NORPROLAC Tablet Ref.[9743] Active ingredients: Quinagolide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Product name and form

NORPROLAC 25 micrograms Tablets.

Quinagolide 25 micrograms Tablets.

Pharmaceutical Form

Tablet for oral administration.

Qualitative and quantitative composition

Quinagolide, as the hydrochloride, 25 micrograms.

Active Ingredient Description
Quinagolide

Quinagolide is a selective dopamine D2-receptor agonist not belonging to the chemical classes of ergot or ergoline compounds. Owing to its dopaminergic action, the drug exerts a strong inhibitory effect on the secretion of the anterior pituitary hormone prolactin, but does not reduce normal levels of other pituitary hormones.

List of Excipients

Iron oxide
Red, silica, colloidal anhydrous
Magnesium stearate
Methylhydroxypropylcellulose
Maize starch
Cellulose
Microcrystalline
Lactose

Pack sizes and marketing

The ‘starter pack’ (NORPROLAC 25/50) consists of 3 tablets of 25 micrograms and 3 tablets of 50 micrograms. These tablets are packed in an aluminium PVC/PVDC blister which is sealed in a moisture proof aluminium bag.

Marketing authorization holder

Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom

Marketing authorization dates and numbers

PL 35533/0062

15th December 2004

Drugs

Drug Countries
NORPROLAC Austria, Australia, Canada, Cyprus, Spain, France, Hong Kong, Mexico, Netherlands, Poland, United Kingdom, South Africa

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