A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding.
The main endpoints are:
1. Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death.
2. Administration feasibility of FC within the prehospital setting.
Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.

Start Date01 Jan 2025

Sponsor / Collaborator-

CTRI/2024/09/073878

/ Not yet recruitingNot ApplicableIIT

Evaluation of the effect of fibrinogen on peripartum hemorrhage in Placenta accreta spectrum (PAS) disorders, a double blind randomized controlled trial. - NIL

Start Date24 Sep 2024

Sponsor / Collaborator-

NCT05449834

/ RecruitingPhase 3IIT

Fibrinogen Early In Severe Trauma StudY II

Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes.
Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis.
Fibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities.
The timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage.
FEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate

Start Date21 Nov 2022

Sponsor / Collaborator

Australian and New Zealand Intensive Care Research Centre

[+2]

100 Clinical Results associated with Fibrinogen Concentrate (Human)

100 Translational Medicine associated with Fibrinogen Concentrate (Human)

100 Patents (Medical) associated with Fibrinogen Concentrate (Human)

538

Literatures (Medical) associated with Fibrinogen Concentrate (Human)

01 Feb 2026·INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA

Acute obstetric coagulopathy without severe postpartum haemorrhage following medical termination of pregnancy presenting as gingival bleeding: a case report

Article

Author: Dhadda, A ; Metodiev, Y ; Thomas, G

Postpartum haemorrhage is a leading cause of maternal morbidity and mortality worldwide - rarely this is complicated by coagulopathy. Our understanding of the mechanisms of acute obstetric coagulopathy remains uncertain. This report aims to highlight the importance of its early recognition, diagnosis and management. We report a case of acute obstetric coagulopathy potentially exacerbating postpartum haemorrhage following medical termination of pregnancy at 23 weeks gestation. We describe an unusual clinical presentation with gingival bleeding and evidence of hyperfibrinolysis beyond that of previously described cases. Despite the extreme coagulation abnormalities, the clinical situation did not proceed to severe postpartum haemorrhage owing to early suspicion and recognition of acute obstetric coagulopathy, as well as targeted treatment with fibrinogen concentrate and antifibrinolytics. The patient developed mild acute kidney injury which recovered spontaneously prior to discharge. This case highlights the need for better understanding of acute obstetric coagulation and its underlying mechanisms. This specific coagulation disorder has been described relatively recently for the first time and has never been reported in patients undergoing a medical termination of pregnancy in the second trimester. Further research is needed to improve our understanding on its mechanisms and triggers to potentially inform optimal management.

01 Nov 2025·TRANSFUSION

Survey of cryoprecipitate production and cryoprecipitate and fibrinogen concentrate utilization in North America: Variable practices observed from July 2016 to June 2021, The BEST Collaborative Study

Article

Author: Poisson, Jessica L. ; Grandoni, Jessica ; Shih, Andrew W. ; Vassallo, Ralph ; Young, Pampee ; Singh, Umesh ; Raval, Jay S. ; Dunbar, Nancy M. ; Germain, Marc ; Ziman, Alyssa ; Jacquot, Cyril ; Cohn, Claudia ; Lu, Wen

Abstract:

Background:

Cryoprecipitated antihemophiliac factor (cryo) is primarily used to replenish fibrinogen in acquired coagulopathy. Little has been reported about its usage patterns within hospitals with respect to patient population, frequency of use, and dosing.

Study design and methods:

Cryo production and usage data were collected over 5 years from July 1, 2016, to June 30, 2021, from nationally based blood collection centers in the United States (U.S. n = 2) and Canada ( n = 2) and from eight large academic hospitals, respectively. Usage data for a similar product, purified fibrinogen concentrate were also collected from four hospitals.

Results:

Two U.S. blood collectors reported increases in cryo production normalized to total whole blood collections from 17.4% in 2016 to 22.3% in 2021 and from 16.4% in 2016 to 20.2% in 2021. In contrast, in Canada cryo manufacturing increased slightly in one region (11.3%–12.9%) and decreased (8.0%–2.0%) in the other. Cryo utilization, defined as numbers of patients treated normalized to the inpatient census, and dose administered per patient did not consistently increase and differed significantly between hospitals participating in the study ( p < .0001). Likewise, the departments that most frequently transfused cryo varied between hospitals. Similarly, variations in practice were observed for fibrinogen concentrate usage.

Conclusion:

While much of Canada and Europe have moved towards using fibrinogen concentrate, two large U.S. collectors have increased cryo distribution. The lack of standardization and variability in the clinical practice regarding the use of cryo and fibrinogen concentrate reported by study sites may be attributable to practitioner preference, availability, and/or cost rather than adherence to published evidence or guidelines.

01 Nov 2025·JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA

Dose-Dependent Changes in Clot Firmness in Thromboelastometry After Administration of Fibrinogen Concentrate: A Retrospective Observational Study

Article

Author: Fassl, Jens ; Labus, Jakob ; Vander Zwaag, Stanislaw ; Kukel, Imre ; Towarek-Nocon, Kinga ; Taghizadeh-Waghefi, Ali

INTRODUCTION:

Viscoelastic point-of-care diagnostics are crucial in cardiac surgery. In the FIBTEM assay of rotational thromboelastometry (ROTEM), guidelines suggest target maximum clot firmness values to reduce perioperative bleeding. The fibrinogen doses required to meet these targets remain unclear. This study analyzed the dose-response relationship between fibrinogen concentrate (FC) and clot strength at 5 minutes (A5) and assessed the predictive value of A5 for postoperative hypofibrinogenemia.

DESIGN:

Single-center retrospective observational study.

SETTING:

Tertiary academic cardiac hospital.

PARTICIPANTS:

180 cardiac patients operated on between May 31, 2022, and August 31, 2024.

INTERVENTIONS:

Patients underwent 2 intraoperative ROTEM examinations and received coagulation factors.

MEASUREMENTS AND MAIN RESULTS:

Linear regression was used to examin the relationship between the FC dose and A5 changes. Receiver operating characteristic curves assessed the value of A5 in predicting hypofibrinogenemia and bleeding. Weight-based and estimated blood volume-based FC dosing closely correlated with A5 changes. Each 10 mg/kg increase in FC increased A5 by a mean of 1.37 mm (95% confidence interval [CI], 1.12-1.53 mm) for total body weight, 1.20 mm (95% CI, 1.08-1.33 mm) for ideal body weight, and 1.02 mm (95% CI, 0.9-1.13 mm) for lean body weight, as well as 8.857 mm (95% CI, 7.910-9.818 mm) per mg per mL of estimated blood volume. A5 ≤12 mm predicted hypofibrinogenemia (sensitivity, 77%; specificity, 94%). No thresholds predicted excessive blood loss.

CONCLUSIONS:

Body weight-based fibrinogen dosing allows predictions of the mean changes in A5. Total, ideal, and lean body weights yielded similar correlation coefficients.

News (Medical) associated with Fibrinogen Concentrate (Human)

14 Feb 2024

·www.fiercepharma.com

Grifols readies US, EU approval push for blood clot treatment after phase 3 success

BT524 can be administered to “patients on the operating table immediately," Grifols explained. Grifols is readying an approval run at U.S. and European regulators on the back of a phase 3 win for the Spanish plasma medicine producer's concentrated form of a blood clotting factor. The product, dubbed BT524, is a concentrated form of fibrinogen, a glycoprotein that is essential for blood clot formation and stops excessive bleeding resulting from injuries or surgery. Grifols was testing BT524 in a late-stage study of patients with acquired fibrinogen deficiency (AFD), which it described as an “underserved growth market.” The Barcelona, Spain-based company announced this morning that the product had met the study’s primary endpoint, demonstrating its noninferiority to standard of care when it came to reducing blood loss in patients with AFD who underwent spinal or abdominal surgery, while also “maintaining an excellent safety profile.” Specifically, mean blood loss was 1,444 mL among the BT524 cohort compared with 1,735 mL among patients who received standard of care. It meant patients receiving Grifols’ product lost an average of 291 mL less blood. AFD usually occurs during surgery when a patient’s body contains insufficient fibrinogen to arrest bleeding. It is typically treated with a plasma extract called cryoprecipitate or fresh frozen plasma, which both contain fibrinogen. However, both of these treatment options contain various other unneeded proteins and elements, meaning that large volumes are required to ensure the patient receives sufficient fibrinogen, Grifols explained in the release. They also need to be thawed before use, which is not only time-consuming but can put patients’ lives at risk, the company added. In contrast, BT524 can be administered to “patients on the operating table immediately,” who will only receive the fibrinogen necessary to prevent hemorrhaging, Grifols explained. The company’s plan is to kick off the approval process in both Europe and the U.S. in the fourth quarter of the year. If successful, it would mark the first fibrinogen concentrate approved for AFD in the U.S., Grifols noted. “The positive results for fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” Grifols’ chief operating officer, Victor Grifols Deu, said in the release. While Grifols has its eye on the first fibrinogen concentrate approval for AFD in the U.S., its competitors have had more luck getting their own versions to market for congenital fibrinogen deficiency. CSL Behring got RiaSTAP approved in that indication as far back as 2009, while Switzerland’s Octapharma followed suit with Fibryga in 2017. Since then, Fibryga has also received approval to treat AFD across Europe off the back of a phase 2 study. Meanwhile, Grifols is in the midst of an ongoing legal battle with Gotham City Research after the New York hedge fund accused the company of wrongful accounting practices.

Drug ApprovalClinical ResultPhase 3Phase 2

11 Jun 2021

·www.biospace.com

Fibrinogen Concentrate Market Size to Reach USD 4.19 Billion in 2028, Says Reports and Data

Increasing preference for fibrinogen concentrate over fresh-frozen plasma, rising incidence of bleeding disorders, and increasing number of fibrinogen product approvals are some key factors driving market growth Market Size – USD 2.61 Billion in 2020, Market Growth – at a CAGR of 6.1%, Market Trends – Rising R&D investment to accelerate development of advanced fibrinogen products The global fibrinogen concentrate market size is expected to reach USD 4.19 Billion in 2028 at a CAGR of 6.1%, according to the latest report by Reports and Data. Increasing R&D activities to develop new therapies for bleeding disorders, rising demand for fibrinogen concentrates to treat congenital deficiencies, and high incidence of bleeding disorders across the globe are key factors expected to drive market revenue growth over the forecast period. In addition, increasing number of advanced and innovative in pipeline to treat bleeding disorders is also expected to contribute to revenue growth of the market going ahead. Fibrinogen concentrate is a lyophilized and purified human plasma fibrinogen and is widely used as an alternative to traditional sources of fibrinogen, which is a natural blood protein playing a vital role in coagulation process. Fibrinogen concentrate has been extensively used and recommended for bleeding disorders and acquired coagulation disorders in several countries across the globe as it significantly improves blood clot firmness and minimizes the need for postoperative transfusion. Fibrinogen concentrate can either be plasma-derived or a recombinant and is often used for afibrinogenemia and dysfibrinogenemia. Increasing research is being carried out across the globe to expand its application scope to use it for conditions such as hemorrhage resuscitation. This is expected to contribute to revenue growth of the market going ahead. New product launches and approvals of fibrinogen concentrates are also expected to be a key factor driving market growth. In addition, increasing focus of key players on developing advanced fibrinogen concentrates to treat bleeding disorders is also a key market growth driving factor. However, adverse reactions associated with fibrinogen concentrate such as arterial thrombosis, dyspnea, nausea, and others are expected to hamper market growth to a certain extent over the forecast period. Access Free sample PDF Copy of the Report @ Some Key Highlights from the Report: Human fibrinogen type segment is expected to account for largest revenue share in the global market over the forecast period owing to increasing need for fibrinogen concentrate to treat bleeding disorders and congenital coagulation deficiencies. Congenital fibrinogen deficiency segment is expected to register robust revenue CAGR over the forecast period owing to high incidence of hemophilia, rising rate of bleeding disorders, proven safety and efficiency of fibrinogen concentrates and rapid advancements in fibrinogen products. North America is expected to dominate other regional markets over the forecast period owing to increasing geriatric population and high rate of bleeding disorders, advancements in diagnostics and therapeutics, and robust presence of key players in the region. Major companies in the market include CSL Behring, Baxter, Johnson & Johnson (Ethicon), LFB Group, ProFibrix BV (The Medicines Company), Shanghai RAAS, Jiangxi Boya Bio-Pharmaceutical, Hualan Biological Engineering, Harbin Pacific Biopharmaceutical, and Greencross. In November 2019, Octapharma AG announced approval for use of fibryga, which is a lyophilised human fibrinogen concentrate for intravenous infusion, in treatment of acquired fibrinogen deficiency in 15 European countries. Buy now your Exclusive copy of Report @ For the purpose of this report, Reports and Data has segmented the global fibrinogen concentrate market on the basis of type, application type, and region: Type Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) Human Animal Application Type Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) Congenital Fibrinogen Deficiency Surgical Procedures Request for Custom Research @ Regional Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) North America U.S. Canada Mexico Europe Germany U.K. France Italy BENELUX Rest of APAC Asia Pacific China India Japan South Korea Rest of APAC Latin America Brazil Rest of Latin America Middle East & Africa U.A.E. Saudi Arabia South Africa Rest of MEA Explore Reports and Data's Prime Analysis of the global Pharmaceutical & Healthcare Industry: Hemostasis Analyzers Market Analysis, By Product (Laboratory analyzer, POC testing,) By Test Type (Prothrombin Time, Fibrinogen, Activated Partial and others) By Technology Type (Mechanical and others) By End-Use (Diagnostic Centers, Hospitals, and others), Forecasts to 2026 Product (Revenue, USD Million; 2016-2026) Bovine Blood Plasma Derivatives Market Size, Share & Trends, By Type (Bovine Serum, FBS, Bovine Serum Albumin, Fibrinogen, Protein Ingredient, Others), By Application (Scientific Research, Industrial Production, Feed, Others), And Regional Forecasts To 2027 Coagulation Analyzers Market Size, Share & Analysis, By Product, By Technology (Mechanical, Electrochemical) By Test Types (APTT, D-Dimer, Fibrinogen, PT) By End Use (Hospitals, Research Institutes), And Segment, Forecasts To 2028 About Reports and Data Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target and analyze consumer behavior shifts across demographics, across industries and help client’s make a smarter business decision. We offer market intelligence studies ensuring relevant and fact-based research across a multiple industries including Healthcare, Technology, Chemicals, Power and Energy. We consistently update our research offerings to ensure our clients are aware about the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise. Contact Us: John W Head of Business Development Reports and Data | Web: Direct Line: +1-212-710-1370 E-mail: sales@reportsanddata.com Read Full Press Release:

100 Deals associated with Fibrinogen Concentrate (Human)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemorrhage	United States	CSL Behring GmbH	16 Jan 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Diseases	Phase 3	Italy	CSL Behring LLC	01 Nov 2011
Afibrinogenemia	Phase 3	-	CSL Behring LLC	01 Oct 2009
Postpartum Hemorrhage	Phase 2	-	CSL Behring LLC	01 Jan 2021
Coronary Artery Disease	Phase 2	United States	CSL Behring LLC	01 Jan 2011
Heart Valve Diseases	Phase 2	United States	CSL Behring LLC	01 Jan 2011
Aortic Aneurysm	Phase 2	Germany	CSL Behring LLC	01 Jun 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05780125 (Pubmed \| Anesth Analg)	Phase 2	-	-	FibCLOT	wrfoosrqlt(xbcvvgyyec) = plzimjibkk sgdyencdls (ghejscwjqh, 1.2)	Negative	01 Apr 2025
				RiaSTAP	wrfoosrqlt(xbcvvgyyec) = auvifsamwn sgdyencdls (ghejscwjqh, 1.6)
NCT03932240 (CTgov)	Phase 3	-	36	Fibrinogen Concentrate (FC) (Fibrinogen Concentrate (FC))	dhlfwjrdqt(udchkngqfy) = ljzwphcmlf zueodugdjy (pdbaffkuyz, oafojaqvhr - jjxpwonhaq) View more	-	20 Mar 2023
				Cryoprecipitate (Cryoprecipitate)	dhlfwjrdqt(udchkngqfy) = lneqqxboyf zueodugdjy (pdbaffkuyz, shehttzvgu - ujupnokuwh) View more
NCT02822599 (RiaSTAP, CTgov)	Phase 4	Hemorrhage \| Afibrinogenemia	30	RiaStAP (RiaSTAP)	pwkaiqnsyg(umehhwrnkx) = qqlpdnyeom fhqgpeogfh (yikabphobe, gjixfgbttb - qecmnteqgn) View more	-	16 Sep 2021
				Saline (Saline)	pwkaiqnsyg(umehhwrnkx) = vxrlolavmy fhqgpeogfh (yikabphobe, yvzawvvwfk - ontyikwubo) View more
NCT01623531 (CTgov)	Phase 3	Intraoperative Complications	62	Fibrinogen (RiaSTAP)	gntabljeeb(upsqywmwyt) = pmcxfitqna uigogijwkx (cptefoxbuy, pcpfbszrwk - elrypviumv) View more	-	22 May 2020
				Fibrinogen (Intravenous Saline)	gntabljeeb(upsqywmwyt) = nhtgaznnqy uigogijwkx (cptefoxbuy, ygjlepghjx - bhzgvqxmfz) View more
NCT01623531 (Pubmed \| Acta Anaesthesiol Scand)	Not Applicable	-	62	Fibrinogen concentrate	rwvyeypftk(vxxbigthss) = cbasrrqhde chagqmlpzd (nuinajqits )	-	01 May 2020
				Placebo	rwvyeypftk(vxxbigthss) = qerikamrlo chagqmlpzd (nuinajqits )
NCT02540434 (TOP-CLOT, CTgov)	Not Applicable	Blood Coagulation Disorders	19	RiaSTAP+ROTEM (RiaSTAP Arm)	lnnuploghk(ukvpkhqsxm) = czsanxuarp yddantedro (ypllpwfqsm, fqvcttuxhz - nrprqdwnia) View more	-	12 May 2017
				Cryoprecipitate (Cryopreciptiate Arm)	lnnuploghk(ukvpkhqsxm) = jqazstrgmx yddantedro (ypllpwfqsm, qyjokexqgg - auesrwcwtp) View more
EUCTR2009-018086-12-NL \| NCT01124981 (Pubmed \| JAMA)	Phase 2/3	Blood Loss, Surgical	120	Fibrinogen concentrate	zmcdmgbhpn(ifraitydfh) = ckbfxoenou lbgahilulb (eyfcosylax )	Negative	21 Feb 2017
				Placebo	zmcdmgbhpn(ifraitydfh) = qtybiithzx lbgahilulb (eyfcosylax )
NCT01471730 (Pubmed \| J Am Heart Assoc)	Phase 3	First line	119	Fibrinogen concentrate	civoeyhxyg(kehysgijqk) = hgxjxtezyl vgjkstydet (nffafonhnz )	Positive	02 Jun 2015
				Saline solution	civoeyhxyg(kehysgijqk) = ctpoiuorjn vgjkstydet (nffafonhnz )
NCT01283321 (RiaCT, CTgov)	Phase 2	Coronary Artery Disease \| Heart Valve Diseases	26	Human fibrinogen concentrate (Group A: RiaSTAP)	gfsoidnfzj(sjdvdezilk) = gumwyldprw zobzniduyc (xbgbzfjyzl, 0.0) View more	-	16 Feb 2015
				apheresis platelets (Group B: Apheresis Platelets)	gfsoidnfzj(sjdvdezilk) = rywhnzkvcm zobzniduyc (xbgbzfjyzl, 0.3) View more
NCT01300286 (CTgov)	Phase 4	Hemorrhage	23	RiaSTAP	wcddmeirxc(azmfzuhdsz) = auipuxdacr atkdseelku (vnchnqqqed, 49) View more	-	16 Jun 2014

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