck Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 5 June 2026
  2. Vyepti: European public assessment report (EPAR). European Medicines Agency. Retrieved 10 November 2026

Request Eptinezumab for export supply

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