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Neofordex (dexamethasone) – Labelling - H02AB02

Updated on site: 08-Oct-2017

Medication nameNeofordex
ATC CodeH02AB02
Substancedexamethasone
ManufacturerLaboratoires CTRS 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Neofordex 40 mg tablets dexamethasone

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains dexamethasone acetate equivalent to 40 mg dexamethasone.

3.LIST OF EXCIPIENTS

Contains lactose. See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

10 x 1 tablets

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

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

Laboratoires CTRS 63, rue de l’Est

92100 Boulogne-Billancourt France

Email: ctrs@ctrs.fr

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1053/001

13.BATCH NUMBER

LOT

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

neofordex

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Neofordex 40 mg tablet dexamethasone

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Laboratoires CTRS

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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