GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Efavirenz Tablets USP 200mg
B) Efavirenz Tablets USP 600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Efavirenz Tablets USP 200mg
Each film-coated tablet contains:
Efavirenz USP……………….200mg
Excipients……………………..q.s.
Colour: Titanium Dioxide USP

B) Efavirenz Tablets USP 600mg
Each film-coated tablet contains:
Efavirenz USP……………….600mg
Excipients……………………..q.s.
Colour: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

Efavirenz is used along with other medications to treat human immunodeficiency virus (HIV) infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT SPIT, CHEW OR CRUSH.
FIND OUT ABOUT MEDICINE THAT SHOULD NOT BE TAKEN WITH EFAVIRENZ.
WARNING: It is dangerous to take this medication except in accordance with medical advice.

STORAGE & DOSAGE:

Storage: Store at 25°C (77°F) excusion permitted to 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Efavirenz Tablets USP 600mg Technical Specification:

Product Name:Efavirenz Tablets USP
Brand Name:Generic
Strength:200mg, 600mg
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiretrovirals, HIV, AIDS
Indication: Efavirenz is used along with other medications to treat human immunodeficiency virus (HIV) infection.
Storage:Store at 25°C (77°F) excusion permitted to 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Efavirenz Tablets USP 200mg
  • Efavirenz Tablets USP 600mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Efavirenz Tablets USP 200mg
    Each film-coated tablet contains:
    Efavirenz USP……………….200mg
    Excipients……………………..q.s.
    Colour: Titanium Dioxide USP
  • Efavirenz Tablets USP 600mg
    Each film-coated tablet contains:
    Efavirenz USP……………….600mg
    Excipients……………………..q.s.
    Colour: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

Efavirenz is used along with other medications to treat human immunodeficiency virus (HIV) infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT SPIT, CHEW OR CRUSH.
Find out about medicine that should not be taken with Efavirenz.
Warning: It is dangerous to take this medication except in accordance with medical advice

STORAGE & DOSAGE:

Storage: Store at 25°C (77°F) excusion permitted to 15°C to 30°C (59°F to 86°F)[see USP Controlled Room Temperature].
Dispense in tight container.
Dosage: As directed by the Physician
Attach dispensing label as per end country.