Medicine
ENTYVIO Pen 108 mg/0.68 mL injection
ENTYVIO Pen 108 mg/0.68 mL injection is a prescription medicine containing Vedolizumab for subcutaneous use, marketed by Takeda Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Refrigerate ENTYVIO unopened vials, prefilled syringes, and prefilled pens at…
Key facts
- Active ingredient (INN)
- Vedolizumab
- Brand
- ENTYVIO Pen
- Strength
- 108 mg/0.68 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 tray of 0.68 mL
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Refrigerate ENTYVIO unopened vials, prefilled syringes, and prefilled pens at 2°C to 8°C (36° to 46°F). If needed, the ENTYVIO prefilled syringe or ENTYVIO PEN can be left out of the refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AA33 Vedolizumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 September 2023
- Identifiers
- RxCUI 1538137, 1538142, 2667332 +3DailyMed set ID 6e94621c-1a95-4af9-98d1-52b9e6f1949cNDC 64764-108Application BLA761133
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tray in 1 carton / 1 syringe in 1 tray / .68 mL in 1 syringe | 64764-108-21 | Takeda Pharmaceuticals | 27 September 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Vedolizumab 108 mg/0.68 mL injection.
Other strengths and forms of Vedolizumab
Clinical summary
Vedolizumab is an integrin receptor antagonist indicated in adults for the treatment of moderately to severely active ulcerative colitis (UC). It is available as injection and powder for injection for subcutaneous and intravenous use. MedsAcross supplies Vedolizumab 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
Read about VedolizumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ENTYVIO prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Entyvio: European public assessment report (EPAR) · European Medicines Agency
Need ENTYVIO Pen 108 mg/0.68 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.