Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Rebetol 200 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). White, opaque and imprinted with blue ink. |
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 Capsule shell: Gelatine Capsule imprint: Shellac |
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.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
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
| 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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