REBETOL Hard capsule Ref.[8114] Active ingredients: Ribavirin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

Rebetol 200 mg hard capsules.

Pharmaceutical Form

Hard capsule (capsule).

White, opaque and imprinted with blue ink.

Qualitative and quantitative composition

Each hard capsule contains 200 mg of ribavirin.

Excipient with known effect: Each hard capsule contains 40 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ribavirin

Ribavirin is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses. The mechanism by which ribavirin in combination with other medicinal products exerts its effects against HCV is unknown.

List of Excipients

Capsule contents:

Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate

Capsule shell:

Gelatine
Titanium dioxide

Capsule imprint:

Shellac
Propylene glycol
Ammonium hydroxide
Colouring agent (E132)

Pack sizes and marketing

Rebetol capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).

Packs of 84, 112, 140 and 168 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/99/107/001 84 hard capsules
EU/1/99/107/005 112 hard capsules
EU/1/99/107/002 140 hard capsules
EU/1/99/107/003 168 hard capsules

Date of first authorisation: 07 May 1999
Date of latest renewal: 23 April 2009

Drugs

Drug Countries
REBETOL Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States

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