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Wilzin (zinc) – Labelling - A16AX05

Updated on site: 10-Oct-2017

Medication nameWilzin
ATC CodeA16AX05
Substancezinc
ManufacturerOrphan Europe S.A.R.L.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE

PACKAGING

OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 25 mg hard capsules)

1.NAME OF THE MEDICINAL PRODUCT

Wilzin 25 mg hard capsules

Zinc

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate).

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

250 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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/286/001

13.MANUFACTURER’S BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION ON BRAILLE

Wilzin 25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE

PACKAGING

OUTER CARTON BOX AND BOTTLE LABEL (Wilzin 50 mg hard capsules)

1.NAME OF THE MEDICINAL PRODUCT

Wilzin 50 mg hard capsules

Zinc

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each hard capsule contains 50 mg of zinc (corresponding to 167.84 mg of zinc acetate dihydrate) .

3.LIST OF EXCIPIENTS

Contains E110. See the package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

250 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 REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 25°C.

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

Orphan Europe SARL

Immeuble “Le Wilson”

70, avenue du Général de Gaulle F-92800 Puteaux

France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/04/286/002

13.MANUFACTURER’S BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION ON BRAILLE

Wilzin 50 mg

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