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ESTRADOT 50 MICROGRAMS/24 HOURS TRANSDERMAL PATCH

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By mbamarahc at 4:21 pm, 11/17/06
Carton Label Text: ESTRADOT® 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH
8 ESTRADOT® 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH (estradiol)
Transdermal patches for application to the skin
Each patch contains estradiol hemihydrate corresponding to 0.78mg estradiol and releases about 50 micrograms
estradiol per 24 hours.
Also contains Adhesive matrix: acrylic adhesive, silicone adhesive, oleyl alcohol, dipropylene glycol, povidone
(E1201). Backing layer: ethylene/vinyl acetate copolymer, polyethylene, vinylidene/vinyl chloride copolymer,
ethylene/vinyl acetate copolymer co-extruded film. Release liner: fluoropolymer-coated polyester film.
Use as directed by your doctor
Do not refrigerate or freeze. Store in the original package. Patches should not be stored once opened but should
be applied immediately upon removal from the protective sachet.
Read the enclosed leaflet before use.
FOR EXTERNAL USE ONLY
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
POM
Batch: 12345678/x
Exp: DD/MM/YYYY
PL No: 10383/1404
ECMA No: 358 583.4
Manufactured by Norvatis Pharma SAS 26, Rue De La Chapelle, 68330 Huningue France.
Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd., 28 Sarum
Complex, Uxbridge, Middlesex UB8 2RZ

Patch Label Text: ESTRADOT® 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH
ESTRADOT® 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH (estradiol)
Transdermal patches for application to the skin
Each patch contains estradiol hemihydrate corresponding to 0.78mg estradiol and releases about 50 micrograms
estradiol per 24 hours.
Also contains Adhesive matrix: acrylic adhesive, silicone adhesive, oleyl alcohol, dipropylene glycol, povidone
(E1201). Backing layer: ethylene/vinyl acetate copolymer, polyethylene, vinylidene/vinyl chloride copolymer,
ethylene/vinyl acetate copolymer co-extruded film. Release liner: fluoropolymer-coated polyester film.
For application to the Skin. Use as directed by your doctor. Read the enclosed leaflet before use.
FOR EXTERNAL USE ONLY
Do not refrigerate or freeze. Store in the original package
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Primecrown Ltd., 28 Sarum Complex, Uxbridge, Middlesex UB8 2RZ

Braille to be applied as over-label

Estradot
#50 micrograms/
#24 hours

I give an assurance that Braille will conform to the Marburg medium specification without obscuring any statutory information.

Signature:

Joel

Date: 19.10.2006

Carton Label Text: ESTRADIOL 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH
8 ESTRADIOL 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH
Transdermal patches for application to the skin
Each patch contains estradiol hemihydrate corresponding to 0.78mg estradiol and releases about 50 micrograms
estradiol per 24 hours.
Also contains Adhesive matrix: acrylic adhesive, silicone adhesive, oleyl alcohol, dipropylene glycol, povidone
(E1201). Backing layer: ethylene/vinyl acetate copolymer, polyethylene, vinylidene/vinyl chloride copolymer,
ethylene/vinyl acetate copolymer co-extruded film. Release liner: fluoropolymer-coated polyester film.
Use as directed by your doctor
Do not refrigerate or freeze. Store in the original package. Patches should not be stored once opened but should
be applied immediately upon removal from the protective sachet.
Read the enclosed leaflet before use.
FOR EXTERNAL USE ONLY
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
POM
Batch: 12345678/x
Exp: DD/MM/YYYY
PL No: 10383/1404
ECMA No: 358 583.4
Manufactured by Norvatis Pharma SAS 26, Rue De La Chapelle, 68330 Huningue France.
Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd., 28 Sarum
Complex, Uxbridge, Middlesex UB8 2RZ

Patch Label Text: ESTRADIOL 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH
ESTRADIOL 50 MICROGRAMS/24 HOURS, TRANSDERMAL PATCH
Transdermal patches for application to the skin
Each patch contains estradiol hemihydrate corresponding to 0.78mg estradiol and releases about 50 micrograms
estradiol per 24 hours.
Also contains Adhesive matrix: acrylic adhesive, silicone adhesive, oleyl alcohol, dipropylene glycol, povidone
(E1201). Backing layer: ethylene/vinyl acetate copolymer, polyethylene, vinylidene/vinyl chloride copolymer,
ethylene/vinyl acetate copolymer co-extruded film. Release liner: fluoropolymer-coated polyester film.
For application to the Skin. Use as directed by your doctor. Read the enclosed leaflet before use.
FOR EXTERNAL USE ONLY
Do not refrigerate or freeze. Store in the original package
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Primecrown Ltd., 28 Sarum Complex, Uxbridge, Middlesex UB8 2RZ

Braille to be applied as over-label

Estradiol
#50 micrograms/
#24 hours

I give an assurance that Braille will conform to the Marburg medium specification without obscuring any statutory information.

The name VIVELLEDOT will be over labelled on the imported carton.
Signature:

Joel

Date: 19.10.2006

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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