PIVMECILLINAM Film-coated tablet Ref.[8310] Active ingredients: Pivmecillinam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Product name and form

Pivmecillinam hydrochloride 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to off-white, round shaped, biconvex, film coated tablets debossed with ‘F’ on one side and ‘48’ on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg of pivmecillinam hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Pivmecillinam

Pivmecillinam is an orally active antibiotic. It is the pivaloyloxymethylester of the amidinopenicillanic acid, mecillinam. Mecillinam is a betalactam with a narrow-spectrum of activity. It is mainly active against Gram-negative bacteria and works by interfering with the biosynthesis of the bacterial cell wall.

List of Excipients

Tablet core:

Cellulose microcrystalline
Magnesium stearate

Film coating:

Hypromellose
Triacetin

Pack sizes and marketing

Pivmecillinam hydrochloride film-coated tablets are available in PVC/OPA/aluminum/PVC/Paper/PET/aluminum foil blister pack.

Pack sizes: 2, 10, 14 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0442

07.10.2015

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