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Wakix (pitolisant) – Labelling - N07XX11

Updated on site: 10-Oct-2017

Medication nameWakix
ATC CodeN07XX11
Substancepitolisant
ManufacturerBioprojet Pharma

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Wakix 4.5 mg film-coated tablets

Pitolisant

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet of Wakix 4.5 mg contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30 film-coated 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

Bioprojet Pharma 9, rue Rameau 75002 Paris France

12.MARKETING AUTHORISATION NUMBER

EU/1/15/1068/001

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Wakix 4.5 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Wakix 4.5 mg film-coated tablets

Pitolisant

Oral use

2.METHOD OF ADMINISTRATION

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30tablets

6.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1. NAME OF THE MEDICINAL PRODUCT

Wakix 18 mg film-coated tablets

Pitolisant

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each film-coated tablet of Wakix 18 mg contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 film-coated 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

Bioprojet Pharma 9, rue Rameau 75002 Paris France

12. MARKETING AUTHORISATION NUMBER

EU/1/15/1068/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Wakix 18 mg

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

LABEL

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Wakix 18 mg film-coated tablets

Pitolisant

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

BN

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30tablets

6. OTHER

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