REMEDOL Suppository Ref.[50371] Active ingredients: Paracetamol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Remedol 125 mg suppositories.

Remedol 250 mg suppositories.

Remedol 500 mg suppositories.

Pharmaceutical Form

Suppository.

Off-white, torpedo-shaped suppositories.

Qualitative and quantitative composition

Remedol 125 mg suppositories: Each suppository contains 125 mg paracetamol.

Remedol 250 mg suppositories: Each suppository contains 250 mg paracetamol.

Remedol 500 mg suppositories: Each suppository contains 500 mg paracetamol.

For full list of excipients see section 6.1.

Active Ingredient Description
Paracetamol

Paracetamol is a medication used to treat pain and fever. It does appear to selectively inhibit COX activities in the brain, which may contribute to its ability to treat fever and pain.

List of Excipients

Hard fat

Pack sizes and marketing

PVC strips. Pack size of 10 suppositories.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Remedol 125 mg suppositories: 19737
Remedol 250 mg suppositories: 14626
Remedol 500 mg suppositories: 14627

Remedol 125 mg suppositories:

Date of first authorisation: 08 November 2005
Date of latest renewal: 20 April 2011

Remedol 250 mg suppositories:

Date of first authorisation: 10 February 1994
Date of latest renewal: 30 September 2011

Remedol 500 mg suppositories:

Date of first authorisation: 10 February 1994
Date of latest renewal: 30 September 2011

Drugs

Drug Countries
REMEDOL Cyprus, Malta, Singapore

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