Medicine
TISSEEL Fibrin Sealant 86.5 mg/500 IU per mL topical solution
TISSEEL Fibrin Sealant 86.5 mg/500 IU per mL topical solution is a prescription medicine containing Fibrinogen human and Human thrombin for topical use, marketed by Baxter Healthcare, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Storage as on the product label
Key facts
- Active ingredient (INN)
- Fibrinogen human and Human thrombin
- Brand
- TISSEEL Fibrin Sealant
- Strength
- 86.5 mg/500 IU per mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 2 mL, 4 mL, 10 mL
- Marketing authorisation holder
- Baxter Healthcare
- Manufacturer
- Baxter Healthcare
- Origin register
- US FDA, United States
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 1998
- Identifiers
- NDC 0338-9564, 0338-9568, 0338-9560Application BLA103980
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 |
|---|---|---|---|
| 2 mL in 1 syringe, plastic | 0338-9560-01 | Baxter Healthcare | 1 May 1998 |
| 4 mL in 1 syringe, plastic | 0338-9564-01 | Baxter Healthcare | 1 May 1998 |
| 10 mL in 1 syringe, plastic | 0338-9568-01 | Baxter Healthcare | 1 May 1998 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
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
Other strengths and forms of Fibrinogen human and Human thrombin
Clinical summary
Fibrinogen human and Human thrombin is a fixed-dose combination medicine indicated with manual compression in adult, among other approved uses. It is available as topical solution and patches. MedsAcross supplies Fibrinogen human and Human thrombin 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 Fibrinogen human and Human thrombinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- US FDA NDC directory · Checked 12 November 2026
- TachoSil prescribing information (Corza Medical) · U.S. National Library of Medicine, DailyMed
Need TISSEEL Fibrin Sealant 86.5 mg/500 IU per mL topical solution 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.