Changes
The change management register tracks all post-approval product changes from initiation through impact assessment, variation filing, and regulatory completion. Each change specifies the impacted markets, dossier modules, and labeling artefacts.
| Change # | Product | Type | Description | Markets | Modules | Variations | Status | Owner | Initiated |
|---|---|---|---|---|---|---|---|---|---|
| CHG-2024-0001 | Ocluvance | Analytical Method Change | Specification Change for Kcluximab — minor update… | 2 | 4.2.1, 3.2.P.3 | 1 | Draft | Priya Sharma | 2023-06-20 |
| CHG-2023-0002 | Verasol | Container Closure Change | Labeling Change for Verasenib — routine update… | 2 | 3.2.P.3, 2.3.P, 4.2.1 | 4 | Overdue | Dmitri Volkov | 2023-12-16 |
| CHG-2022-0003 | Cardivex | Specification Change | Analytical Method Change for Cardilostat — routine… | 8 | 2.3.P | 4 | Pending | Dmitri Volkov | 2022-05-29 |
| CHG-2021-0004 | Nepricor | Shelf Life Extension | Formulation Change for Neprilozone — major revisio… | 3 | 2.3.P, 3.2.S, 3.2.P.3 | 3 | Draft | Lieselotte van der Berg | 2022-08-01 |
| CHG-2024-0005 | Immuvance | Shelf Life Extension | Container Closure Change for Immunovant-α — routin… | 7 | 3.2.P.3 | 5 | Draft | Nadia Petrova | 2022-07-19 |
| CHG-2023-0006 | Duplexan | Specification Change | New Dosage Strength for Dupitumacon — major revisi… | 8 | 5.3.5, 3.2.P.3, 4.2.1, 3.2.P | 5 | Failed | Sarah Chen | 2022-03-31 |
| CHG-2022-0007 | Neuraclair | Facility Change | Specification Change for Neuravastatin — major rev… | 7 | 2.3.P, 3.2.S, 4.2.1 | 4 | Failed | Priya Sharma | 2023-09-22 |
| CHG-2021-0008 | Alzaclear | Storage Condition Change | New Dosage Strength for Alzabistat — major revisio… | 2 | 3.2.P.3, 3.2.S, 5.3.5, 2.3.P | 2 | Pending | Carlos Mendez | 2023-01-11 |
| CHG-2024-0009 | Raredex | Specification Change | New Dosage Strength for Raredimab — minor update… | 2 | 3.2.P | 1 | Failed | Tomoko Ikeda | 2023-04-08 |
| CHG-2023-0010 | Fabricor | Facility Change | Formulation Change for Fabrizyme-β — critical chan… | 3 | 2.3.P, 3.2.S | 4 | Draft | Lieselotte van der Berg | 2023-12-09 |
| CHG-2022-0011 | Infeclear | Labeling Change | Manufacturing Process Change for Infectivir — crit… | 7 | 3.2.S, 3.2.P, 4.2.1 | 5 | Draft | Sarah Chen | 2023-12-28 |
| CHG-2021-0012 | Respimax | New Dosage Strength | Labeling Change for Respiralimab — major revision… | 8 | 3.2.S, 2.3.P, 3.2.P | 4 | Blocked | Marcus Webb | 2022-07-06 |
| CHG-2024-0013 | Tiotropex | Facility Change | Storage Condition Change for Tiotropizone — critic… | 3 | 5.3.5 | 1 | Pending | Sarah Chen | 2024-03-10 |
| CHG-2023-0014 | Glucovex | Formulation Change | New Dosage Strength for Glucovantib — major revisi… | 4 | 4.2.1, 2.3.P | 2 | Active | James O'Brien | 2022-08-28 |
| CHG-2022-0015 | Haemovance | New Dosage Strength | Storage Condition Change for Haemoferrin — critica… | 1 | 3.2.P.3, 2.3.P, 3.2.P, 4.2.1 | 1 | Overdue | Priya Sharma | 2024-02-26 |
| CHG-2021-0016 | Retinacor | Storage Condition Change | Manufacturing Process Change for Retinavab — minor… | 5 | 2.3.P, 3.2.P, 5.3.5 | 4 | Blocked | James O'Brien | 2023-12-21 |
| CHG-2024-0017 | Thymomax | Storage Condition Change | Facility Change for Thymosilib — major revision… | 8 | 3.2.P, 3.2.S, 2.3.P | 2 | Draft | Nadia Petrova | 2022-08-04 |
| CHG-2023-0018 | Pancrexan | Storage Condition Change | Formulation Change for Pancrelipaze-R — critical c… | 8 | 3.2.P, 3.2.S, 3.2.P.3, 4.2.1 | 5 | Draft | Priya Sharma | 2022-12-22 |
| CHG-2022-0019 | Brexivance | Container Closure Change | Labeling Change for Brextanib — critical change… | 7 | 3.2.P, 3.2.S | 5 | In Progress | Lieselotte van der Berg | 2023-02-06 |
| CHG-2021-0020 | Erenvex | Facility Change | Analytical Method Change for Erenumabix — routine … | 2 | 3.2.P.3, 5.3.5 | 1 | Failed | Nadia Petrova | 2023-08-04 |
| CHG-2024-0021 | Lorlacor | Labeling Change | Shelf Life Extension for Lorlatenilib — minor upda… | 8 | 5.3.5, 4.2.1, 3.2.S | 1 | Draft | Sarah Chen | 2022-01-25 |
| CHG-2023-0022 | Sacuvance | Labeling Change | Storage Condition Change for Sacubitrivex — critic… | 7 | 2.3.P, 3.2.P.3 | 2 | Approved | Aisha Okonkwo | 2023-03-28 |
| CHG-2022-0023 | Upadvex | Labeling Change | Manufacturing Process Change for Upadacitimab — mi… | 7 | 3.2.P | 3 | Approved | Marcus Webb | 2022-05-07 |
| CHG-2021-0024 | Semaglumax | Formulation Change | New Dosage Strength for Semaglutidex — major revis… | 3 | 3.2.S | 2 | Overdue | Sarah Chen | 2023-03-02 |
| CHG-2024-0025 | Tisavance | Shelf Life Extension | Analytical Method Change for Tisagenlecleux-B — mi… | 6 | 3.2.S, 4.2.1, 5.3.5 | 2 | Draft | Tomoko Ikeda | 2022-02-12 |
| CHG-2023-0026 | Ozanemax | Analytical Method Change | Facility Change for Ozanemolistat — minor update… | 8 | 5.3.5 | 2 | Overdue | Tomoko Ikeda | 2023-08-03 |
| CHG-2022-0027 | Lecavance | Labeling Change | Storage Condition Change for Lecanemabix — critica… | 6 | 2.3.P, 3.2.S | 1 | In Progress | Carlos Mendez | 2022-03-04 |
| CHG-2021-0028 | Crizomax | Storage Condition Change | Analytical Method Change for Crizotinabex — routin… | 5 | 3.2.P, 4.2.1, 2.3.P | 5 | Approved | Nadia Petrova | 2023-10-08 |
| CHG-2024-0029 | Atezovance | New Dosage Strength | Container Closure Change for Atezolimumab-R — rout… | 5 | 5.3.5, 3.2.P.3 | 3 | Approved | Lieselotte van der Berg | 2022-04-03 |
| CHG-2023-0030 | Mavacor | Manufacturing Process Change | Analytical Method Change for Mavacamtamex — routin… | 2 | 5.3.5 | 5 | Approved | Sarah Chen | 2023-12-14 |
| CHG-2022-0031 | Ocluvance | Formulation Change | New Dosage Strength for Kcluximab — critical chang… | 2 | 5.3.5, 3.2.P.3, 4.2.1 | 2 | In Progress | James O'Brien | 2022-12-18 |
| CHG-2021-0032 | Verasol | New Dosage Strength | Storage Condition Change for Verasenib — major rev… | 8 | 4.2.1 | 5 | Overdue | Nadia Petrova | 2023-04-01 |
| CHG-2024-0033 | Cardivex | Formulation Change | New Dosage Strength for Cardilostat — major revisi… | 7 | 3.2.P, 4.2.1, 5.3.5, 3.2.S | 5 | Active | Carlos Mendez | 2022-12-19 |
| CHG-2023-0034 | Nepricor | Analytical Method Change | Shelf Life Extension for Neprilozone — major revis… | 3 | 2.3.P, 4.2.1 | 3 | Overdue | James O'Brien | 2022-06-14 |
| CHG-2022-0035 | Immuvance | Formulation Change | Facility Change for Immunovant-α — critical change… | 6 | 5.3.5, 3.2.P | 2 | Submitted | Marcus Webb | 2022-12-24 |
| CHG-2021-0036 | Duplexan | Storage Condition Change | Labeling Change for Dupitumacon — routine update… | 4 | 4.2.1 | 4 | Completed | Carlos Mendez | 2023-11-25 |
| CHG-2024-0037 | Neuraclair | Storage Condition Change | Storage Condition Change for Neuravastatin — minor… | 7 | 3.2.S, 4.2.1, 3.2.P | 4 | Failed | Dmitri Volkov | 2022-10-23 |
| CHG-2023-0038 | Alzaclear | Shelf Life Extension | New Dosage Strength for Alzabistat — routine updat… | 1 | 3.2.P.3, 4.2.1 | 2 | Failed | Nadia Petrova | 2023-10-14 |
| CHG-2022-0039 | Raredex | Facility Change | Storage Condition Change for Raredimab — routine u… | 7 | 3.2.P, 2.3.P, 4.2.1, 3.2.S | 5 | Failed | Aisha Okonkwo | 2022-09-30 |
| CHG-2021-0040 | Fabricor | Shelf Life Extension | Shelf Life Extension for Fabrizyme-β — critical ch… | 6 | 2.3.P | 2 | Pending | Carlos Mendez | 2022-08-27 |
| CHG-2024-0041 | Infeclear | New Dosage Strength | Storage Condition Change for Infectivir — minor up… | 2 | 3.2.P, 3.2.P.3, 3.2.S, 4.2.1 | 1 | Pending | Nadia Petrova | 2022-12-05 |
| CHG-2023-0042 | Respimax | Storage Condition Change | Labeling Change for Respiralimab — routine update… | 1 | 2.3.P, 3.2.P.3, 5.3.5 | 3 | Draft | James O'Brien | 2022-08-16 |
| CHG-2022-0043 | Tiotropex | Specification Change | New Dosage Strength for Tiotropizone — critical ch… | 8 | 3.2.S, 5.3.5, 3.2.P.3, 4.2.1 | 5 | Pending | Dmitri Volkov | 2022-07-10 |
| CHG-2021-0044 | Glucovex | Container Closure Change | Storage Condition Change for Glucovantib — routine… | 8 | 3.2.S, 3.2.P.3 | 5 | Approved | Marcus Webb | 2022-11-19 |
| CHG-2024-0045 | Haemovance | Manufacturing Process Change | Analytical Method Change for Haemoferrin — major r… | 8 | 2.3.P, 3.2.P, 4.2.1 | 5 | Active | Dmitri Volkov | 2022-10-14 |
| CHG-2023-0046 | Retinacor | Formulation Change | Analytical Method Change for Retinavab — minor upd… | 8 | 5.3.5 | 3 | Completed | Tomoko Ikeda | 2022-04-23 |
| CHG-2022-0047 | Thymomax | Container Closure Change | Container Closure Change for Thymosilib — routine … | 3 | 3.2.S, 3.2.P, 2.3.P | 2 | Pending | Nadia Petrova | 2023-03-05 |
| CHG-2021-0048 | Pancrexan | Container Closure Change | Analytical Method Change for Pancrelipaze-R — rout… | 4 | 2.3.P, 5.3.5, 3.2.P.3 | 1 | Active | Marcus Webb | 2023-11-25 |
| CHG-2024-0049 | Brexivance | Shelf Life Extension | Formulation Change for Brextanib — major revision… | 4 | 3.2.P.3, 2.3.P | 3 | Submitted | James O'Brien | 2022-10-13 |
| CHG-2023-0050 | Erenvex | Labeling Change | New Dosage Strength for Erenumabix — major revisio… | 5 | 5.3.5, 3.2.S, 3.2.P.3, 4.2.1 | 4 | Failed | Aisha Okonkwo | 2023-09-09 |
| CHG-2022-0051 | Lorlacor | Manufacturing Process Change | Container Closure Change for Lorlatenilib — critic… | 3 | 3.2.P.3 | 3 | Pending | Nadia Petrova | 2022-03-27 |
| CHG-2021-0052 | Sacuvance | New Dosage Strength | Storage Condition Change for Sacubitrivex — critic… | 8 | 2.3.P | 1 | Overdue | Lieselotte van der Berg | 2023-12-07 |
| CHG-2024-0053 | Upadvex | Formulation Change | Facility Change for Upadacitimab — minor update… | 8 | 2.3.P | 2 | Submitted | Marcus Webb | 2023-11-03 |
| CHG-2023-0054 | Semaglumax | Container Closure Change | Formulation Change for Semaglutidex — minor update… | 8 | 3.2.P.3 | 5 | Overdue | Lieselotte van der Berg | 2022-02-23 |
| CHG-2022-0055 | Tisavance | Facility Change | New Dosage Strength for Tisagenlecleux-B — routine… | 8 | 4.2.1 | 3 | Approved | Aisha Okonkwo | 2023-12-29 |
| CHG-2021-0056 | Ozanemax | Shelf Life Extension | Manufacturing Process Change for Ozanemolistat — m… | 3 | 2.3.P, 5.3.5, 3.2.S, 4.2.1 | 1 | In Progress | Carlos Mendez | 2022-06-15 |
| CHG-2024-0057 | Lecavance | Specification Change | Labeling Change for Lecanemabix — routine update… | 1 | 3.2.P.3, 5.3.5, 4.2.1 | 4 | Completed | Lieselotte van der Berg | 2023-08-05 |
| CHG-2023-0058 | Crizomax | Storage Condition Change | Container Closure Change for Crizotinabex — critic… | 5 | 2.3.P, 5.3.5, 3.2.P.3 | 3 | Pending | Aisha Okonkwo | 2022-03-08 |
| CHG-2022-0059 | Atezovance | Specification Change | New Dosage Strength for Atezolimumab-R — critical … | 3 | 3.2.S | 4 | Active | Aisha Okonkwo | 2023-12-22 |
| CHG-2021-0060 | Mavacor | Specification Change | Manufacturing Process Change for Mavacamtamex — ro… | 6 | 4.2.1, 3.2.P.3 | 5 | Submitted | James O'Brien | 2023-04-14 |
Showing 60 of 300 changes