NIMVASTID Hard capsule Ref.[27736] Active ingredients: Rivastigmine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Nimvastid 1.5 mg hard capsules.
Nimvastid 3 mg hard capsules.
Nimvastid 4.5 mg hard capsules.
Nimvastid 6 mg hard capsule.

Pharmaceutical Form

Hard capsule.

Nimvastid 1.5 mg hard capsules: White to almost white powder in a capsule with yellow cap and yellow body.

Nimvastid 3 mg hard capsules: White to almost white powder in a capsule with orange cap and orange body.

Nimvastid 4.5 mg hard capsules: White to almost white powder in a capsule with brownish red cap and brownish red body.

Nimvastid 6 mg hard capsules: White to almost white powder in a capsule with a brownish red cap and orange body.

Qualitative and quantitative composition

Nimvastid 1.5 mg hard capsules: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 1.5 mg rivastigmine.

Nimvastid 3 mg hard capsules: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 3 mg rivastigmine.

Nimvastid 4.5 mg hard capsules: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 4.5 mg rivastigmine.

Nimvastid 6 mg hard capsules: Each hard capsule contains rivastigmine hydrogen tartrate equivalent to 6 mg rivastigmine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rivastigmine

Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones. Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’s disease and Parkinson’s disease.

List of Excipients

Capsule content:

Microcrystalline cellulose
Hypromellose
Silica, colloidal anhydrous
Magnesium stearate

Capsule shell:

Titanium dioxide (E171)
Yellow iron oxide (E172)
Gelatine

Pack sizes and marketing

Blister pack (PVC/PVDC/Alu-foil): 14, 28, 30, 56, 60 or 112 hard capsules in a box.

HDPE container: 200 or 250 hard capsules in a box.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

14 hard capsules: EU/1/09/525/001
28 hard capsules: EU/1/09/525/002
30 hard capsules: EU/1/09/525/003
56 hard capsules: EU/1/09/525/004
60 hard capsules: EU/1/09/525/005
112 hard capsules: EU/1/09/525/006
200 hard capsules: EU/1/09/525/047
250 hard capsules: EU/1/09/525/007

Date of first authorisation: 11/5/2009
Date of latest renewal: DD month YYYY

Drugs

Drug Countries
NIMVASTID Austria, Cyprus, Germany, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom

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