Aknemycin
Poland
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. ACTIVE SUBSTANCE CONTENT
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGING CONTENTS
- 5. METHOD AND ROUTE OF ADMINISTRATION
- 6. WARNING REGARDING STORAGE OF THE MEDICINAL PRODUCT
- 7. OTHER SPECIAL WARNINGS, IF NECESSARY
- 8. EXPIRY DATE
- 9. STORAGE CONDITIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
- 11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
- 12. MARKETING AUTHORISATION NUMBERS
- 13. BATCH NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
- 17. UNIQUE IDENTIFIER – 2D CODE
- 18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
- 19. OTHER INFORMATION
INFORMATION ON OUTER PACKAGING
LABEL ON OUTER PACKAGING
1. NAME OF THE MEDICINAL PRODUCT
Aknemycin
20 mg/g, topical solution
Erythromycinum
2. ACTIVE SUBSTANCE CONTENT
1 g of topical solution contains 20 mg of erythromycin.
3. LIST OF EXCIPIENTS
Excipients: ethanol, lauryl polyglyceryl phosphate, glycerol, povidone K 30.
More information in the package leaflet.
4. PHARMACEUTICAL FORM AND PACKAGING CONTENTS
topical solution
25 ml of topical solution GTIN number: 5909997222738
5. METHOD AND ROUTE OF ADMINISTRATION
For topical use.
Read the instruction leaflet carefully before using the medicine.
6. WARNING REGARDING STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
Flammable product.
Additional information – see the leaflet.
Caution! Keep the leaflet! Information on the immediate packaging in a foreign language.
8. EXPIRY DATE
Do not use more than 6 months after first opening the container.
EXP:
Expiry date – Use by
9. STORAGE CONDITIONS
Do not store above 25°C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE MATERIAL DERIVING FROM SUCH MEDICINAL
PRODUCT, IF APPROPRIATE
11. NAME AND ADDRESS OF THE RESPONSIBLE ENTITY
Responsible entity in Germany, the country of export:
Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Germany
12. MARKETING AUTHORISATION NUMBERS
Authorisation number in Germany, the exporting country: 2684.00.00
Parallel import authorisation number: 162/13
13. BATCH NUMBER
Lot:
Batch number – Ch.-B.
14. GENERAL AVAILABILITY CATEGORY
Rp - Medicinal product available by prescription only.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE
Aknemycin solution for skin application
17. UNIQUE IDENTIFIER – 2D CODE
Includes a 2D code serving as the carrier of the unique identifier.
18. UNIQUE IDENTIFIER – HUMAN-READABLE DATA
PC: 05909997222738
SN:
NN:
19. OTHER INFORMATION
Manufacturer:
Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Approved: 27.02.2025