Request for clinical documents of Xolair (Genentech Inc.)

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Request

I’d like to request clinical documents of Xolair (Genentech, Inc.).

Please provide protocols, statistical analysis plans, and clinical study reports of below studies:

1. Phase 3 studies in urticaria patients (Sponsor Protocol Numbers: Q4882g, Q4881g, and Q4883g).
2. Phase 2 studies in urticaria patients (Sponsor Protocol numbers: CQGE031C2302, and Q4577g).
3. Bioequivalence studies for prefilled syringe (sponsor Protocol number: C2101 and A2204).

Outcome

Information not held.

Response

This information may be held by the Medicines and Healthcare products Regulation Agency (MHRA) and is therefore not held at The National Archives.

Please contact the MHRA to request a review of this information. We will not be forwarding your request so you will need to contact them directly at:

MHRA Freedom of Information Team
10 South Colonnade
London E14 4PU
United Kingdom
info@mhra.gov.uk