Miscellaneous ePI Test
0.1.0 - CI Build

Miscellaneous ePI Test, published by . This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-test/ and changes regularly. See the Directory of published versions

Bundle: Talzenna® (talazoparib) 0.25 mg and 1 mg hard capsules (Bundle)

Composition category:
Composition status: final


Narrative Text


PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 0.1 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 0.1 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Swallow whole. Do not open, crush or chew the capsules.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/007 (30 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Talzenna 0.1 mg

17. UNIQUE IDENTIFIER - 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

NN

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 0.1 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 0.1 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use. Swallow whole.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/007 (30 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER - 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 0.25 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Swallow whole. Do not open, crush or chew the capsules.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/001 (30 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Talzenna 0.25 mg

17. UNIQUE IDENTIFIER - 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

NN

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 0.25 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use. Swallow whole.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/001 (30 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER - 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 0.25 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use. Swallow whole.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/001 (30 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER - 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 0.25 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 × 1 capsules

60 × 1 capsules

90 × 1 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Swallow whole. Do not open, crush or chew the capsules.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/002 (30 hard capsules)

EU/1/19/1377/003 (60 hard capsules)

EU/1/19/1377/004 (90 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Talzenna 0.25 mg

17. UNIQUE IDENTIFIER - 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

NN

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 0.25 mg hard capsules

talazoparib

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Pfizer

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 1 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

Swallow whole. Do not open, crush or chew the capsules.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/005 (30 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Talzenna 1 mg

17. UNIQUE IDENTIFIER - 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

NN

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 1 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use. Swallow whole.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/005 (30 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Talzenna 1 mg

17. UNIQUE IDENTIFIER - 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC

SN

NN

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Talzenna 1 mg hard capsules

talazoparib

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

Hard capsule

30 capsules

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use. Swallow whole.

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

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/19/1377/005 (30 hard capsules)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER - 2D BARCODE

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER OUTER CARTON

Product Information

Talzenna® (talazoparib) 0.25 mg hard capsules

WWW.MHRA.GOV.UK: 471bb15-7f52-4fcd-b615-8674ce6eb91e

status: active

Domain: Human use

Combined pharmaceutical dose form:

Legal Status of Supply: Medicinal product subject to medical prescription

Authorisation 2 of 2

Auth id: 6ae5b5d9-7372-494c-874b-7dc67d386d2e

Region: United Kingdom

Type: Marketing Authorisation

Holder: Pfizer Limited (ORG-100000789)

Status: Active (2022-03-01T00:00:00Z)

Package 1 of 6

PMSWI: b42ab299-e84b-4be3-bdbb-a66cd4c8c6ab

Description:

Marketing Status: active

Contained Quantity:

  • 0.25 mg


Package: 30 Blister [PolyVinyl Chloride]

Package 2 of 6

PMSWI: 9aec5a08-17f6-44f0-bd7b-c75fcff62628

Description:

Marketing Status: active

Contained Quantity:

  • 0.25 mg


Package: 60 Blister [PolyVinyl Chloride]

Package 3 of 6

PMSWI: 11967e26-c2d5-46aa-a51f-21a0f9c7bfd0

Description:

Marketing Status: active

Contained Quantity:

  • 0.25 mg


Package: 90 Blister [PolyVinyl Chloride]

Package 4 of 6

PMSWI: 2f8c49a7-e592-43ae-b802-55557bd20470

Description:

Marketing Status: active

Contained Quantity:

  • 0.25 mg


Package: 30 Bottle [PolyVinyl Chloride]

Package 5 of 6

Package 6 of 6

Administrable Product (1 of 2)

Dose form: Capsule, hard

Presentation unit: Capsule

Contents (Manuf. Items):
    mid025mg

    Dose form: Capsule, hard

    Presentation unit: Capsule

    Manufactured Dose Form: Capsule, hard

    Ingredients:
      talazoparib025mg

      Status: Active

      Role: Active

      Substance: TALAZOPARIB

Route of administration:
  • Oral use

Clinical Information

Interaction: Amiodarone

Interaction: carvedilol

Interaction: dronedarone

Interaction: propafenone

Interaction: quinidine

Interaction: ranolazine

Interaction: verapamil

Interaction: Clarithromycin

Interaction: erythromycin

Interaction: Itraconazole

Interaction: ketoconazole

Interaction: Cobicistat

Interaction: darunavir

Interaction: indinavir

Interaction: lopinavir

Interaction: ritonavir

Interaction: saquinavir

Interaction: telaprevir

Interaction: tipranavir

Interaction: Ciclosporin

Interaction: Lapatinib

Interaction: Curcumin

Interaction: Carbamazepine

Interaction: phenytoin

Interaction: St. John’s wort (Hypericum perforatum)

Interaction: turmeric root