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Votubia (everolimus) – Labelling - L01XE10

Updated on site: 10-Oct-2017

Medication nameVotubia
ATC CodeL01XE10
Substanceeverolimus
ManufacturerNovartis Europharm Ltd

Article Contents

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Votubia 2.5 mg tablets

Everolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 2.5 mg everolimus.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

10 tablets

30 tablets

100 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

Do not store above 25°C. Store in the original package in order to protect from light and 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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/710/001

10 tablets

 

EU/1/11/710/002

 

30 tablets

 

EU/1/11/710/003

 

100 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Votubia 2.5 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Votubia 2.5 mg tablets

Everolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Votubia 5 mg tablets

Everolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg everolimus.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

30 tablets

100 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

Do not store above 25°C. Store in the original package in order to protect from light and 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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/710/004

30 tablets

 

EU/1/11/710/005

 

100 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Votubia 5 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Votubia 5 mg tablets

Everolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Votubia 10 mg tablets

Everolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg everolimus.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

10 tablets

30 tablets

100 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

Do not store above 25°C. Store in the original package in order to protect from light and 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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/710/006

30 tablets

 

EU/1/11/710/007

 

100 tablets

EU/1/11/710/008

 

10 tablets

 

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Votubia 10 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Votubia 10 mg tablets

Everolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Votubia 2 mg dispersible tablets

Everolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each dispersible tablet contains 2 mg everolimus.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Dispersible tablets

10 dispersible tablets

30 dispersible tablets

100 dispersible tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

The tablets must be dispersed in water before administration.

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

Do not store above 30°C. Store in the original package in order to protect from light and 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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/710/009

10 dispersible tablets

 

EU/1/11/710/010

 

30 dispersible tablets

 

EU/1/11/710/011

 

100 dispersible tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Votubia 2 mg dispersible tablets, abbreviated form accepted, if required for technical reasons

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Votubia 2 mg dispersible tablets

Everolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Votubia 3 mg dispersible tablets

Everolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each dispersible tablet contains 3 mg everolimus.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Dispersible tablets

30 dispersible tablets

100 dispersible tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

The tablets must be dispersed in water before administration.

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

Do not store above 30°C. Store in the original package in order to protect from light and 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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/710/012

30 dispersible tablets

 

EU/1/11/710/013

 

100 dispersible tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Votubia 3 mg dispersible tablets, abbreviated form accepted, if required for technical reasons

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Votubia 3 mg dispersible tablets

Everolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

1.NAME OF THE MEDICINAL PRODUCT

Votubia 5 mg dispersible tablets

Everolimus

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each dispersible tablet contains 5 mg everolimus.

3.LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

Dispersible tablets

30 dispersible tablets

100 dispersible tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

The tablets must be dispersed in water before administration.

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

Do not store above 30°C. Store in the original package in order to protect from light and 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

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/11/710/014

30 dispersible tablets

 

EU/1/11/710/015

 

100 dispersible tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Votubia 5 mg dispersible tablets, abbreviated form accepted, if required for technical reasons

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC:

SN:

NN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Votubia 5 mg dispersible tablets

Everolimus

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

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