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Lojuxta (lomitapide) – Labelling - C10AX12

Updated on site: 08-Oct-2017

Medication nameLojuxta
ATC CodeC10AX12
Substancelomitapide
ManufacturerAegerion Pharmaceuticals

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

CARTON AND BOTTLE (5 mg, 10 mg, 20 mg, 30 mg, 40 mg and 60 mg)

1.NAME OF THE MEDICINAL PRODUCT

Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide. Each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide. Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide. Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide. Each hard capsule contains lomitapide mesylate equivalent to 40 mg lomitapide. Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.

3.LIST OF EXCIPIENTS

Contains lactose.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store below 30°C.

Keep the bottle tightly closed in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Aegerion Pharmaceuticals Ltd

Lakeside House

1 Furzeground Way

Stockley Park East

Uxbridge UB11 1BD

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/13/851/001

EU/1/13/851/002

EU/1/13/851/003

EU/1/13/851/004

EU/1/13/851/005

EU/1/13/851/006

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

lojuxta 5 mg lojuxta 10 mg lojuxta 20 mg lojuxta 30 mg lojuxta 40 mg lojuxta 60 mg

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