Idebenone Tablets 90mg Technical Specification:
| Product Name: | Idebenone Tablets 90mg |
| Brand Name: | Generic |
| Strength: | (45mg), (90mg) |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s ,100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-oxidants |
| Indication: | Idebenone is an analogue of ubiquinone used for the treatment of visual impairment in adolescent and adult patients with Friedreich’s ataxia and Leber’s Hereditary Optic Neuropathy (LHON). |
| Storage: | Protect from Light, Store in a cool and dry place. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Idebenone Tablets 45mg
- Idebenone Tablets 90mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Idebenone Tablets 45mg
Each Film-coated Tablets contains:
Idebenone………………45mg
Excipients………………Q.s.
Colors: Yellow Oxide of Iron
- Idebenone Tablets 90mg
Each Film-coated Tablets contains:
Idebenone………………90mg
Excipients………………Q.s.
Colors: Sunset Yellow
THERAPEUTIC INDICATIONS:
Idebenone is an analogue of ubiquinone used for the treatment of visual impairment in adolescent and adult patients with Friedreich’s ataxia and Leber’s Hereditary Optic Neuropathy (LHON).
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protect from Light, Store in a cool and dry place.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Idebenone Tablets 45mg
B. Idebenone Tablets 90mg
B. Idebenone Tablets 90mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Idebenone Tablets 45mg
Each Film coated Tablets contains:
Idebenone………………45mg
Excipients………………Q.s.
Colurs: Yellow Oxide of Iron
b) Idebenone Tablets 90mg
Each Film coated Tablets contains:
Idebenone………………90mg
Excipients………………Q.s.
Colurs: Sunset Yellow
Each Film coated Tablets contains:
Idebenone………………45mg
Excipients………………Q.s.
Colurs: Yellow Oxide of Iron
b) Idebenone Tablets 90mg
Each Film coated Tablets contains:
Idebenone………………90mg
Excipients………………Q.s.
Colurs: Sunset Yellow
THERAPEUTIC INDICATIONS:
Idebenone is an analogue of ubiquinone used for the treatment of visual impairment in adolescent and adult patients with Friedreich's ataxia and Leber’s Hereditary Optic Neuropathy (LHON).
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Protect from Light, Store in a cool and dry place.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
