MEDOVIR Tablet Ref.[28214] Active ingredients: Aciclovir

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medovir, 200 mg, tablets.
Medovir, 400 mg, tablets.
Medovir, 800 mg, tablets.

Pharmaceutical Form

Tablet.

Medovir 200 mg: white, flat, round scored tablets.

Medovir 400 mg: marble pink, flat, round, scored on one side tablets.

Medovir 800 mg: marble light blue capsule-shaped, embossed “MC”, scored on one side tablets.

The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

Each Medovir 200 mg, tablet contains 200 mg of aciclovir.

Each Medovir 400 mg tablet contains 400 mg of aciclovir.

Each Medovir 800 mg tablet contains 800 mg of aciclovir.

Excipient with known effect: lactose monohydrate.

Each Medovir 200 mg, tablet contains 100 mg lactose.

Each Medovir 400 mg tablet contains 90.5 mg lactose.

Each Medovir 800 mg tablet contains 91 mg lactose.

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

Medovir 200 mg tablets: lactose monohydrate, pregelatinised starch, sodium croscaramellose, magnesium stearate.

Medovir 400 mg tablets: lactose monohydrate, cellulose microcrystalline, sodium croscaramellose, magnesium stearate, erythrosine aluminium lake (E127).

Medovir 800 mg tablets: lactose monohydrate, cellulose microcrystalline, sodium croscaramellose, magnesium stearate and blue lake (E132).

Pack sizes and marketing

Combination of polyvinylchloride and aluminium blisters in a carton with the patient information leaflet. Cartons of 10, 30, 35, 40 100, 500 and 1000 tablets are available.

Medovir 400 mg tablets have additional carton pack with 70 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

Aciclovir 200 mg: 12781
Aciclovir 400 mg: 14927
Aciclovir 800 mg: 14928

Date of first authorisation:

Aciclovir 200 mg: 06/06/1990
Aciclovir 400 mg: 13/02/1994
Aciclovir 800 mg: 13/02/1994

Date of latest renewal:

Aciclovir 200 mg: 26/09/2012
Aciclovir 400 mg: 05/07/2013
Aciclovir 800 mg: 26/09/2012

Drugs

Drug Countries
MEDOVIR Cyprus, Estonia, Hong Kong, Malta, Singapore

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