Postauthorization safety surveillance study of antihaemophilic factor (recombinant) reconstituted in 2 mL sterile water for injection in children with haemophilia A

Author:

Motwani Jayashree1,Guillet Benoit2,Blatny Jan3,Schilling Freimut H.4,Wibaut Bénédicte5,Goldstine Jimena6,Nagy Andras7,Doralt Jennifer7,Engl Werner7,Tangada Srilatha6,Spotts Gerald6

Affiliation:

1. Birmingham Children's Hospital Birmingham UK

2. IRSET Rennes University Hospital and Inserm U1085 Rennes France

3. Children's University Hospital Brno Brno Czech Republic

4. Luzerner Kantonsspital Lucerne Switzerland

5. CRTH Institut Coeur Poumon CHU Lille France

6. Baxalta US Inc., a member of the Takeda group of companies Lexington MA USA

7. Baxalta Innovations GmbH, a member of the Takeda group of companies Vienna Austria

Funder

Baxalta Innovations GmbH, a Takeda company, Vienna, Austria

Baxalta US Inc., a Takeda company, Westlake Village, CA, USA

Publisher

Wiley

Subject

Genetics(clinical),Hematology,General Medicine

Reference22 articles.

1. Anti‐hemophilic factor (recombinant), plasma/albumin‐free method (octocog‐alpha; ADVATE) in the management of hemophilia A;Shapiro AD;Vasc Health Risk Manag,2007

2. Advancing personalized care in hemophilia A: ten years’ experience with an advanced category antihemophilic factor prepared using a plasma/albumin-free method

3. European Medicines Agency.ADVATE. Summary of product characteristics.https://www.ema.europa.eu/en/documents/product‐information/advate‐epar‐product‐information_en.pdf. Accessed February 28 2019.

4. Adherence to prophylactic infusions of factor VIII or factor IX for haemophilia

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