English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Galafold (migalastat hydrochloride) – Labelling - Amicus Therapeu

Updated on site: 07-Oct-2017

Medication nameGalafold
ATC CodeAmicus Therapeu
Substancemigalastat hydrochloride
ManufacturerAuthorised

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1.NAME OF THE MEDICINAL PRODUCT

Galafold 123 mg hard capsules migalastat

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

14 hard capsules

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Take on an empty stomach, at least 2 hours before or after food intake, at the same time each day. Swallow the capsule whole. Do not cut, crush, or chew the capsule.

Read the package leaflet before use. Oral use.

Take Galafold capsule every other day and punch out the perforated circle on the blister sleeve on the days you are not taking Galafold.

Instructions to open

1.PRESS and hold tab at the left

2.PULL out card on the right

3.PUSH capsule through the foil

4.PUSH card back into holder

To access the package leaflet, scan the code below.

QR code to be included + www.galafoldsmpc.co.uk

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 in the original package 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

Amicus Therapeutics UK Ltd

Phoenix House,

Oxford Road,

Tatling End,

Gerrards Cross,

Buckinghamshire

SL9 7AP

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/15/1082/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

galafold 123 mg hard capsules

MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING

BLISTER SLEEVE

1. NAME OF THE MEDICINAL PRODUCT

Galafold 123 mg hard capsules migalastat

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Amicus Therapeutics UK, Ltd

3.EXPIRY DATE

EXP:

4.BATCH NUMBER

LOT:

5.OTHER

See package leaflet for further instructions.

Punch out the perforated circles on days you are not taking Galafold. Galafold is to be taken every other day.

Starting date:

MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING

BLISTER FOIL

1. NAME OF THE MEDICINAL PRODUCT

2. NAME OF THE MARKETING AUTHORISATION HOLDER

3. EXPIRY DATE

4. BATCH NUMBER

LOT:

5. OTHER

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed