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Ofev (nintedanib) – Labelling - L01XE

Updated on site: 08-Oct-2017

Medication nameOfev
ATC CodeL01XE
Substancenintedanib
ManufacturerBoehringer Ingelheim International GmbH

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer box

1.NAME OF THE MEDICINAL PRODUCT

Ofev 100 mg soft capsules nintedanib

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 100 mg nintedanib (as esilate).

3.LIST OF EXCIPIENTS

Contains soya lecithin. See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

30 x 1 soft capsules

60 x 1 soft capsules

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

Do not store above 25°C.

Store in the original package 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

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/14/979/001

EU/1/14/979/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Ofev 100 mg

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number} [product code] SN: {number} [serial number]

NN: {number} [national reimbursement number or other national number identifying the medicinal product]

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

Outer box

1. NAME OF THE MEDICINAL PRODUCT

Ofev 150 mg soft capsules nintedanib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains 150 mg nintedanib (as esilate).

3. LIST OF EXCIPIENTS

Contains soya lecithin. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 x 1 soft capsules

60 x 1 soft capsules

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

Do not store above 25°C.

Store in the original package 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

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/14/979/003

EU/1/14/979/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Ofev 150 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number} [product code] SN: {number} [serial number]

NN: {number} [national reimbursement number or other national number identifying the medicinal product]

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Ofev 100 mg capsules nintedanib

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim (logo)

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

Do not open before use.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Ofev 150 mg capsules nintedanib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim (logo)

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Do not open before use.

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