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Invega (paliperidone) – Labelling - N05AX13

Updated on site: 08-Oct-2017

Medication nameInvega
ATC CodeN05AX13
Substancepaliperidone
ManufacturerJanssen-Cilag International NV

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR PVC-PCTFE/ALUMINIUM BLISTER (for white and clear blister)

1.NAME OF THE MEDICINAL PRODUCT

INVEGA 1.5 mg prolonged-release tablets paliperidone

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 1.5 mg paliperidone

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

30 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9.SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12.MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/077 - CLEAR

28 prolonged-release tablets - EU/1/07/395/078 - CLEAR

30 prolonged-release tablets - EU/1/07/395/079 - CLEAR

49 prolonged-release tablets - EU/1/07/395/080 - CLEAR

56 prolonged-release tablets - EU/1/07/395/081 - CLEAR

98 prolonged-release tablets - EU/1/07/395/082 – CLEAR

14 prolonged-release tablets - EU/1/07/395/083 - WHITE

28 prolonged-release tablets - EU/1/07/395/084 - WHITE

30 prolonged-release tablets - EU/1/07/395/085 - WHITE

49 prolonged-release tablets - EU/1/07/395/086 - WHITE

56 prolonged-release tablets - EU/1/07/395/087 - WHITE

98 prolonged-release tablets - EU/1/07/395/088 - WHITE

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

invega 1.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 & 10 TABLET PVC-PTFE/ALU BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 1.5 mg prolonged-release tablets paliperidone

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3.EXPIRY DATE

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR OPA-ALUMINIUM-PVC/ALUMINIUM BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 1.5 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 1.5 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/089

28 prolonged-release tablets - EU/1/07/395/090

49 prolonged-release tablets - EU/1/07/395/091

56 prolonged-release tablets - EU/1/07/395/092

98 prolonged-release tablets - EU/1/07/395/093

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 1.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 TABLET OPA-ALU-PVC/ALU BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 1.5 mg prolonged-release tablets paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE CARTON

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 1.5 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 1.5 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/094

350 prolonged-release tablets - EU/1/07/395/095

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 1.5 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 1.5 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 1.5 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/094

350 prolonged-release tablets - EU/1/07/395/095

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 PVC-PCTFE/ALUMINIUM BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 3 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 3 mg paliperidone

3. LIST OF EXCIPIENTS

Lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

30 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/065 - CLEAR

28 prolonged-release tablets - EU/1/07/395/001 - CLEAR

30 prolonged-release tablets - EU/1/07/395/002 - CLEAR

49 prolonged-release tablets - EU/1/07/395/003 - CLEAR

56 prolonged-release tablets - EU/1/07/395/004 - CLEAR

98 prolonged-release tablets - EU/1/07/395/005 - CLEAR

14 prolonged-release tablets - EU/1/07/395/066 - WHITE

28 prolonged-release tablets - EU/1/07/395/021 - WHITE

30 prolonged-release tablets - EU/1/07/395/022 - WHITE

49 prolonged-release tablets - EU/1/07/395/023 - WHITE

56 prolonged-release tablets - EU/1/07/395/024 - WHITE

98 prolonged-release tablets - EU/1/07/395/025 - WHITE

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 3 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 & 10 TABLET PVC-PTFE/ALU BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 3 mg prolonged-release tablets paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR OPA-ALUMINIUM-PVC/ALUMINIUM BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 3 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 3 mg paliperidone

3. LIST OF EXCIPIENTS

Lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/067

28 prolonged-release tablets - EU/1/07/395/041

49 prolonged-release tablets - EU/1/07/395/042

56 prolonged-release tablets - EU/1/07/395/043

98 prolonged-release tablets - EU/1/07/395/044

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 3 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 TABLET OPA-ALU-PVC/ALU BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 3 mg prolonged-release tablets paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE CARTON

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 3 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 3 mg paliperidone

3. LIST OF EXCIPIENTS

Lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/057

350 prolonged-release tablets - EU/1/07/395/058

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 3 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 3 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 3 mg paliperidone

3. LIST OF EXCIPIENTS

Lactose monohydrate.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENT

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/057

350 prolonged-release tablets - EU/1/07/395/058

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 PVC-PCTFE/ALUMINIUM BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 6 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 6 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

30 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/068 - CLEAR

28 prolonged-release tablets - EU/1/07/395/006 - CLEAR

30 prolonged-release tablets - EU/1/07/395/007 - CLEAR

49 prolonged-release tablets - EU/1/07/395/008 - CLEAR

56 prolonged-release tablets - EU/1/07/395/009 - CLEAR

98 prolonged-release tablets - EU/1/07/395/010 - CLEAR

14 prolonged-release tablets - EU/1/07/395/069 - WHITE

28 prolonged-release tablets - EU/1/07/395/026 - WHITE

30 prolonged-release tablets - EU/1/07/395/027 - WHITE

49 prolonged-release tablets - EU/1/07/395/028 - WHITE

56 prolonged-release tablets - EU/1/07/395/029 - WHITE

98 prolonged-release tablets - EU/1/07/395/030 - WHITE

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 6 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

7 & 10 TABLET PVC-PCTFE/ALU BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 6 mg prolonged-release tablets paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR OPA-ALUMINIUM-PVC/ALUMINIUM BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 6 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 6 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/070

28 prolonged-release tablets - EU/1/07/395/045

49 prolonged-release tablets - EU/1/07/395/046

56 prolonged-release tablets - EU/1/07/395/047

98 prolonged-release tablets - EU/1/07/395/048

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 6 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 TABLET OPA-ALU-PVC/ALU BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 6 mg prolonged-release tablets paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE CARTON

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 6 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 6 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/059

350 prolonged-release tablets - EU/1/07/395/060

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 6 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 6 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 6 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/059

350 prolonged-release tablets - EU/1/07/395/060

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 PVC-PCTFE/ALUMINIUM BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 9 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 9 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

30 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/071 - CLEAR

28 prolonged-release tablets - EU/1/07/395/011 - CLEAR

30 prolonged-release tablets - EU/1/07/395/012 - CLEAR

49 prolonged-release tablets - EU/1/07/395/013 - CLEAR

56 prolonged-release tablets - EU/1/07/395/014 - CLEAR

98 prolonged-release tablets - EU/1/07/395/015 - CLEAR

14 prolonged-release tablets - EU/1/07/395/072 - WHITE

28 prolonged-release tablets - EU/1/07/395/031 - WHITE

30 prolonged-release tablets - EU/1/07/395/032 - WHITE

49 prolonged-release tablets - EU/1/07/395/033 - WHITE

56 prolonged-release tablets - EU/1/07/395/034 - WHITE

98 prolonged-release tablets - EU/1/07/395/035 - WHITE

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 9 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

7 & 10 TABLET PVC-PCTFE/ALU BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 9 mg prolonged-release tablets paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR OPA-ALUMINIUM-PVC/ALUMINIUM BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 9 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 9 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/073

28 prolonged-release tablets - EU/1/07/395/049

49 prolonged-release tablets - EU/1/07/395/050

56 prolonged-release tablets - EU/1/07/395/051

98 prolonged-release tablets - EU/1/07/395/052

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 9 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 TABLET OPA-ALU-PVC/ALU BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 9 mg prolonged-release tablets

paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE CARTON

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 9 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 9 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/061

350 prolonged-release tablets - EU/1/07/395/062

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 9 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 9 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 9 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/061

350 prolonged-release tablets - EU/1/07/395/062

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 PVC-PCTFE/ALUMINIUM BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 12 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 12 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged-release tablets

28 prolonged-release tablets

30 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/074 - CLEAR

28 prolonged-release tablets - EU/1/07/395/016 - CLEAR

30 prolonged-release tablets - EU/1/07/395/017 - CLEAR

49 prolonged-release tablets - EU/1/07/395/018 - CLEAR

56 prolonged-release tablets - EU/1/07/395/019 - CLEAR

98 prolonged-release tablets - EU/1/07/395/020 - CLEAR

14 prolonged-release tablets - EU/1/07/395/075 - WHITE

28 prolonged-release tablets - EU/1/07/395/036 - WHITE

30 prolonged-release tablets - EU/1/07/395/037 - WHITE

49 prolonged-release tablets - EU/1/07/395/038 - WHITE

56 prolonged-release tablets - EU/1/07/395/039 - WHITE

98 prolonged-release tablets - EU/1/07/395/040 - WHITE

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 12 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

7 & 10 TABLET PVC-PCTFE/ALU BLISTER (for white and clear blister)

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 12 mg prolonged-release tablets paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON FOR OPA-ALUMINIUM-PVC/ALUMINIUM BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 12 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 12 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 prolonged release tablets

28 prolonged-release tablets

49 prolonged-release tablets

56 prolonged-release tablets

98 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

14 prolonged-release tablets - EU/1/07/395/076

28 prolonged-release tablets - EU/1/07/395/053

49 prolonged-release tablets - EU/1/07/395/054

56 prolonged-release tablets - EU/1/07/395/055

98 prolonged-release tablets - EU/1/07/395/056

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 12 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 7 TABLET OPA-ALU-PVC/ALU BLISTER

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 12 mg prolonged-release tablets paliperidone

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Janssen-Cilag International NV

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOTTLE CARTON

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 12 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 12 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/063

350 prolonged-release tablets - EU/1/07/395/064

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

invega 12 mg

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

INVEGA 12 mg prolonged-release tablets paliperidone

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 12 mg paliperidone

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENT

30 prolonged-release tablets

350 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

Oral use

Swallow whole, do not chew, divide or crush.

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

9. SPECIAL STORAGE CONDITIONS

Do not store above 30oC

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

30 prolonged-release tablets - EU/1/07/395/063

350 prolonged-release tablets - EU/1/07/395/064

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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