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EMEND Capsules (2018)

Active ingredients: Aprepitant

Product Name and Form

EMEND 125 mg hard capsules.

EMEND 80 mg hard capsules.

Pharmaceutical form

Hard capsule.

The 125 mg capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. The 80 mg capsules are opaque with a white body and cap with “461” and “80 mg” printed radially in black ink on the body.

Qualitative and Quantitative Composition

Each 125 mg capsule contains 125 mg of aprepitant. Each 80 mg capsule contains 80 mg of aprepitant.

Excipient with known effect: Each capsule contains 125 mg of sucrose (in the 125 mg capsule).

Excipient with known effect: Each capsule contains 80 mg of sucrose (in the 80 mg capsule).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Aprepitant

Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.

List of excipients

Capsule content:

Sucrose
Microcrystalline cellulose (E460)
Hydroxypropylcellulose (E463)
Sodium laurilsulfate

Capsule shell (125 mg):

Gelatin
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)

Capsule shell (80 mg):

Gelatin
Titanium dioxide (E171)

Printing ink:

Shellac
Potassium hydroxide
Black iron oxide (E172)

Pack sizes and Marketing

Different pack sizes including different strengths are available.

Aluminium blister containing one 80 mg capsule.
Aluminium blister containing two 80 mg capsules.
5 Aluminium blisters each containing one 80 mg capsule.

Aluminium blister containing one 125 mg capsule.
5 Aluminium blisters each containing one 125 mg capsule.

Aluminium blister containing one 125 mg capsule and two 80 mg capsules.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Date of first authorisation: 11 November 2003

Date of latest renewal: 22 September 2008

Marketing authorization number:

EU/1/03/262/001
EU/1/03/262/002
EU/1/03/262/003
EU/1/03/262/004
EU/1/03/262/005
EU/1/03/262/006