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SwedishArticle 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
OUTER CARTON FOR BLISTER
1.NAME OF THE MEDICINAL PRODUCT
Daliresp 500 micrograms
2.STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 500 micrograms roflumilast.
3.LIST OF EXCIPIENTS
Contains lactose. See package leaflet for further information.
4.PHARMACEUTICAL FORM AND CONTENTS
10
30
90
- Daxas - roflumilast
- Libertek - roflumilast
Prescription drugs listed. Substance: "Roflumilast"
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
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
AstraZeneca AB
- Zavicefta - AstraZeneca AB
- Pandemic influenza vaccine h5n1 astrazeneca (pandemic influenza vaccine h5n1 medimmune) - AstraZeneca AB
- Komboglyze - AstraZeneca AB
- Possia - AstraZeneca AB
- Daxas - AstraZeneca AB
- Tagrisso - AstraZeneca AB
Prescription drugs listed. Manufacturer: "AstraZeneca AB"
Sweden
12.MARKETING AUTHORISATION NUMBER(S)
EU/1/11/668/001
EU/1/11/668/002
EU/1/11/668/003
13.BATCH NUMBER
Batch
14.GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.INSTRUCTIONS ON USE
16.INFORMATION IN BRAILLE
- Daxas - R03DX07
Prescription drugs listed. ATC Code: "R03DX07"
Daliresp 500 micrograms
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTERS
1. NAME OF THE MEDICINAL PRODUCT
Daliresp 500 micrograms tablets roflumilast
2.NAME OF THE MARKETING AUTHORISATION HOLDER
AstraZeneca AB
3.EXPIRY DATE
EXP
4.BATCH NUMBER
Batch
5.OTHER
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