Date: 2017-11-14
Type of information: Granting of a Market Authorisation in the EU
Product name: VeraSeal®
Compound: human fibrinogen / human thrombin
Therapeutic area:
Action mechanism:
- protein. When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin. The fibrin then aggregates and forms a fibrin clot that helps the wound to heal, preventing bleeding.
Company: Grifols (Spain)
Disease: use as a sealant during surgical operations in adults
Latest news:
- • On September 14, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for VeraSeal® (human fibrinogen / human thrombin), intended for use as a sealant during surgical operations in adults. VeraSeal® will be available as solutions containing the active substances human
fibrinogen (80 mg/ml) and human thrombin (500 IU/ml).
The benefits of VeraSeal® are its ability to help the wound to heal, preventing bleeding. The most common side effects are procedural pain, nausea, pruritus and pyrexia.
The full indication is: "Supportive treatment in adults where standard surgical techniques are insufficient:
• for improvement of haemostasis.
• as suture support in vascular surgery."
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-11-14
Favourable opinion UE: 2017-09-14
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes