SYNTOVIR Tablet Ref.[28265] Active ingredients: Aciclovir

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus

Product name and form

Syntovir 200 mg Tablets.

Syntovir 400 mg Tablets.

Syntovir 800 mg Tablets.

Pharmaceutical Form

Syntovir 200 mg: white, flat, round, scored on one side tablet.

Syntovir 400 mg: light yellow, round, scored on one side tablet.

Syntovir 800 mg: light blue, capsule-shaped, scored tablets.

Qualitative and quantitative composition

Syntovir 200 mg Tablets: Each tablet contains 200 mg Aciclovir.

Syntovir 400 mg Tablets: Each tablet contains 400 mg Aciclovir.

Syntovir 800 mg Tablets: Each tablet contains 800 mg Aciclovir.

Excipients with known effect: lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Aciclovir

Acyclovir is an antiviral agent with activity against herpes simplex virus and varicella-zoster virus. Acyclovir inhibits the DNA polymerase of the virus, preventing further proliferation.

List of Excipients

Aciclovir 200 mg: lactose monohydrate, pregelatinised maize starch, croscarmellose sodium , magnesium stearate.

Aciclovir 400 mg: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, quinoline yellow (E104).

Aciclovir 800 mg: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, magnesium stearate and blue lake no 2 (E132).

Pack sizes and marketing

Combination of polyvinylchloride and aluminium blisters in a carton with the patient information leaflet. Cartons of 10 and 30 tablets are available. Syntovir 800mg tablets are also available in cartons of 35, 500 and 1000 tablets.

Marketing authorization holder

Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Syntovir 200 mg: 18353
Syntovir 400 mg: 18352
Syntovir 800 mg: 18641

Syntovir 200 mg: 01/09/1999 / 03/12/2010
Syntovir 400 mg: 01/09/1999 / 30/11/2010
Syntovir 800 mg: 14/02/2000 / 19/04/2013

Drugs

Drug Countries
SYNTOVIR Cyprus, Hong Kong

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