Variations
The variation register tracks all post-approval regulatory variations across the product portfolio. Type IA/IB/II classification (EU), Major/Minor (US), submission dates, approval timelines, and associated fees are maintained for each variation filing.
Minor: 99Major: 86Type IA: 112Type IB: 92Type II: 111
| Variation # | Change | Application | Type | Description | Fee | Status | Submitted | Approved |
|---|---|---|---|---|---|---|---|---|
| FDA-2024-0001-V001 | CHG-001 | FDA-2024-0001 | Minor | Minor variation: Specification Change for Kcluximab — m… | €1,982 | Overdue | 2024-04-28 | — |
| EMA-2023-0002-V002 | CHG-002 | EMA-2023-0002 | Major | Major variation: Labeling Change for Verasenib — routin… | €28,226 | Failed | 2024-02-05 | — |
| PMDA-2022-0003-V003 | CHG-003 | PMDA-2022-0003 | Minor | Minor variation: Analytical Method Change for Cardilost… | €3,373 | Failed | 2023-08-04 | — |
| NMPA-2021-0004-V004 | CHG-004 | NMPA-2021-0004 | Type IA | Type IA variation: Formulation Change for Neprilozone —… | €2,338 | Active | — | — |
| ANVISA-2020-0005-V005 | CHG-005 | ANVISA-2020-0005 | Type IA | Type IA variation: Container Closure Change for Immunov… | €4,793 | Submitted | 2023-03-10 | — |
| HC-2024-0006-V006 | CHG-006 | HC-2024-0006 | Major | Major variation: New Dosage Strength for Dupitumacon — … | €35,108 | Approved | — | 2024-06-29 |
| TGA-2023-0007-V007 | CHG-007 | TGA-2023-0007 | Minor | Minor variation: Specification Change for Neuravastatin… | €4,749 | Completed | 2023-04-24 | — |
| MHRA-2022-0008-V008 | CHG-008 | MHRA-2022-0008 | Type IA | Type IA variation: New Dosage Strength for Alzabistat —… | €1,676 | In Progress | 2023-06-10 | — |
| SwissMedic-2021-0009-V009 | CHG-009 | SwissMedic-2021-0009 | Type IB | Type IB variation: New Dosage Strength for Raredimab — … | €3,507 | Active | 2024-01-18 | — |
| MFDS-2020-0010-V010 | CHG-010 | MFDS-2020-0010 | Type IA | Type IA variation: Formulation Change for Fabrizyme-β —… | €669 | Failed | 2024-01-29 | — |
| TFDA-2024-0011-V011 | CHG-011 | TFDA-2024-0011 | Type IB | Type IB variation: Manufacturing Process Change for Inf… | €2,976 | Approved | — | 2024-03-29 |
| HSA-2023-0012-V012 | CHG-012 | HSA-2023-0012 | Type IA | Type IA variation: Labeling Change for Respiralimab — m… | €1,446 | Overdue | — | — |
| CDSCO-2022-0013-V013 | CHG-013 | CDSCO-2022-0013 | Type II | Type II variation: Storage Condition Change for Tiotrop… | €25,811 | Overdue | — | — |
| COFEPRIS-2021-0014-V014 | CHG-014 | COFEPRIS-2021-0014 | Type IB | Type IB variation: New Dosage Strength for Glucovantib … | €4,333 | Completed | 2023-11-24 | — |
| ANMAT-2020-0015-V015 | CHG-015 | ANMAT-2020-0015 | Type IA | Type IA variation: Storage Condition Change for Haemofe… | €4,046 | Blocked | 2024-06-18 | — |
| TITCK-2024-0016-V016 | CHG-016 | TITCK-2024-0016 | Type IB | Type IB variation: Manufacturing Process Change for Ret… | €3,332 | Draft | — | — |
| SFDA-2023-0017-V017 | CHG-017 | SFDA-2023-0017 | Type IA | Type IA variation: Facility Change for Thymosilib — maj… | €2,338 | Active | — | — |
| SAHPRA-2022-0018-V018 | CHG-018 | SAHPRA-2022-0018 | Minor | Minor variation: Formulation Change for Pancrelipaze-R … | €2,403 | Approved | 2024-02-23 | 2023-11-06 |
| Roszdravnadzor-2021-0019-V019 | CHG-019 | Roszdravnadzor-2021-0019 | Type II | Type II variation: Labeling Change for Brextanib — crit… | €12,359 | Submitted | 2023-05-12 | — |
| MOH-IL-2020-0020-V020 | CHG-020 | MOH-IL-2020-0020 | Type II | Type II variation: Analytical Method Change for Erenuma… | €13,328 | Blocked | 2023-07-22 | — |
| FDA-2024-0021-V021 | CHG-021 | FDA-2024-0021 | Minor | Minor variation: Shelf Life Extension for Lorlatenilib … | €3,627 | Failed | 2022-08-29 | — |
| EMA-2023-0022-V022 | CHG-022 | EMA-2023-0022 | Type II | Type II variation: Storage Condition Change for Sacubit… | €11,065 | Submitted | 2023-12-08 | — |
| PMDA-2022-0023-V023 | CHG-023 | PMDA-2022-0023 | Minor | Minor variation: Manufacturing Process Change for Upada… | €3,435 | Pending | 2023-02-05 | — |
| NMPA-2021-0024-V024 | CHG-024 | NMPA-2021-0024 | Major | Major variation: New Dosage Strength for Semaglutidex —… | €65,217 | Failed | — | — |
| ANVISA-2020-0025-V025 | CHG-025 | ANVISA-2020-0025 | Type IA | Type IA variation: Analytical Method Change for Tisagen… | €4,908 | In Progress | — | — |
| HC-2024-0026-V026 | CHG-026 | HC-2024-0026 | Type IA | Type IA variation: Facility Change for Ozanemolistat — … | €4,771 | Blocked | 2024-02-05 | — |
| TGA-2023-0027-V027 | CHG-027 | TGA-2023-0027 | Type IA | Type IA variation: Storage Condition Change for Lecanem… | €1,035 | Active | — | — |
| MHRA-2022-0028-V028 | CHG-028 | MHRA-2022-0028 | Minor | Minor variation: Analytical Method Change for Crizotina… | €4,565 | Submitted | 2024-05-28 | — |
| SwissMedic-2021-0029-V029 | CHG-029 | SwissMedic-2021-0029 | Type II | Type II variation: Container Closure Change for Atezoli… | €37,770 | Failed | 2022-08-18 | — |
| MFDS-2020-0030-V030 | CHG-030 | MFDS-2020-0030 | Type II | Type II variation: Analytical Method Change for Mavacam… | €35,371 | Completed | 2023-04-04 | — |
| TFDA-2024-0031-V031 | CHG-031 | TFDA-2024-0031 | Major | Major variation: New Dosage Strength for Kcluximab — cr… | €52,919 | Completed | 2023-06-16 | — |
| HSA-2023-0032-V032 | CHG-032 | HSA-2023-0032 | Type II | Type II variation: Storage Condition Change for Verasen… | €69,273 | Draft | — | — |
| CDSCO-2022-0033-V033 | CHG-033 | CDSCO-2022-0033 | Major | Major variation: New Dosage Strength for Cardilostat — … | €71,519 | In Progress | 2023-10-01 | — |
| COFEPRIS-2021-0034-V034 | CHG-034 | COFEPRIS-2021-0034 | Minor | Minor variation: Shelf Life Extension for Neprilozone —… | €3,255 | Overdue | 2024-02-28 | — |
| ANMAT-2020-0035-V035 | CHG-035 | ANMAT-2020-0035 | Minor | Minor variation: Facility Change for Immunovant-α — cri… | €4,106 | Approved | 2023-11-20 | 2024-02-09 |
| TITCK-2024-0036-V036 | CHG-036 | TITCK-2024-0036 | Type IA | Type IA variation: Labeling Change for Dupitumacon — ro… | €2,167 | In Progress | 2022-12-20 | — |
| SFDA-2023-0037-V037 | CHG-037 | SFDA-2023-0037 | Major | Major variation: Storage Condition Change for Neuravast… | €63,113 | Failed | 2023-08-18 | — |
| SAHPRA-2022-0038-V038 | CHG-038 | SAHPRA-2022-0038 | Type IB | Type IB variation: New Dosage Strength for Alzabistat —… | €4,313 | Completed | 2024-02-12 | — |
| Roszdravnadzor-2021-0039-V039 | CHG-039 | Roszdravnadzor-2021-0039 | Type IB | Type IB variation: Storage Condition Change for Raredim… | €1,455 | Blocked | — | — |
| MOH-IL-2020-0040-V040 | CHG-040 | MOH-IL-2020-0040 | Minor | Minor variation: Shelf Life Extension for Fabrizyme-β —… | €1,961 | Submitted | 2023-04-24 | — |
| FDA-2024-0041-V041 | CHG-041 | FDA-2024-0041 | Type IB | Type IB variation: Storage Condition Change for Infecti… | €1,921 | Overdue | 2024-02-25 | — |
| EMA-2023-0042-V042 | CHG-042 | EMA-2023-0042 | Type IA | Type IA variation: Labeling Change for Respiralimab — r… | €538 | Completed | 2024-02-04 | — |
| PMDA-2022-0043-V043 | CHG-043 | PMDA-2022-0043 | Minor | Minor variation: New Dosage Strength for Tiotropizone —… | €3,019 | In Progress | 2023-04-17 | — |
| NMPA-2021-0044-V044 | CHG-044 | NMPA-2021-0044 | Major | Major variation: Storage Condition Change for Glucovant… | €58,523 | Overdue | 2024-02-25 | — |
| ANVISA-2020-0045-V045 | CHG-045 | ANVISA-2020-0045 | Type IB | Type IB variation: Analytical Method Change for Haemofe… | €1,531 | Pending | 2023-02-12 | — |
| HC-2024-0046-V046 | CHG-046 | HC-2024-0046 | Type IB | Type IB variation: Analytical Method Change for Retinav… | €2,440 | Blocked | 2022-08-03 | — |
| TGA-2023-0047-V047 | CHG-047 | TGA-2023-0047 | Minor | Minor variation: Container Closure Change for Thymosili… | €4,528 | Submitted | — | — |
| MHRA-2022-0048-V048 | CHG-048 | MHRA-2022-0048 | Minor | Minor variation: Analytical Method Change for Pancrelip… | €4,079 | Blocked | 2022-11-27 | — |
| SwissMedic-2021-0049-V049 | CHG-049 | SwissMedic-2021-0049 | Major | Major variation: Formulation Change for Brextanib — maj… | €34,086 | Failed | 2023-03-17 | — |
| MFDS-2020-0050-V050 | CHG-050 | MFDS-2020-0050 | Type IA | Type IA variation: New Dosage Strength for Erenumabix —… | €1,919 | Approved | 2023-01-27 | 2024-04-10 |
| TFDA-2024-0051-V051 | CHG-051 | TFDA-2024-0051 | Type II | Type II variation: Container Closure Change for Lorlate… | €54,297 | Failed | — | — |
| HSA-2023-0052-V052 | CHG-052 | HSA-2023-0052 | Type IB | Type IB variation: Storage Condition Change for Sacubit… | €656 | Failed | — | — |
| CDSCO-2022-0053-V053 | CHG-053 | CDSCO-2022-0053 | Minor | Minor variation: Facility Change for Upadacitimab — min… | €2,378 | Active | — | — |
| COFEPRIS-2021-0054-V054 | CHG-054 | COFEPRIS-2021-0054 | Type IA | Type IA variation: Formulation Change for Semaglutidex … | €4,358 | Overdue | 2023-01-11 | — |
| ANMAT-2020-0055-V055 | CHG-055 | ANMAT-2020-0055 | Minor | Minor variation: New Dosage Strength for Tisagenlecleux… | €2,607 | Completed | — | — |
| TITCK-2024-0056-V056 | CHG-056 | TITCK-2024-0056 | Minor | Minor variation: Manufacturing Process Change for Ozane… | €955 | Submitted | 2022-12-11 | — |
| SFDA-2023-0057-V057 | CHG-057 | SFDA-2023-0057 | Type IB | Type IB variation: Labeling Change for Lecanemabix — ro… | €1,196 | Active | 2023-05-11 | — |
| SAHPRA-2022-0058-V058 | CHG-058 | SAHPRA-2022-0058 | Major | Major variation: Container Closure Change for Crizotina… | €57,213 | Draft | 2022-09-08 | — |
| Roszdravnadzor-2021-0059-V059 | CHG-059 | Roszdravnadzor-2021-0059 | Type II | Type II variation: New Dosage Strength for Atezolimumab… | €17,508 | Draft | 2022-08-24 | — |
| MOH-IL-2020-0060-V060 | CHG-060 | MOH-IL-2020-0060 | Minor | Minor variation: Manufacturing Process Change for Mavac… | €3,681 | Overdue | 2022-10-06 | — |
| FDA-2024-0061-V061 | CHG-061 | FDA-2024-0061 | Major | Major variation: Analytical Method Change for Kcluximab… | €57,886 | Approved | 2022-12-11 | 2024-04-27 |
| EMA-2023-0062-V062 | CHG-062 | EMA-2023-0062 | Type IB | Type IB variation: Labeling Change for Verasenib — crit… | €4,715 | In Progress | 2024-04-09 | — |
| PMDA-2022-0063-V063 | CHG-063 | PMDA-2022-0063 | Major | Major variation: Labeling Change for Cardilostat — mino… | €79,178 | Draft | 2023-01-17 | — |
| NMPA-2021-0064-V064 | CHG-064 | NMPA-2021-0064 | Type IB | Type IB variation: Labeling Change for Neprilozone — mi… | €3,923 | Failed | — | — |
| ANVISA-2020-0065-V065 | CHG-065 | ANVISA-2020-0065 | Major | Major variation: Formulation Change for Immunovant-α — … | €21,122 | Blocked | 2023-04-22 | — |
| HC-2024-0066-V066 | CHG-066 | HC-2024-0066 | Type IB | Type IB variation: Specification Change for Dupitumacon… | €2,255 | Active | 2022-12-31 | — |
| TGA-2023-0067-V067 | CHG-067 | TGA-2023-0067 | Type IB | Type IB variation: Container Closure Change for Neurava… | €1,121 | Failed | 2024-06-02 | — |
| MHRA-2022-0068-V068 | CHG-068 | MHRA-2022-0068 | Minor | Minor variation: Labeling Change for Alzabistat — criti… | €814 | Submitted | 2022-09-08 | — |
| SwissMedic-2021-0069-V069 | CHG-069 | SwissMedic-2021-0069 | Major | Major variation: Storage Condition Change for Raredimab… | €22,913 | Submitted | 2023-08-14 | — |
| MFDS-2020-0070-V070 | CHG-070 | MFDS-2020-0070 | Type IA | Type IA variation: Container Closure Change for Fabrizy… | €977 | Failed | 2022-11-01 | — |
| TFDA-2024-0071-V071 | CHG-071 | TFDA-2024-0071 | Type II | Type II variation: Shelf Life Extension for Infectivir … | €11,284 | Overdue | 2023-02-06 | — |
| HSA-2023-0072-V072 | CHG-072 | HSA-2023-0072 | Type II | Type II variation: Storage Condition Change for Respira… | €11,493 | Blocked | 2023-06-21 | — |
| CDSCO-2022-0073-V073 | CHG-073 | CDSCO-2022-0073 | Type IA | Type IA variation: Analytical Method Change for Tiotrop… | €1,753 | Pending | — | — |
| COFEPRIS-2021-0074-V074 | CHG-074 | COFEPRIS-2021-0074 | Type IA | Type IA variation: Formulation Change for Glucovantib —… | €825 | In Progress | 2022-12-01 | — |
| ANMAT-2020-0075-V075 | CHG-075 | ANMAT-2020-0075 | Type II | Type II variation: Analytical Method Change for Haemofe… | €59,507 | In Progress | 2023-12-31 | — |
| TITCK-2024-0076-V076 | CHG-076 | TITCK-2024-0076 | Minor | Minor variation: Formulation Change for Retinavab — min… | €4,160 | Draft | 2023-02-04 | — |
| SFDA-2023-0077-V077 | CHG-077 | SFDA-2023-0077 | Type IB | Type IB variation: Specification Change for Thymosilib … | €3,845 | Overdue | 2023-09-18 | — |
| SAHPRA-2022-0078-V078 | CHG-078 | SAHPRA-2022-0078 | Type II | Type II variation: Storage Condition Change for Pancrel… | €25,664 | Completed | — | — |
| Roszdravnadzor-2021-0079-V079 | CHG-079 | Roszdravnadzor-2021-0079 | Type II | Type II variation: New Dosage Strength for Brextanib — … | €43,813 | Draft | — | — |
| MOH-IL-2020-0080-V080 | CHG-080 | MOH-IL-2020-0080 | Minor | Minor variation: Labeling Change for Erenumabix — criti… | €3,827 | In Progress | — | — |
Showing 80 of 500 variations