Myalepta (metreleptin): inconsistencies in the package leaflet
About
This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.
Documents
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8mg vial: inconsistency in the Spanish language package leaflet (PDF/285.44 KB)
First published: 18/06/2020
Dissemination date: 18/06/2020 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: inconsistency in the Portuguese-language package leaflet (PDF/300.99 KB)
First published: 18/06/2020
Dissemination date: 18/06/2020 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 3 mg vial: inconsistency in the Portuguese-language package leaflet (PDF/355.26 KB)
First published: 18/06/2020
Dissemination date: 18/06/2020 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 3 mg vial: inconsistency in the Spanish language package leaflet (PL) (PDF/303.48 KB)
First published: 18/06/2020
Dissemination date: 18/06/2020 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: inconsistency in the English-language package leaflet (PL) (PDF/239.04 KB)
First published: 18/06/2020
Dissemination date: 18/06/2020
Key facts
Medicine name |
Myalepta
|
Active substance |
Metreleptin
|
Therapeutic area (MeSH) |
Lipodystrophy, Familial Partial
|
Procedure number |
EMEA/H/C/004218
|
DHPC type |
Quality defect
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Human ATC code |
A16AA
|
Dissemination date |
18/06/2020
|