ELDEPRYL Tablet Ref.[7934] Active ingredients: Selegiline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Orion Corporation, Orionintie 1, FIN-02200, Espoo, Finland

Product name and form

Eldepryl 5 mg Tablets.

Pharmaceutical Form

Tablets for oral administration.

Qualitative and quantitative composition

Selegiline hydrochloride 5 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Selegiline

Selegiline is a selective MAO-B-inhibitor which prevents dopamine breakdown in the brain. It also inhibits the reuptake of dopamine at the presynaptic dopamine receptor. These effects potentiate dopaminergic function in the brain and help to even out and prolong the effect of exogenous and endogenous dopamine. Thus, selegiline potentiates and prolongs the effect of levodopa in the treatment of parkinsonism.

List of Excipients

Mannitol
Maize starch
Microcrystalline cellulose
Povidone
Magnesium stearate

Pack sizes and marketing

a) White HDPE bottle with LDPE snap cap: 100 tablets.

b) AI/AI blister packs: 30, 50, 60 and 100 tablets.

c) White HDPE bottle with HDPE screw cap: 100 tablets.

Marketing authorization holder

Orion Corporation, Orionintie 1, FIN-02200, Espoo, Finland

Marketing authorization dates and numbers

PL 27925/0004

Date of first authorization: 01 July 1993
Date of latest renewal: July 2007

Drugs

Drug Countries
ELDEPRYL Australia, Finland, Ireland, Malta, United Kingdom, South Africa

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