gadopiclenol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| diagnostic agents, gadolinium derivatives | 5681 | 933983-75-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Gadopiclenol is a paramagnetic molecule (macrocyclic non-ionic complex of gadolinium) that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 21, 2022 | FDA | GUERBET S.A. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V08CA12 | VARIOUS CONTRAST MEDIA MAGNETIC RESONANCE IMAGING CONTRAST MEDIA Paramagnetic contrast media |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Detect and visualize lesions with abnormal vascularity with MRI | indication | 767426001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1.4553GM/3ML (485.1MG/ML) | ELUCIREM | GUERBET | N216986 | Sept. 21, 2022 | RX | SOLUTION | INTRAVENOUS | Sept. 21, 2027 | NEW CHEMICAL ENTITY |
| 14.553GM/30ML (485.1MG/ML) | ELUCIREM | GUERBET | N216986 | Sept. 21, 2022 | RX | SOLUTION | INTRAVENOUS | Sept. 21, 2027 | NEW CHEMICAL ENTITY |
| 24.255GM/50ML (485.1MG/ML) | ELUCIREM | GUERBET | N216986 | Sept. 21, 2022 | RX | SOLUTION | INTRAVENOUS | Sept. 21, 2027 | NEW CHEMICAL ENTITY |
| 3.63825GM/7.5ML (485.1MG/ML) | ELUCIREM | GUERBET | N216986 | Sept. 21, 2022 | RX | SOLUTION | INTRAVENOUS | Sept. 21, 2027 | NEW CHEMICAL ENTITY |
| 4.851GM/10ML (485.1MG/ML) | ELUCIREM | GUERBET | N216986 | Sept. 21, 2022 | RX | SOLUTION | INTRAVENOUS | Sept. 21, 2027 | NEW CHEMICAL ENTITY |
| 48.51GM/100ML (485.1MG/ML) | ELUCIREM | GUERBET | N216986 | Sept. 21, 2022 | RX | SOLUTION | INTRAVENOUS | Sept. 21, 2027 | NEW CHEMICAL ENTITY |
| 7.2765GM/15ML (485.1MG/ML) | ELUCIREM | GUERBET | N216986 | Sept. 21, 2022 | RX | SOLUTION | INTRAVENOUS | Sept. 21, 2027 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| CHEMBL4297634 | ChEMBL_ID |
| C000656634 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB17084 | DRUGBANK_ID |
| 019209 | NDDF |
| 4041872 | VANDF |
| C5392287 | UMLSCUI |
| 10744 | INN_ID |
| D12435 | KEGG_DRUG |
| 16223405 | PUBCHEM_CID |
| 2618720 | RXNORM |
| 368327 | MMSL |
| 41266 | MMSL |
| d10016 | MMSL |
| S276568KOY | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Vueway | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-7015 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 26 sections |
| Vueway | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-7020 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 26 sections |
| Vueway | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-7025 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 26 sections |
| Vueway | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-7030 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 26 sections |
| Vueway | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0270-7035 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 26 sections |
| ELUCIREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-4230 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 28 sections |
| ELUCIREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-4231 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 28 sections |
| ELUCIREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-4232 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 28 sections |
| ELUCIREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-4233 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 28 sections |
| ELUCIREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-4240 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 28 sections |
| ELUCIREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-4241 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 28 sections |
| ELUCIREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-4242 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 28 sections |
| ELUCIREM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67684-4250 | INJECTION | 485.10 mg | INTRAVENOUS | NDA | 28 sections |