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Olanzapine Apotex (olanzapine) – Labelling - N05AH03

Updated on site: 08-Oct-2017

Medication nameOlanzapine Apotex
ATC CodeN05AH03
Substanceolanzapine
ManufacturerApotex Europe B.V.  

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 2.5 mg film-coated tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 2.5 mg olanzapine.

3.LIST OF EXCIPIENTS

Contains lactose.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/635/001

13.BATCH NUMBER

BN

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Olanzapine Apotex 2.5 mg film-coated tablet

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 2.5 mg film-coated tablets

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Apotex Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 5 mg film-coated tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg olanzapine.

3.LIST OF EXCIPIENTS

Contains lactose.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

56 film-coated tablets

98 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/635/002-003

EU/1/10/635/015

13.BATCH NUMBER

BN

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Olanzapine Apotex 5 mg film-coated tablet

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 5 mg film-coated tablets

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Apotex Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 7.5 mg film-coated tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 7.5 mg olanzapine.

3.LIST OF EXCIPIENTS

Contains lactose.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

56 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/635/004-005

13.BATCH NUMBER

BN

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Olanzapine Apotex 7.5 mg film-coated tablet

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 7.5 mg film-coated tablets

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Apotex Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 10 mg film-coated tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg olanzapine.

3.LIST OF EXCIPIENTS

Contains lactose.

See package leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

28 film-coated tablets

56 film-coated tablets

98 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

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

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/635/006-007

EU/1/10/635/016

13.BATCH NUMBER

BN

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Olanzapine Apotex 10 mg film-coated tablet

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 10 mg film-coated tablets

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Apotex Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 5 mg orodispersible tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg olanzapine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28 orodispersible tablets

56 orodispersible tablets

98 orodispersible tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use.

Place the tablet in your mouth. It will quickly dissolve with your saliva and can be swallowed.

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/635/008-009

EU/1/10/635/017

13.BATCH NUMBER

BN

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Olanzapine Apotex 5 mg orodispersible tablet

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 5 mg orodispersible tablets

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Apotex Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 10 mg orodispersible tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg olanzapine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28 orodispersible tablets

56 orodispersible tablets

98 orodispersible tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use.

Place the tablet in your mouth. It will quickly dissolve with your saliva and can be swallowed.

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/635/010-011

EU/1/10/635/018

13.BATCH NUMBER

BN

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Olanzapine Apotex 10 mg orodispersible tablet

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 10 mg orodispersible tablets

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Apotex Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 15 mg orodispersible tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 15 mg olanzapine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28 orodispersible tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use.

Place the tablet in your mouth. It will quickly dissolve with your saliva and can be swallowed.

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/635/012

13.BATCH NUMBER

BN

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Olanzapine Apotex 15 mg orodispersible tablet

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 15 mg orodispersible tablets

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Apotex Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON BOX

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 20 mg orodispersible tablets olanzapine

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 20 mg olanzapine.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

28 orodispersible tablets

56 orodispersible tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Read the package leaflet before use.

Place the tablet in your mouth. It will quickly dissolve with your saliva and can be swallowed.

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

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/10/635/013-014

13.BATCH NUMBER

BN

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Olanzapine Apotex 20 mg orodispersible tablet

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING BLISTER PACK

1.NAME OF THE MEDICINAL PRODUCT

Olanzapine Apotex 20 mg orodispersible tablets

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Apotex Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

BN

5.OTHER

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