RIFADIN Capsule Ref.[7697] Active ingredients: Rifampicin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Rifadin 150 mg Capsules.

Pharmaceutical Form

Capsule, hard.

The gelatin capsule is opaque, composed of a scarlet body and a light blue cap, marked R-150.

Qualitative and quantitative composition

Rifampicin Ph Eur 150 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rifampicin

Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and also has bactericidial activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

List of Excipients

Corn starch
Magnesium stearate

Capsule Shell:

Gelatin
Erytrosine
Indigotine
Titanium dioxide

Pack sizes and marketing

Amber glass bottles of 100 capsules.

Blister packs of 100 capsules in cardboard cartons. Blister material is aluminium foil/PVDC (Aluminium 0.025 mm; PVDC 20 gsm) and transparent PVC/PVDC foil (PVC 0.25 mm; PVDC 60 gsm).

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/5915R

Date of First Authorisation: 15 June 1982
Date of latest renewal: 09 April 2005

Drugs

Drug Countries
RIFADIN Australia, Estonia, Hong Kong, Ireland, Japan, Malta, Mexico, Netherlands, New Zealand, United Kingdom, United States, South Africa

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