CABASER Tablet Ref.[27760] Active ingredients: Cabergoline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ

Product name and form

Cabaser 1 mg Tablets.

Pharmaceutical Form

Tablet.

White, oval, 3.8 × 7.4 mm and both sides concave with one side scored and engraved ‘7’ on the left and ‘01’ on the right.

Qualitative and quantitative composition

1mg of cabergoline.

Excipient(s) with known effect:

Each tablet contains 75.4 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cabergoline

Cabergoline is a dopaminergic ergoline derivative endowed with a potent and long-lasting PRL-lowering activity.

List of Excipients

Lactose
Leucine

Pack sizes and marketing

Class I amber glass bottles, stoppered with an aluminium tamper-evident screw cap equipped with a low density polyethylene/thermoplastic elastomer (LDPE/TPE) plastic undercap acting as a container holding silica gel, closed by a plastic cap with a porous paper at the lower extremity.

Or

White high-density polyethylene (HDPE) bottles with a child-resistant polypropylene (PP) cap equipped with inner low-density polyethylene (LDPE) desiccant canister containing silica gel.

Each bottle contains 20 or 30 tablets and is enclosed in an outer cardboard carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ

Marketing authorization dates and numbers

PL 00057/0936

14 February 1996

Drugs

Drug Countries
CABASER Australia, Finland, Ireland, Japan, Turkey, United Kingdom

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