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Mimpara (cinacalcet) – Labelling - H05BX01

Updated on site: 08-Oct-2017

Medication nameMimpara
ATC CodeH05BX01
Substancecinacalcet
ManufacturerAmgen Europe B.V.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Mimpara 30 mg film-coated tablets

Cinacalcet

2.STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 30 mg of cinacalcet (as hydrochloride).

3.LIST OF EXCIPIENTS

Lactose monohydrate.

4.PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

84 tablets

5.METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12.MARKETING AUTHORISATION NUMBERS

EU/1/04/292/001 – carton of 14 tablets

EU/1/04/292/002 – carton of 28 tablets

EU/1/04/292/003 – carton of 84 tablets

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

mimpara 30

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 30 mg tablet

Cinacalcet

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 30 mg film-coated tablets

Cinacalcet

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 30 mg of cinacalcet (as hydrochloride).

3. LIST OF EXCIPIENTS

Lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

One bottle containing 30 tablets.

5. METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/04/292/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

mimpara 30

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 30 mg film-coated tablets

Cinacalcet

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 30 mg of cinacalcet (as hydrochloride).

3. LIST OF EXCIPIENTS

Lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

5. METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/04/292/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 60 mg film-coated tablets

Cinacalcet

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 60 mg of cinacalcet (as hydrochloride).

3. LIST OF EXCIPIENTS

Lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

84 tablets

5. METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/04/292/005 – carton of 14 tablets

EU/1/04/292/006 – carton of 28 tablets

EU/1/04/292/007 – carton of 84 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

mimpara 60

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 60 mg tablet

Cinacalcet

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 60 mg film-coated tablets

Cinacalcet

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 60 mg of cinacalcet (as hydrochloride).

3. LIST OF EXCIPIENTS

Lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

One bottle containing 30 tablets.

5. METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/04/292/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

mimpara 60

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 60 mg film-coated tablets

Cinacalcet

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 60 mg of cinacalcet (as hydrochloride).

3. LIST OF EXCIPIENTS

Lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

5. METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/04/292/008

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 90 mg film-coated tablets

Cinacalcet

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 90 mg of cinacalcet (as hydrochloride).

3. LIST OF EXCIPIENTS

Lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

14 tablets

28 tablets

84 tablets

5. METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBERS

EU/1/04/292/009 – carton of 14 tablets

EU/1/04/292/010 – carton of 28 tablets

EU/1/04/292/011 – carton of 84 tablets

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

mimpara 90

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 90 mg tablet

Cinacalcet

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Amgen Europe B.V.

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 90 mg film-coated tablets

Cinacalcet

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 90 mg of cinacalcet (as hydrochloride).

3. LIST OF EXCIPIENTS

Lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

One bottle containing 30 tablets.

5. METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/04/292/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

mimpara 90

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Mimpara 90 mg film-coated tablets

Cinacalcet

2. STATEMENT OF ACTIVE SUBSTANCE

Each tablet contains 90 mg of cinacalcet (as hydrochloride).

3. LIST OF EXCIPIENTS

Lactose monohydrate.

4. PHARMACEUTICAL FORM AND CONTENTS

30 tablets

5. METHOD AND ROUTE OF ADMINISTRATION

For 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

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

The Netherlands

12. MARKETING AUTHORISATION NUMBER

EU/1/04/292/012

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

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