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Kuvan (sapropterin dihydrochloride) – Labelling - A16AX07

Updated on site: 08-Oct-2017

Medication nameKuvan
ATC CodeA16AX07
Substancesapropterin dihydrochloride
ManufacturerBioMarin International Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

CARTON AND BOTTLE LABEL

1.NAME OF THE MEDICINAL PRODUCT

Kuvan 100 mg soluble tablets

Sapropterin dihydrochloride

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each soluble tablet contains 100 mg of sapropterin dihydrochloride (equivalent to 77 mg of sapropterin).

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

30 soluble tablets

120 soluble tablets

240 soluble tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use, after dissolution.

Read the package leaflet before 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

Each bottle of Kuvan contains a small plastic tube of desiccant (silica gel). Do not swallow the tube or the contents.

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store below 25°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

BioMarin International Limited

Shanbally, Ringaskiddy

County Cork

Ireland

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/481/001

EU/1/08/481/002

EU/1/08/481/003

13.BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

kuvan

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