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HSA Approval

COMPLERA FILM-COATED TABLET 200MG/25MG/300MG

SIN14965P

COMPLERA FILM-COATED TABLET 200MG/25MG/300MG

COMPLERA FILM-COATED TABLET 200MG/25MG/300MG

February 29, 2016

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantJOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

TABLET, FILM COATED

ORAL

Medical Information

J05AR08

emtricitabine, tenofovir disoproxil and rilpivirine

Manufacturer Information

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.

Patheon, Inc.

Gilead Sciences Ireland UC

Active Ingredients

Tenofovir disoproxil 245mg eqv Tenofovir disoproxil fumarate

300 mg

Tenofovir disoproxil

Rilpivirine hydrochloride 27.5mg eqv Rilpivirine

25 mg

Rilpivirine

Emtricitabine

200 mg

Emtricitabine

Documents

Package Inserts

Complera_PI.pdf

Approved: March 8, 2023

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