Article Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. STATEMENT OF ACTIVE SUBSTANCE(S)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
- 7. OTHER SPECIAL WARNING(S), IF NECESSARY
- 8. EXPIRY DATE
- 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
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL CLASSIFICATION FOR SUPPLY
- 15. INSTRUCTIONS ON USE
- 16. INFORMATION IN BRAILLE
- 2. NAME OF THE MARKETING AUTHORISATION HOLDER
- 3. EXPIRY DATE
- 4. BATCH NUMBER
- 5. OTHER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1.NAME OF THE MEDICINAL PRODUCT
Raloxifene Teva 60 mg
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each
3.LIST OF EXCIPIENTS
4.PHARMACEUTICAL FORM AND CONTENTS
14
28
84
- Evista - raloxifene hydrochloride
- Optruma - raloxifene hydrochloride
Prescription drugs listed. Substance: "Raloxifene hydrochloride"
5.METHOD AND ROUTE(S) OF ADMINISTRATION
Swallow tablets whole.
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
Do not store above 25°C. Store in the original package to protect from moisture.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
- Nevirapine teva - Teva B.V.
- Lamivudine teva - Teva B.V.
- Myfenax - Teva B.V.
- Zoledronic acid teva - Teva B.V.
- Imatinib teva - Teva B.V.
- Topotecan teva - Teva B.V.
Prescription drugs listed. Manufacturer: "Teva B.V."
11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/10/627/001 14 film coated tablets
EU/1/10/627/002 28 film coated tablets
EU/1/10/627/003 84 film coated tablets
13.BATCH NUMBER
Lot
14.GENERAL CLASSIFICATION FOR SUPPLY
- Optruma - G03XC01
- Evista - G03XC01
Prescription drugs listed. ATC Code: "G03XC01"
Medicinal product subject to medical prescription
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
Raloxifene Teva 60 mg
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
1. NAME OF THE MEDICINAL PRODUCT
Raloxifene Teva 60 mg
2.NAME OF THE MARKETING AUTHORISATION HOLDER
Teva B.V.
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Lot
5.OTHER
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