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REYATAZ Hard capsules (2019)

Active ingredients: Atazanavir

Product Name and Form

REYATAZ 100 mg hard capsules.
REYATAZ 150 mg hard capsules.
REYATAZ 200 mg hard capsules.
REYATAZ 300 mg hard capsules.

Pharmaceutical form

Hard capsule.

REYATAZ 100 mg hard capsules: Opaque blue and white capsule printed with white and blue inks, with “BMS 100 mg” on one half and with “3623” on the other half.

REYATAZ 150 mg hard capsules: Opaque blue and powder blue capsule printed with white and blue inks, with “BMS 150 mg” on one half and with “3624” on the other half.

REYATAZ 200 mg hard capsules: Opaque blue capsule printed with white ink, with “BMS 200 mg” on one half and with “3631” on the other half.

REYATAZ 300 mg hard capsules: Opaque red and blue capsule printed with white ink, with “BMS 300 mg” on one half and with “3622” on the other half.

Qualitative and Quantitative Composition

REYATAZ 100 mg hard capsules: Each capsule contains 100 mg of atazanavir (as sulphate).

Excipient with known effect: 54.79 mg of lactose per capsule.

REYATAZ 150 mg hard capsules: Each capsule contains 150 mg of atazanavir (as sulphate).

Excipient with known effect: 82.18 mg of lactose per capsule.

REYATAZ 200 mg hard capsules: Each capsule contains 200 mg of atazanavir (as sulphate).

Excipient with known effect: 109.57 mg of lactose per capsule.

REYATAZ 300 mg hard capsules: Each capsule contains 300 mg of atazanavir (as sulphate).

Excipient with known effect: 164.36 mg of lactose per capsule.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Atazanavir

Atazanavir is an azapeptide HIV-1 protease inhibitor (PI). The compound selectively inhibits the virus-specific processing of viral Gag-Pol proteins in HIV-1 infected cells, thus preventing formation of mature virions and infection of other cells.

List of excipients

REYATAZ 100 mg hard capsules

Capsule contents: crospovidone, lactose monohydrate and magnesium stearate

Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171)

Blue ink containing: shellac, propylene glycol, ammonium hydroxide and indigocarmin (E132)

White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone

REYATAZ 150 mg hard capsules

Capsule contents: crospovidone, lactose monohydrate and magnesium stearate

Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171)

Blue ink containing: shellac, propylene glycol, ammonium hydroxide and indigocarmin (E132)

White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone

REYATAZ 200 mg hard capsules

Capsule contents: crospovidone, lactose monohydrate and magnesium stearate

Capsule shells: gelatine, indigocarmin (E132) and titanium dioxide (E171)

White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone

REYATAZ 300 mg hard capsules

Capsule contents: crospovidone, lactose monohydrate and magnesium stearate

Capsule shells: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) and titanium dioxide (E171)

White ink containing: shellac, titanium dioxide (E171), ammonium hydroxide, propylene glycol and simethicone

Pack sizes and Marketing

REYATAZ 100 mg hard capsules: Each carton contains one high-density polyethylene (HDPE) bottle closed with child-resistant polypropylene closure. Each bottle contains 60 hard capsules.

Each carton contains 60 × 1 capsules; 10 blister cards of 6 × 1 capsules each in Alu/Alu perforated unit dose blisters.

REYATAZ 150 mg hard capsules: Each carton contains one high-density polyethylene (HDPE) bottle closed with child-resistant polypropylene closure. Each bottle contains 60 hard capsules.

Each carton contains 60 × 1 capsules; 10 blister cards of 6 × 1 capsules each in Alu/Alu perforated unit dose blisters.

REYATAZ 200 mg hard capsules: Each carton contains one high-density polyethylene (HDPE) bottle or three high-density polyethylene (HDPE) bottles closed with child-resistant polypropylene closure. Each bottle contains 60 hard capsules.

Each carton contains 60 × 1 capsules; 10 blister cards of 6 × 1 capsules each in Alu/Alu perforated unit dose blisters.

REYATAZ 300 mg hard capsules: Each carton contains one high-density polyethylene (HDPE) bottle or three high-density polyethylene (HDPE) bottles closed with child-resistant polypropylene closure. Each bottle contains 30 hard capsules.

Each carton contains 30 × 1 capsules; 5 blister cards of 6 × 1 capsules each in Alu/Alu perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

BRISTOL-MYERS SQUIBB PHARMA EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

Date of first authorisation: 02 March 2004

Date of latest renewal: 02 March 2009

Marketing authorization number:

EU/1/03/267/001-006; 008-011