Tag: Notice
Summary Basis of Reconsideration Decision (SBRD) Reconsideration of a Notice of Non-Compliance Withdrawal
Summary Basis of Reconsideration Decision – Reconsideration of a Notice of Non-Compliance Withdrawal Health Canada RSS – Drug Products, Drugs and Health Products
Notice – Update: Registration and Disclosure of Clinical Trial Information
Update – An updated Notice dated 2012-10-19, on ongoing activities related to registration and disclosure of clinical trials has been posted. Health Canada RSS – Drug Products, Drugs and Health Products
Notice of Decision for MEDTRONIC COREVALVE® SYSTEM
Health Canada Notice of Decision October 9, 2012. Medtronic CoreValve System, Medtronic Corevalve LLC. Application number: 174668, licence number: 89391. Health Canada RSS – Drug Products, Drugs and Health Products
Notice of Decision for TREANDA
Health Canada Notice of Decision October 9, 2012. Treanda, bendamustine hydrochloride, 25 mg/vial and 100 mg.vial, powder, Lundbeck Canada Inc.. Submission Control Number: 149814 Health Canada RSS – Drug Products, Drugs and Health Products
Notice of Decision for REMOVAB
Health Canada Notice of Decision September 6, 2012. Removab, catumaxomab, 0.1 mg/mL solution Fresenius Biotech GmbH Submission Control Number: 142629 Health Canada RSS – Drug Products, Drugs and Health Products
Notice to Stakeholders: Foreign Sites – Expiring; Change to Expiry Calculation
In order to maintain a valid foreign site, DEL holders must submit an amendment application along with full and complete GMP evidence at least 250 days before the expiry of the foreign site. Effective immediately, Health Canada is changing how periods of validity/expiry dates are calculated and assigned to GMP foreign site evidence as currently [...]
Notice of Decision for INLYTA
Health Canada Notice of Decision August 16, 2012 . Inlyta, axitinib, 1 mg and 5 mg, tablets, Pfizer Products Inc. Submission Control Number: 144404 Health Canada RSS – Drug Products, Drugs and Health Products
Notice – Health Products and Food Branch (HPFB) International Regulatory Forum 2012
Health Canada’s Health Products and Food Branch (HPFB) is pleased to offer our fourth International Regulatory Forum (IRF) in Ottawa, Canada from September 24-28, 2012. The 2012 Forum will provide a detailed overview of the Canadian regulatory process for health products, throughout the pre- and post-market product life cycle. Health Canada RSS – Drug Products, [...]
Notice – Health Products and Food Branch (HPFB) International Regulatory Forum 2012
Health Canada’s Health Products and Food Branch (HPFB) is pleased to offer our fourth International Regulatory Forum (IRF) in Ottawa, Canada from September 24-28, 2012. The 2012 Forum will provide a detailed overview of the Canadian regulatory process for health products, throughout the pre- and post-market product life cycle. Health Canada RSS – Drug Products, [...]
Notice – 2012 Annual Drug Notification and Fee Remission Request
Please note that in order to process the fee remission request, companies must ensure that the Right to Sell Drugs Fee Remission Request and Attestation Form includes required information. Health Canada RSS – Drug Products, Drugs and Health Products
