Statements Library
The statements library is the single source of truth for all approved regulatory text statements used across labeling artefacts. Each statement carries provenance information, source reference, approval metadata, and a list of all label artefacts where it appears.
Interaction: 22PK: 31Special Population: 24Safety: 38Dosing: 29Efficacy: 20Contraindication: 36
| ID | Type | Category | Source | Provenance | Used In | Approved By | Approved | Text |
|---|---|---|---|---|---|---|---|---|
| STMT-001 | Interaction | Quality | SmPC Section 4.5 | Phase III RCT data | 1 | James O'Brien | 2023-10-20 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-002 | PK | Quality | SmPC Section 4.1 | Clinical Study KCL-001 | 1 | Carlos Mendez | 2023-12-05 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-003 | Special Population | Clinical | SmPC Section 4.1 | Clinical Study KCL-001 | 1 | Priya Sharma | 2023-11-19 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-004 | PK | Quality | Core Data Sheet | Clinical Study KCL-001 | 4 | Lieselotte van der Berg | 2024-03-19 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-005 | Safety | Quality | SmPC Section 5.1 | Clinical Study KCL-001 | 7 | Nadia Petrova | 2023-09-28 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-006 | Interaction | Nonclinical | SmPC Section 4.8 | Phase III RCT data | 1 | Nadia Petrova | 2023-04-22 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-007 | Special Population | Nonclinical | SmPC Section 5.2 | Phase III RCT data | 4 | James O'Brien | 2023-02-12 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-008 | Dosing | Safety | SmPC Section 4.4 | Clinical Study KCL-001 | 4 | James O'Brien | 2023-05-02 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… |
| STMT-009 | Dosing | Safety | Core Data Sheet | Clinical Study KCL-001 | 7 | Marcus Webb | 2023-02-15 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-010 | Interaction | Quality | SmPC Section 4.2 | Clinical Study KCL-001 | 3 | Tomoko Ikeda | 2024-05-24 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-011 | PK | Quality | SmPC Section 4.2 | Clinical Study KCL-001 | 5 | Tomoko Ikeda | 2024-04-25 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-012 | Efficacy | Clinical | Core Data Sheet | Literature review 2024 | 7 | Tomoko Ikeda | 2024-04-18 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-013 | Special Population | Clinical | SmPC Section 4.3 | Regulatory Authority guidance | 1 | Dmitri Volkov | 2024-04-25 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-014 | Contraindication | Quality | SmPC Section 4.5 | Phase III RCT data | 1 | James O'Brien | 2023-04-05 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-015 | Contraindication | Clinical | SmPC Section 5.2 | Literature review 2024 | 2 | Tomoko Ikeda | 2024-01-04 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-016 | PK | Clinical | SmPC Section 4.4 | Phase III RCT data | 5 | Priya Sharma | 2023-06-18 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-017 | Interaction | Nonclinical | SmPC Section 4.3 | Phase III RCT data | 5 | Dmitri Volkov | 2022-11-16 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-018 | Safety | Clinical | SmPC Section 4.1 | Phase III RCT data | 1 | Priya Sharma | 2022-11-06 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-019 | PK | Clinical | SmPC Section 4.3 | Expert panel consensus | 7 | Priya Sharma | 2023-09-11 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-020 | Safety | Safety | SmPC Section 4.2 | Clinical Study KCL-001 | 5 | Nadia Petrova | 2024-03-07 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-021 | Safety | Quality | Core Data Sheet | Clinical Study KCL-001 | 7 | Marcus Webb | 2023-09-07 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-022 | PK | Clinical | SmPC Section 4.2 | Regulatory Authority guidance | 7 | Sarah Chen | 2023-11-16 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-023 | Safety | Safety | Core Data Sheet | Phase III RCT data | 2 | James O'Brien | 2023-05-20 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-024 | Safety | Clinical | SmPC Section 4.5 | Regulatory Authority guidance | 4 | Nadia Petrova | 2023-05-21 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-025 | Safety | Clinical | SmPC Section 4.5 | Phase III RCT data | 2 | Dmitri Volkov | 2023-05-21 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-026 | Contraindication | Quality | SmPC Section 4.8 | Regulatory Authority guidance | 1 | Priya Sharma | 2023-06-16 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-027 | Dosing | Clinical | SmPC Section 4.5 | Clinical Study KCL-001 | 1 | Sarah Chen | 2023-04-05 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… |
| STMT-028 | PK | Clinical | SmPC Section 4.5 | Regulatory Authority guidance | 4 | Tomoko Ikeda | 2023-02-03 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-029 | Contraindication | Quality | SmPC Section 4.5 | Literature review 2024 | 7 | Dmitri Volkov | 2023-08-02 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-030 | Efficacy | Nonclinical | Core Data Sheet | Clinical Study KCL-001 | 1 | Priya Sharma | 2023-06-07 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-031 | Safety | Quality | SmPC Section 4.3 | Expert panel consensus | 3 | Nadia Petrova | 2023-03-16 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-032 | PK | Safety | SmPC Section 4.2 | Regulatory Authority guidance | 1 | Priya Sharma | 2023-01-21 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-033 | Special Population | Nonclinical | SmPC Section 4.4 | Expert panel consensus | 2 | Dmitri Volkov | 2023-06-14 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-034 | Special Population | Quality | SmPC Section 4.4 | Literature review 2024 | 6 | Marcus Webb | 2024-05-17 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-035 | Dosing | Nonclinical | SmPC Section 4.4 | Phase III RCT data | 3 | Lieselotte van der Berg | 2024-04-18 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-036 | Safety | Clinical | SmPC Section 4.2 | Clinical Study KCL-001 | 1 | Nadia Petrova | 2023-03-19 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-037 | PK | Quality | SmPC Section 4.1 | Expert panel consensus | 6 | Tomoko Ikeda | 2024-01-12 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-038 | Contraindication | Quality | SmPC Section 4.2 | Literature review 2024 | 8 | Lieselotte van der Berg | 2023-12-30 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-039 | Dosing | Quality | SmPC Section 4.4 | Clinical Study KCL-001 | 7 | Marcus Webb | 2024-05-18 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-040 | Special Population | Quality | SmPC Section 4.2 | Phase III RCT data | 3 | James O'Brien | 2022-11-09 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-041 | Efficacy | Nonclinical | SmPC Section 5.1 | Expert panel consensus | 3 | James O'Brien | 2022-12-07 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-042 | Efficacy | Quality | SmPC Section 4.8 | Regulatory Authority guidance | 1 | Sarah Chen | 2023-09-28 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-043 | Interaction | Safety | SmPC Section 5.2 | Expert panel consensus | 6 | Nadia Petrova | 2024-04-23 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-044 | Contraindication | Nonclinical | SmPC Section 5.1 | Regulatory Authority guidance | 2 | Carlos Mendez | 2023-01-20 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-045 | Interaction | Safety | SmPC Section 4.3 | Clinical Study KCL-001 | 4 | Priya Sharma | 2024-06-16 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-046 | PK | Nonclinical | SmPC Section 4.4 | Expert panel consensus | 5 | Marcus Webb | 2023-09-30 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-047 | Efficacy | Clinical | SmPC Section 4.5 | Literature review 2024 | 4 | Tomoko Ikeda | 2022-12-29 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-048 | Dosing | Safety | SmPC Section 4.2 | Expert panel consensus | 3 | Sarah Chen | 2023-03-09 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-049 | Contraindication | Nonclinical | SmPC Section 4.4 | Literature review 2024 | 2 | Tomoko Ikeda | 2023-12-06 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-050 | Efficacy | Quality | SmPC Section 4.5 | Expert panel consensus | 8 | Carlos Mendez | 2024-03-15 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-051 | Interaction | Safety | Core Data Sheet | Regulatory Authority guidance | 3 | Tomoko Ikeda | 2023-04-19 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-052 | Contraindication | Safety | SmPC Section 4.1 | Clinical Study KCL-001 | 8 | Aisha Okonkwo | 2023-09-23 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-053 | Safety | Safety | SmPC Section 4.8 | Literature review 2024 | 6 | Dmitri Volkov | 2022-11-07 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-054 | Safety | Safety | SmPC Section 4.8 | Clinical Study KCL-001 | 1 | Marcus Webb | 2023-05-04 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-055 | Dosing | Clinical | SmPC Section 4.1 | Expert panel consensus | 3 | Lieselotte van der Berg | 2023-11-27 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-056 | Special Population | Clinical | SmPC Section 4.5 | Expert panel consensus | 1 | Carlos Mendez | 2023-03-29 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-057 | PK | Clinical | SmPC Section 4.3 | Phase III RCT data | 3 | Sarah Chen | 2023-10-13 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-058 | Safety | Quality | SmPC Section 4.4 | Expert panel consensus | 1 | Dmitri Volkov | 2024-05-12 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-059 | Safety | Safety | SmPC Section 4.5 | Clinical Study KCL-001 | 1 | James O'Brien | 2023-11-17 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-060 | PK | Clinical | SmPC Section 4.4 | Literature review 2024 | 6 | Tomoko Ikeda | 2022-12-14 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-061 | Contraindication | Nonclinical | SmPC Section 4.4 | Expert panel consensus | 5 | Marcus Webb | 2024-02-24 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-062 | Contraindication | Safety | SmPC Section 4.3 | Regulatory Authority guidance | 6 | Aisha Okonkwo | 2023-09-26 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-063 | Interaction | Clinical | SmPC Section 5.2 | Literature review 2024 | 4 | Marcus Webb | 2024-03-28 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-064 | Safety | Clinical | SmPC Section 4.3 | Expert panel consensus | 1 | Carlos Mendez | 2023-09-24 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-065 | Interaction | Quality | SmPC Section 4.8 | Phase III RCT data | 3 | Carlos Mendez | 2023-08-21 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-066 | Contraindication | Nonclinical | SmPC Section 4.3 | Regulatory Authority guidance | 8 | Carlos Mendez | 2022-11-05 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-067 | Safety | Quality | SmPC Section 4.8 | Literature review 2024 | 8 | Marcus Webb | 2023-11-21 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-068 | Special Population | Clinical | SmPC Section 4.2 | Expert panel consensus | 2 | James O'Brien | 2023-07-15 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-069 | Dosing | Quality | SmPC Section 4.1 | Regulatory Authority guidance | 7 | Aisha Okonkwo | 2023-05-01 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-070 | Dosing | Clinical | SmPC Section 4.5 | Clinical Study KCL-001 | 7 | Tomoko Ikeda | 2023-03-07 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-071 | Special Population | Nonclinical | SmPC Section 5.2 | Literature review 2024 | 7 | Carlos Mendez | 2023-07-28 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-072 | Special Population | Safety | Core Data Sheet | Expert panel consensus | 7 | Dmitri Volkov | 2023-11-22 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-073 | PK | Quality | SmPC Section 5.2 | Regulatory Authority guidance | 1 | Marcus Webb | 2023-10-23 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-074 | Efficacy | Nonclinical | SmPC Section 4.3 | Clinical Study KCL-001 | 1 | James O'Brien | 2022-11-14 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… |
| STMT-075 | Interaction | Quality | SmPC Section 4.2 | Phase III RCT data | 5 | Aisha Okonkwo | 2023-02-14 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-076 | PK | Safety | SmPC Section 4.3 | Literature review 2024 | 6 | Lieselotte van der Berg | 2024-05-09 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-077 | Dosing | Safety | SmPC Section 4.2 | Regulatory Authority guidance | 1 | Priya Sharma | 2023-10-29 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-078 | Special Population | Clinical | SmPC Section 4.1 | Expert panel consensus | 3 | Tomoko Ikeda | 2024-02-02 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-079 | PK | Quality | SmPC Section 4.2 | Phase III RCT data | 8 | Nadia Petrova | 2023-10-16 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-080 | Dosing | Safety | SmPC Section 4.1 | Phase III RCT data | 5 | Tomoko Ikeda | 2023-09-21 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-081 | Efficacy | Safety | SmPC Section 4.2 | Expert panel consensus | 2 | Tomoko Ikeda | 2023-07-08 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-082 | Safety | Quality | SmPC Section 4.5 | Literature review 2024 | 4 | Lieselotte van der Berg | 2023-09-02 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-083 | Safety | Quality | SmPC Section 4.2 | Phase III RCT data | 1 | Sarah Chen | 2023-03-30 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-084 | Contraindication | Quality | Core Data Sheet | Literature review 2024 | 2 | Tomoko Ikeda | 2024-03-03 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-085 | Interaction | Quality | Core Data Sheet | Literature review 2024 | 2 | Tomoko Ikeda | 2024-02-20 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-086 | Safety | Nonclinical | SmPC Section 4.2 | Phase III RCT data | 7 | Aisha Okonkwo | 2023-06-28 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-087 | Efficacy | Quality | SmPC Section 4.4 | Regulatory Authority guidance | 8 | Tomoko Ikeda | 2023-06-22 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-088 | Special Population | Clinical | SmPC Section 4.2 | Expert panel consensus | 6 | Carlos Mendez | 2023-04-20 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-089 | PK | Safety | SmPC Section 5.1 | Phase III RCT data | 8 | Aisha Okonkwo | 2023-10-23 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-090 | Special Population | Clinical | SmPC Section 4.3 | Literature review 2024 | 3 | Carlos Mendez | 2023-04-02 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-091 | PK | Clinical | Core Data Sheet | Clinical Study KCL-001 | 3 | Nadia Petrova | 2023-04-14 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… |
| STMT-092 | PK | Nonclinical | SmPC Section 4.4 | Literature review 2024 | 4 | Marcus Webb | 2023-02-17 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… |
| STMT-093 | Efficacy | Clinical | SmPC Section 5.2 | Literature review 2024 | 8 | Sarah Chen | 2023-03-08 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-094 | Safety | Clinical | SmPC Section 4.4 | Literature review 2024 | 5 | Aisha Okonkwo | 2023-12-30 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-095 | Efficacy | Nonclinical | SmPC Section 4.5 | Regulatory Authority guidance | 8 | Priya Sharma | 2023-11-20 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-096 | Special Population | Safety | SmPC Section 5.2 | Literature review 2024 | 7 | Lieselotte van der Berg | 2024-02-02 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-097 | Dosing | Clinical | SmPC Section 4.4 | Expert panel consensus | 4 | Marcus Webb | 2023-05-30 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-098 | Contraindication | Quality | SmPC Section 4.5 | Expert panel consensus | 3 | James O'Brien | 2023-05-06 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-099 | Safety | Nonclinical | SmPC Section 4.8 | Expert panel consensus | 7 | Marcus Webb | 2023-10-26 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-100 | Dosing | Clinical | SmPC Section 5.2 | Clinical Study KCL-001 | 3 | Tomoko Ikeda | 2024-05-09 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-101 | Dosing | Quality | Core Data Sheet | Phase III RCT data | 2 | Priya Sharma | 2023-08-09 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-102 | Special Population | Clinical | SmPC Section 4.5 | Regulatory Authority guidance | 6 | Dmitri Volkov | 2023-09-07 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-103 | Safety | Nonclinical | SmPC Section 4.1 | Clinical Study KCL-001 | 4 | Nadia Petrova | 2023-10-09 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-104 | Dosing | Nonclinical | SmPC Section 5.1 | Clinical Study KCL-001 | 6 | Dmitri Volkov | 2024-05-25 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-105 | Contraindication | Nonclinical | Core Data Sheet | Literature review 2024 | 2 | Priya Sharma | 2023-01-08 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-106 | Safety | Nonclinical | SmPC Section 4.4 | Clinical Study KCL-001 | 6 | Carlos Mendez | 2023-02-26 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-107 | Contraindication | Quality | SmPC Section 4.5 | Regulatory Authority guidance | 4 | Sarah Chen | 2024-01-10 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-108 | Efficacy | Nonclinical | SmPC Section 4.1 | Phase III RCT data | 5 | Dmitri Volkov | 2023-07-25 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-109 | PK | Nonclinical | SmPC Section 4.2 | Regulatory Authority guidance | 3 | Priya Sharma | 2023-01-03 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-110 | Contraindication | Clinical | SmPC Section 4.4 | Regulatory Authority guidance | 5 | Priya Sharma | 2023-02-14 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-111 | Interaction | Clinical | SmPC Section 4.1 | Phase III RCT data | 3 | Sarah Chen | 2023-01-02 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-112 | Contraindication | Nonclinical | SmPC Section 5.2 | Regulatory Authority guidance | 7 | James O'Brien | 2023-06-07 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-113 | Contraindication | Safety | SmPC Section 4.5 | Phase III RCT data | 1 | Lieselotte van der Berg | 2023-07-29 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-114 | Interaction | Quality | SmPC Section 5.2 | Expert panel consensus | 5 | Carlos Mendez | 2023-08-25 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-115 | Contraindication | Clinical | SmPC Section 4.2 | Literature review 2024 | 3 | Priya Sharma | 2024-01-20 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-116 | Safety | Safety | SmPC Section 4.5 | Regulatory Authority guidance | 1 | Tomoko Ikeda | 2023-07-26 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-117 | Dosing | Clinical | SmPC Section 5.1 | Regulatory Authority guidance | 2 | Nadia Petrova | 2023-12-17 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-118 | Efficacy | Quality | SmPC Section 4.8 | Regulatory Authority guidance | 2 | James O'Brien | 2022-11-22 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-119 | Contraindication | Nonclinical | SmPC Section 5.1 | Literature review 2024 | 4 | Dmitri Volkov | 2024-05-18 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-120 | PK | Clinical | SmPC Section 4.1 | Expert panel consensus | 6 | Aisha Okonkwo | 2023-06-19 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-121 | Safety | Safety | SmPC Section 4.1 | Phase III RCT data | 8 | Tomoko Ikeda | 2024-02-19 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-122 | Interaction | Clinical | SmPC Section 4.5 | Expert panel consensus | 5 | Sarah Chen | 2024-06-14 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-123 | PK | Clinical | SmPC Section 4.2 | Expert panel consensus | 6 | Tomoko Ikeda | 2022-11-03 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-124 | Dosing | Safety | SmPC Section 4.4 | Literature review 2024 | 4 | Priya Sharma | 2024-03-10 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-125 | Contraindication | Safety | SmPC Section 4.8 | Phase III RCT data | 7 | Priya Sharma | 2023-09-27 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-126 | Dosing | Quality | Core Data Sheet | Expert panel consensus | 1 | Lieselotte van der Berg | 2023-04-30 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-127 | Contraindication | Clinical | SmPC Section 4.8 | Expert panel consensus | 1 | Priya Sharma | 2023-08-28 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… |
| STMT-128 | Dosing | Clinical | SmPC Section 4.1 | Regulatory Authority guidance | 6 | Dmitri Volkov | 2024-01-27 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-129 | Efficacy | Quality | SmPC Section 4.2 | Phase III RCT data | 3 | Priya Sharma | 2024-05-06 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-130 | Safety | Nonclinical | SmPC Section 4.8 | Clinical Study KCL-001 | 1 | Tomoko Ikeda | 2024-05-21 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-131 | Safety | Nonclinical | SmPC Section 4.2 | Clinical Study KCL-001 | 1 | Tomoko Ikeda | 2024-02-01 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-132 | Contraindication | Clinical | SmPC Section 4.4 | Literature review 2024 | 4 | Aisha Okonkwo | 2023-10-01 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-133 | Contraindication | Safety | SmPC Section 5.2 | Regulatory Authority guidance | 1 | Aisha Okonkwo | 2022-10-30 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-134 | Safety | Nonclinical | SmPC Section 4.8 | Clinical Study KCL-001 | 7 | Aisha Okonkwo | 2024-05-13 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-135 | Safety | Safety | SmPC Section 5.1 | Phase III RCT data | 8 | Dmitri Volkov | 2024-05-20 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-136 | Contraindication | Safety | SmPC Section 4.3 | Clinical Study KCL-001 | 3 | Nadia Petrova | 2023-05-14 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-137 | Contraindication | Quality | SmPC Section 4.2 | Phase III RCT data | 4 | Carlos Mendez | 2023-09-18 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-138 | PK | Clinical | SmPC Section 4.5 | Expert panel consensus | 7 | Tomoko Ikeda | 2023-10-17 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-139 | Dosing | Quality | SmPC Section 4.1 | Regulatory Authority guidance | 2 | Lieselotte van der Berg | 2023-05-10 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-140 | Special Population | Clinical | SmPC Section 5.1 | Expert panel consensus | 6 | James O'Brien | 2023-08-02 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-141 | PK | Quality | SmPC Section 4.4 | Literature review 2024 | 5 | Carlos Mendez | 2024-02-19 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-142 | Contraindication | Clinical | Core Data Sheet | Phase III RCT data | 8 | James O'Brien | 2024-03-04 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-143 | PK | Safety | Core Data Sheet | Phase III RCT data | 1 | James O'Brien | 2023-04-22 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-144 | Contraindication | Clinical | Core Data Sheet | Regulatory Authority guidance | 8 | Aisha Okonkwo | 2024-04-03 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-145 | Contraindication | Nonclinical | SmPC Section 5.1 | Literature review 2024 | 1 | Tomoko Ikeda | 2023-08-08 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-146 | Interaction | Safety | SmPC Section 5.2 | Phase III RCT data | 4 | Carlos Mendez | 2023-10-02 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-147 | Special Population | Nonclinical | SmPC Section 5.2 | Expert panel consensus | 4 | Dmitri Volkov | 2023-05-15 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-148 | Safety | Nonclinical | SmPC Section 4.3 | Phase III RCT data | 8 | Carlos Mendez | 2024-01-18 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-149 | Safety | Quality | SmPC Section 4.5 | Phase III RCT data | 8 | Marcus Webb | 2023-07-24 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-150 | Special Population | Quality | SmPC Section 4.4 | Clinical Study KCL-001 | 1 | Dmitri Volkov | 2024-02-09 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-151 | Safety | Quality | Core Data Sheet | Clinical Study KCL-001 | 5 | Nadia Petrova | 2024-04-23 | This product has been designated as an orphan medicine in the European Union.… |
| STMT-152 | Safety | Clinical | SmPC Section 4.3 | Phase III RCT data | 6 | Nadia Petrova | 2023-07-18 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-153 | Efficacy | Clinical | SmPC Section 4.1 | Clinical Study KCL-001 | 8 | Dmitri Volkov | 2024-06-16 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-154 | Dosing | Quality | SmPC Section 5.1 | Phase III RCT data | 2 | Carlos Mendez | 2022-12-17 | Treatment should be initiated under the supervision of a physician experienced i… |
| STMT-155 | Contraindication | Clinical | SmPC Section 4.3 | Clinical Study KCL-001 | 3 | Nadia Petrova | 2023-09-18 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-156 | Interaction | Clinical | SmPC Section 5.1 | Clinical Study KCL-001 | 1 | Lieselotte van der Berg | 2024-03-02 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-157 | PK | Safety | Core Data Sheet | Clinical Study KCL-001 | 4 | Dmitri Volkov | 2023-07-07 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-158 | PK | Safety | Core Data Sheet | Literature review 2024 | 1 | James O'Brien | 2023-11-13 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-159 | Special Population | Quality | SmPC Section 4.8 | Regulatory Authority guidance | 4 | Marcus Webb | 2024-02-15 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-160 | PK | Safety | SmPC Section 5.2 | Clinical Study KCL-001 | 8 | Dmitri Volkov | 2024-01-02 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-161 | PK | Quality | SmPC Section 4.2 | Regulatory Authority guidance | 6 | Nadia Petrova | 2023-07-17 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-162 | Contraindication | Safety | SmPC Section 4.3 | Literature review 2024 | 8 | Tomoko Ikeda | 2023-09-21 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-163 | Special Population | Safety | SmPC Section 4.2 | Phase III RCT data | 5 | Nadia Petrova | 2022-11-03 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-164 | Safety | Nonclinical | SmPC Section 4.3 | Phase III RCT data | 3 | Marcus Webb | 2023-12-10 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-165 | Dosing | Clinical | SmPC Section 5.2 | Clinical Study KCL-001 | 6 | James O'Brien | 2022-11-18 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-166 | Efficacy | Nonclinical | SmPC Section 4.3 | Expert panel consensus | 2 | Sarah Chen | 2024-02-05 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-167 | Special Population | Safety | SmPC Section 4.4 | Literature review 2024 | 1 | Tomoko Ikeda | 2023-01-27 | This medicinal product is contraindicated in patients with known hypersensitivit… |
| STMT-168 | Dosing | Quality | SmPC Section 5.1 | Clinical Study KCL-001 | 4 | Sarah Chen | 2024-01-13 | Fertility studies in animals have not shown any adverse effects on fertility.… |
| STMT-169 | Contraindication | Safety | SmPC Section 4.3 | Regulatory Authority guidance | 5 | Tomoko Ikeda | 2023-03-08 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-170 | Safety | Nonclinical | SmPC Section 4.5 | Phase III RCT data | 3 | Priya Sharma | 2022-11-08 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-171 | Dosing | Nonclinical | SmPC Section 4.1 | Regulatory Authority guidance | 8 | Marcus Webb | 2023-02-23 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-172 | Efficacy | Clinical | SmPC Section 4.2 | Expert panel consensus | 7 | Aisha Okonkwo | 2023-08-15 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-173 | Contraindication | Clinical | SmPC Section 4.2 | Phase III RCT data | 7 | Tomoko Ikeda | 2024-02-18 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-174 | Interaction | Safety | SmPC Section 4.1 | Literature review 2024 | 6 | Dmitri Volkov | 2024-04-04 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-175 | Safety | Clinical | SmPC Section 4.5 | Regulatory Authority guidance | 6 | Aisha Okonkwo | 2024-03-25 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-176 | Dosing | Clinical | SmPC Section 4.2 | Phase III RCT data | 1 | Aisha Okonkwo | 2022-12-17 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-177 | Dosing | Quality | SmPC Section 5.1 | Literature review 2024 | 4 | Marcus Webb | 2023-06-17 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-178 | Interaction | Clinical | SmPC Section 4.8 | Regulatory Authority guidance | 2 | James O'Brien | 2023-01-16 | The medicinal product should not be used during pregnancy unless clearly necessa… |
| STMT-179 | Efficacy | Quality | SmPC Section 4.2 | Literature review 2024 | 4 | James O'Brien | 2022-12-28 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-180 | Special Population | Clinical | Core Data Sheet | Expert panel consensus | 1 | Sarah Chen | 2024-04-17 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-181 | PK | Quality | SmPC Section 4.3 | Literature review 2024 | 1 | James O'Brien | 2024-02-25 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-182 | Safety | Clinical | SmPC Section 4.1 | Regulatory Authority guidance | 6 | Marcus Webb | 2023-09-28 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-183 | Contraindication | Safety | SmPC Section 4.8 | Expert panel consensus | 1 | Lieselotte van der Berg | 2023-06-13 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-184 | Dosing | Safety | Core Data Sheet | Phase III RCT data | 2 | Dmitri Volkov | 2023-05-20 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-185 | Interaction | Safety | SmPC Section 5.1 | Literature review 2024 | 5 | Nadia Petrova | 2023-11-01 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-186 | Special Population | Safety | SmPC Section 4.1 | Phase III RCT data | 7 | James O'Brien | 2023-01-02 | Renal impairment does not significantly alter the pharmacokinetics of this compo… |
| STMT-187 | PK | Quality | SmPC Section 4.3 | Clinical Study KCL-001 | 4 | Tomoko Ikeda | 2022-12-10 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-188 | PK | Quality | SmPC Section 5.1 | Expert panel consensus | 8 | Aisha Okonkwo | 2023-12-23 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-189 | Interaction | Safety | SmPC Section 4.8 | Expert panel consensus | 5 | Priya Sharma | 2023-11-21 | No dose adjustment is required in patients with mild to moderate hepatic impairm… |
| STMT-190 | Safety | Safety | SmPC Section 4.1 | Literature review 2024 | 3 | Lieselotte van der Berg | 2024-04-22 | Patients should be advised not to drive or operate machinery if they experience … |
| STMT-191 | Interaction | Quality | SmPC Section 4.3 | Regulatory Authority guidance | 7 | Tomoko Ikeda | 2023-03-01 | The mean terminal half-life is approximately 18 hours following oral administrat… |
| STMT-192 | Dosing | Safety | SmPC Section 5.2 | Clinical Study KCL-001 | 6 | Priya Sharma | 2024-02-09 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… |
| STMT-193 | Special Population | Quality | SmPC Section 5.2 | Regulatory Authority guidance | 4 | Aisha Okonkwo | 2024-05-26 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-194 | Contraindication | Nonclinical | SmPC Section 4.8 | Literature review 2024 | 6 | Nadia Petrova | 2023-02-07 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… |
| STMT-195 | Efficacy | Quality | SmPC Section 4.1 | Literature review 2024 | 8 | James O'Brien | 2023-01-04 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-196 | Safety | Quality | SmPC Section 4.2 | Expert panel consensus | 4 | Lieselotte van der Berg | 2024-03-22 | A paediatric investigation plan (PIP) has been agreed with the EMA.… |
| STMT-197 | Contraindication | Nonclinical | SmPC Section 5.1 | Phase III RCT data | 1 | Lieselotte van der Berg | 2023-06-29 | The recommended dose is 10 mg once daily administered orally.… |
| STMT-198 | Efficacy | Quality | SmPC Section 5.2 | Clinical Study KCL-001 | 3 | Sarah Chen | 2023-03-25 | Long-term studies in animals have shown no evidence of carcinogenic potential.… |
| STMT-199 | Interaction | Safety | SmPC Section 4.3 | Phase III RCT data | 8 | Priya Sharma | 2023-11-12 | The pharmacokinetic profile is linear over the therapeutic dose range of 5–200 m… |
| STMT-200 | Dosing | Quality | Core Data Sheet | Literature review 2024 | 3 | Aisha Okonkwo | 2023-04-23 | The mean terminal half-life is approximately 18 hours following oral administrat… |
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