Labeling
The labeling module manages all regulatory labeling artefacts including SmPCs, PILs, US Prescribing Information, and IFUs across all markets. Labeling artefacts are linked to the statements library, change history, and submission sequences.
Labeling: 87IFU: 56PIL: 73SmPC: 84
| ID | Product | Market | Type | Version | Language | Statements | Status | Last Reviewed |
|---|---|---|---|---|---|---|---|---|
| LBL-001 | Ocluvance | US | Labeling | 8.3 | ko | 13 | Approved | 2024-07-05 |
| LBL-002 | Verasol | EU | Labeling | 1.2 | de | 7 | Approved | 2024-03-10 |
| LBL-003 | Cardivex | JP | Labeling | 7.8 | nl | 3 | Active | 2023-10-21 |
| LBL-004 | Nepricor | CN | Labeling | 19.9 | en | 15 | Pending | 2023-08-11 |
| LBL-005 | Immuvance | BR | Labeling | 1.2 | pt | 3 | In Progress | 2023-06-21 |
| LBL-006 | Duplexan | CA | IFU | 12.4 | en | 14 | Pending | 2023-12-01 |
| LBL-007 | Neuraclair | AU | PIL | 15.5 | it | 5 | Pending | 2023-06-24 |
| LBL-008 | Alzaclear | GB | PIL | 15.0 | sv | 11 | Approved | 2024-02-21 |
| LBL-009 | Raredex | CH | SmPC | 5.9 | de | 3 | In Progress | 2023-10-11 |
| LBL-010 | Fabricor | DE | Labeling | 3.0 | nl | 11 | Submitted | 2024-06-15 |
| LBL-011 | Infeclear | FR | IFU | 10.5 | sv | 6 | In Progress | 2023-09-28 |
| LBL-012 | Respimax | IT | SmPC | 14.6 | ko | 15 | Active | 2023-09-26 |
| LBL-013 | Tiotropex | ES | IFU | 15.3 | en | 9 | Approved | 2023-05-29 |
| LBL-014 | Glucovex | NL | PIL | 3.3 | pt | 12 | Pending | 2023-06-26 |
| LBL-015 | Haemovance | KR | IFU | 3.6 | pl | 15 | In Progress | 2023-06-26 |
| LBL-016 | Retinacor | TW | Labeling | 9.6 | zh | 15 | In Progress | 2023-12-23 |
| LBL-017 | Thymomax | SG | IFU | 14.5 | es | 6 | Approved | 2023-06-10 |
| LBL-018 | Pancrexan | IN | Labeling | 19.3 | es | 4 | In Progress | 2023-11-19 |
| LBL-019 | Brexivance | MX | PIL | 16.4 | nl | 3 | Active | 2024-03-01 |
| LBL-020 | Erenvex | AR | SmPC | 14.8 | nl | 15 | Approved | 2024-07-06 |
| LBL-021 | Lorlacor | TR | IFU | 8.1 | ko | 13 | Submitted | 2023-09-07 |
| LBL-022 | Sacuvance | SA | Labeling | 18.1 | nl | 9 | Active | 2023-11-21 |
| LBL-023 | Upadvex | ZA | SmPC | 16.4 | pt | 11 | Approved | 2023-09-30 |
| LBL-024 | Semaglumax | RU | SmPC | 2.0 | pl | 11 | Approved | 2024-05-23 |
| LBL-025 | Tisavance | PL | IFU | 19.8 | pl | 10 | In Progress | 2024-07-12 |
| LBL-026 | Ozanemax | SE | PIL | 20.2 | fr | 11 | In Progress | 2023-07-27 |
| LBL-027 | Lecavance | BE | PIL | 17.7 | de | 6 | In Progress | 2023-05-21 |
| LBL-028 | Crizomax | AT | SmPC | 8.6 | fr | 15 | Approved | 2024-03-01 |
| LBL-029 | Atezovance | PT | Labeling | 9.5 | es | 8 | Pending | 2023-12-15 |
| LBL-030 | Mavacor | DK | PIL | 5.4 | it | 9 | Approved | 2024-03-01 |
| LBL-031 | Ocluvance | US | SmPC | 17.0 | zh | 15 | In Progress | 2023-11-19 |
| LBL-032 | Verasol | EU | Labeling | 5.4 | ko | 8 | Pending | 2024-07-02 |
| LBL-033 | Cardivex | JP | SmPC | 9.0 | es | 4 | Pending | 2023-11-07 |
| LBL-034 | Nepricor | CN | IFU | 1.9 | sv | 8 | Pending | 2024-01-02 |
| LBL-035 | Immuvance | BR | Labeling | 13.4 | zh | 8 | Submitted | 2023-06-21 |
| LBL-036 | Duplexan | CA | Labeling | 13.9 | ko | 5 | Approved | 2024-06-19 |
| LBL-037 | Neuraclair | AU | IFU | 7.8 | sv | 15 | Pending | 2024-04-21 |
| LBL-038 | Alzaclear | GB | SmPC | 7.4 | sv | 12 | Submitted | 2023-11-14 |
| LBL-039 | Raredex | CH | PIL | 13.4 | nl | 9 | Pending | 2023-07-10 |
| LBL-040 | Fabricor | DE | IFU | 19.3 | fr | 6 | In Progress | 2024-04-08 |
| LBL-041 | Infeclear | FR | PIL | 16.2 | de | 6 | Submitted | 2023-09-07 |
| LBL-042 | Respimax | IT | PIL | 3.0 | sv | 14 | Approved | 2024-05-22 |
| LBL-043 | Tiotropex | ES | SmPC | 9.6 | nl | 5 | Pending | 2024-04-28 |
| LBL-044 | Glucovex | NL | PIL | 11.9 | nl | 11 | Pending | 2023-12-11 |
| LBL-045 | Haemovance | KR | SmPC | 14.8 | de | 4 | Pending | 2023-05-16 |
| LBL-046 | Retinacor | TW | Labeling | 14.8 | zh | 4 | Approved | 2024-04-03 |
| LBL-047 | Thymomax | SG | Labeling | 18.6 | en | 3 | Active | 2023-08-31 |
| LBL-048 | Pancrexan | IN | Labeling | 6.4 | sv | 11 | Pending | 2023-07-09 |
| LBL-049 | Brexivance | MX | PIL | 16.5 | nl | 15 | In Progress | 2023-10-23 |
| LBL-050 | Erenvex | AR | SmPC | 16.8 | nl | 6 | Active | 2023-09-21 |
| LBL-051 | Lorlacor | TR | Labeling | 10.3 | pl | 14 | In Progress | 2023-07-29 |
| LBL-052 | Sacuvance | SA | IFU | 8.8 | de | 7 | Pending | 2024-04-13 |
| LBL-053 | Upadvex | ZA | Labeling | 20.2 | en | 7 | Active | 2024-05-17 |
| LBL-054 | Semaglumax | RU | SmPC | 7.4 | ko | 11 | Submitted | 2023-07-06 |
| LBL-055 | Tisavance | PL | SmPC | 2.9 | es | 6 | Pending | 2023-05-16 |
| LBL-056 | Ozanemax | SE | Labeling | 2.3 | ja | 9 | In Progress | 2024-04-21 |
| LBL-057 | Lecavance | BE | IFU | 18.6 | it | 11 | Pending | 2024-05-02 |
| LBL-058 | Crizomax | AT | Labeling | 9.2 | pl | 13 | In Progress | 2024-04-09 |
| LBL-059 | Atezovance | PT | PIL | 1.3 | de | 13 | Approved | 2023-12-08 |
| LBL-060 | Mavacor | DK | SmPC | 9.8 | ja | 6 | Approved | 2024-02-19 |
Showing 60 of 300 artefacts