English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Oprymea (pramipexole dihydrochloride monohydrate) – Labelling - N04BC05

Updated on site: 09-Oct-2017

Medication nameOprymea
ATC CodeN04BC05
Substancepramipexole dihydrochloride monohydrate
ManufacturerKrka, d.d., Novo mesto

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1.NAME OF THE MEDICINAL PRODUCT

Oprymea 0.088 mg tablets

Pramipexole

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 0.088 mg pramipexole (as 0.125 mg pramipexole dihydrochloride monohydrate).

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

Tablet

20 tablets

30 tablets

60 tablets

90 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

Store in the original package in order to protect from light.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/001[20 tablets]

EU/1/08/469/002 [30 tablets]

EU/1/08/469/003 [60 tablets]

EU/1/08/469/004 [90 tablets]

EU/1/08/469/005 [100 tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.088 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER/(Alu/Alu)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.088 mg tablets

Pramipexole

2.NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.18 mg tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 0.18 mg pramipexole (as 0.25 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

20 tablets

30 tablets

60 tablets

90 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

Store in the original package in order to protect from light.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/006 [20 tablets]

EU/1/08/469/007 [30 tablets]

EU/1/08/469/008 [60 tablets]

EU/1/08/469/009 [90 tablets]

EU/1/08/469/010 [100 tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.18 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER/(Alu/Alu)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.18 mg tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.35 mg tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 0.35 mg pramipexole (as 0.5 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

20 tablets

30 tablets

60 tablets

90 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

Store in the original package in order to protect from light.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/011 [20 tablets]

EU/1/08/469/012 [30 tablets]

EU/1/08/469/013 [60 tablets]

EU/1/08/469/014 [90 tablets]

EU/1/08/469/015 [100 tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.35 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER/(Alu/Alu)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.35 mg tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.7 mg tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 0.7 mg pramipexole (as 1 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

20 tablets

30 tablets

60 tablets

90 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

Store in the original package in order to protect from light.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/016 [20 tablets]

EU/1/08/469/017 [30 tablets]

EU/1/08/469/018 [60 tablets]

EU/1/08/469/019 [90 tablets]

EU/1/08/469/020 [100 tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.7 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER/(Alu/Alu)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.7 mg tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 1.1 mg tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 1.1 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Tablet

20 tablets

30 tablets

60 tablets

90 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

Store in the original package in order to protect from light.

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/021 [20 tablets]

EU/1/08/469/022 [30 tablets]

EU/1/08/469/023 [60 tablets]

EU/1/08/469/024 [90 tablets]

EU/1/08/469/025 [100 tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 1.1 mg

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTER/(Alu/Alu)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 1.1 mg tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.26 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

10 prolonged-release tablets

30 prolonged-release tablets

90 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/026 [10 prolonged-release tablets]

EU/1/08/469/027 [30 prolonged-release tablets]

EU/1/08/469/028 [90 prolonged-release tablets]

EU/1/08/469/029 [100 prolonged-release tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.26 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.26 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.52 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

10 prolonged-release tablets

30 prolonged-release tablets

90 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/030 [10 prolonged-release tablets]

EU/1/08/469/031[30 prolonged-release tablets]

EU/1/08/469/032[90 prolonged-release tablets]

EU/1/08/469/033[100 prolonged-release tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.52 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.52 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 1.05 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 1.05 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

10 prolonged-release tablets

30 prolonged-release tablets

90 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/034 [10 prolonged-release tablets]

EU/1/08/469/035 [30 prolonged-release tablets]

EU/1/08/469/036 [90 prolonged-release tablets]

EU/1/08/469/037 [100 prolonged-release tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 1.05 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 1.05 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 1.57 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 1.57 mg pramipexole (as 2.25 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

10 prolonged-release tablets

30 prolonged-release tablets

90 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/038 [10 prolonged-release tablets]

EU/1/08/469/039 [30 prolonged-release tablets]

EU/1/08/469/040 [90 prolonged-release tablets]

EU/1/08/469/041 [100 prolonged-release tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 1.57 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 1.57 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 2.1 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 2.1 mg pramipexole (as 3 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

10 prolonged-release tablets

30 prolonged-release tablets

90 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/042 [10 prolonged-release tablets]

EU/1/08/469/043 [30 prolonged-release tablets]

EU/1/08/469/044 [90 prolonged-release tablets]

EU/1/08/469/045 [100 prolonged-release tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 2.1 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 2.1 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 2.62 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 2.62 mg pramipexole (as 3.75 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

10 prolonged-release tablets

30 prolonged-release tablets

90 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/046 [10 prolonged-release tablets]

EU/1/08/469/047 [30 prolonged-release tablets]I

EU/1/08/469/048 [90 prolonged-release tablets]

EU/1/08/469/049 [100 prolonged-release tablets]

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Oprymea 2.62 mg prolonged-release tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18.UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 2.62 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

BOX for blisters

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 3.15 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 3.15 mg pramipexole (as 4.5 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

10 prolonged-release tablets

30 prolonged-release tablets

90 prolonged-release tablets

100 prolonged-release tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/050 [10 prolonged-release tablets]

EU/1/08/469/051 [30 prolonged-release tablets]

EU/1/08/469/052 [90 prolonged-release tablets]

EU/1/08/469/053 [100 prolonged-release tablets]

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 3.15 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 3.15 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

TREATMENT INITIATION PACK ONLY

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER BOX (treatment initiation pack containing 3 boxes of 7 prolonged-release tablets)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.26 mg Oprymea 0.52 mg Oprymea 1.05 mg prolonged-release tablets Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Oprymea 0.26 mg: Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).

Oprymea 0.52 mg: Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).

Oprymea 1.05 mg: Each prolonged-release tablet contains 1.05 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

Treatment initiation pack

Each pack of 21 prolonged-release tablets for a 3-week treatment schedule contains: 7 tablets of Oprymea 0.26 mg

7 tablets of Oprymea 0.52 mg

7 tablets of Oprymea 1.05 mg

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/054

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.26 mg Oprymea 0.52 mg Oprymea 1.05 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<2D barcode carrying the unique identifier included.>

Safety features will be implemented until 9/2/2019.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<PC:

SN:

NN:>

Safety features will be implemented until 9/2/2019.

TREATMENT INITIATION PACK ONLY

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INNER BOX (week 1)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.26 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

7 prolonged-release tablets Week 1

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/054

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.26 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<Not applicable.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<Not applicable.>

TREATMENT INITIATION PACK ONLY

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister (week 1)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.26 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Week 1

TREATMENT INITIATION PACK ONLY

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INNER BOX (week 2)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.52 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

7 prolonged-release tablets Week 2

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/054

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 0.52 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<Not applicable.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<Not applicable.>

TREATMENT INITIATION PACK ONLY

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister (week 2)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 0.52 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Week 2

TREATMENT INITIATION PACK ONLY

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

INNER BOX (week 3)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 1.05 mg prolonged-release tablets

Pramipexole

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each prolonged-release tablet contains 1.05 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Prolonged-release tablet

7 prolonged-release tablets Week 3

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use

Once daily.

Swallow whole, do not chew, divide or crush.

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

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

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/08/469/054

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Oprymea 1.05 mg prolonged-release tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

<Not applicable.>

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

<Not applicable.>

TREATMENT INITIATION PACK ONLY

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister (week 3)

1. NAME OF THE MEDICINAL PRODUCT

Oprymea 1.05 mg prolonged-release tablets

Pramipexole

2. NAME OF THE MARKETING AUTHORISATION HOLDER

KRKA

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

Week 3

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed