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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