- Funding
- Agenda of the COMP meeting 3-5 December 2024
- Minutes of the COMP meeting 3-5 December 2024
- Agenda of the COMP meeting 21-23 January 2025
- Heading and text to be inserted in Section 5.1 of the SmPC
- Minimum inhibitory concentration (MIC) breakpoints
- Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin
- Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 26 February 2025
- How to recognise scams using EMA credentials
- Minutes of the CVMP meeting 14-15 January 2025
- Orphan designation: Rilzabrutinib Treatment of autoimmune haemolytic anaemia, 16/01/2025 Positive
- Orphan designation: Clofutriben Treatment of Cushing's syndrome of endogenous origin, 16/01/2025 Positive
- Orphan designation: xevinapant Treatment of ovarian cancer, 11/11/2015 Withdrawn
- Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene (etuvetidigene autotemcel) Treatment of Wiskott-Aldrich syndrome, 07/10/2013 Withdrawn
- Orphan designation: amitriptyline Treatment of erythromelalgia, 21/06/2022 Withdrawn
- Know Which Medication Is Right for Your Seasonal Allergies
- Sani-Care Salon Products, Inc. - 673747 - 04/24/2024
- Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
- Report | Drug Shortages: Root Causes and Potential Solutions
- FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
- Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
- Modernizing the New Drugs Regulatory Program
- FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
- Public Workshop: Best Practices for Meeting Management Under PDUFA VII - 07/22/2024
- Center for Drug Evaluation and Research National Survey on Numerical Claims in Prescription Drug Advertising
- Infla-650 contains hidden drug ingredients
- Cefdinir - Oral products
- Considerations in Demonstrating Interchangeability With a Reference Product: Update
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- FDA updates guidance on interchangeability
- Class 3 Medicines Recall: Glucophage SR 500 mg, 750mg and 1000mg Prolonged-release Tablets, EL(25)A/07
- Field Safety Notices: 10th - 14th February 2025
- Field Safety Notices: 3 to 7 February 2025
- Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg, EL(25)A/06
- Class 2 Medicines Recall: Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules, EL(25)A/05
- Field Safety Notices: 27 to 31 January 2025
- Class 2 Medicines Recall: Bristol Laboratories Limited, Amlodipine Bristol Lab 2.5 mg Tablets, EL (25)A/04
- Field Safety Notices: 20 to 24 January 2025
- Class 2 Medicines Recall: Tesco Health Dry Cough Relief 200ml, Asda Strong Dry Tickly Cough 200ml, Almus Dry Cough Relief & Bells Dual Action Dry Cough, EL(25)A/03
- Field Safety Notices: 13 to 17 January 2025
- Field Safety Notices: 21 to 25 August 2023
- Field Safety Notices: 19 to 23 June 2023
- Field Safety Notices: 6 to 10 January 2025
- Class 4 Medicines Notification: Irbesartan 150 mg and 300 mg film-coated tablets, EL(25)A/02
- Class 4 Medicines Notification: Rabeprazole sodium 10mg and 20mg gastro-resistant tablets, EL(25)A/01
FDA
- Know Which Medication Is Right for Your Seasonal Allergies
- Sani-Care Salon Products, Inc. - 673747 - 04/24/2024
- Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
- Report | Drug Shortages: Root Causes and Potential Solutions
- FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
- Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
- Modernizing the New Drugs Regulatory Program
- FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
- Public Workshop: Best Practices for Meeting Management Under PDUFA VII - 07/22/2024
- Center for Drug Evaluation and Research National Survey on Numerical Claims in Prescription Drug Advertising
- Infla-650 contains hidden drug ingredients
- Cefdinir - Oral products
- Considerations in Demonstrating Interchangeability With a Reference Product: Update
- Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
- FDA updates guidance on interchangeability
