DDAVP MELT Oral lyophilisate Ref.[7949] Active ingredients: Desmopressin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Product name and form

DDAVP Melt 60 micrograms oral lyophilisate.

DDAVP Melt 120 micrograms oral lyophilisate.

DDAVP Melt 240 micrograms oral lyophilisate.

Pharmaceutical Form

Oral lyophilisate.

DDAVP Melt 60 micrograms oral lyophilisate: White, round, oral lyophilisate marked with a drop shaped figure on one side.

DDAVP Melt 120 micrograms oral lyophilisate: White, round, oral lyophilisate marked with two drop shaped figures on one side.

DDAVP Melt 240 micrograms oral lyophilisate: White, round, oral lyophilisate marked with three drop shaped figure on one side.

Qualitative and quantitative composition

Each unit contains 60, 120 or 240 micrograms desmopressin (as acetate).

For excipients, see 6.1.

Active Ingredient Description
Desmopressin

Desmopressin is a structural analogue of vasopressin in which the antidiuretic activity has been enhanced by the order of 10, while the vasopressor effect has been reduced by the order of 1500. The clinical advantage of this highly changed ratio of antidiuretic to vasopressor effect is that clinically active antidiuretic doses are far below the threshold for a vasopressor effect.

List of Excipients

Gelatin
Mannitol
Citric acid, anhydrous

Pack sizes and marketing

PVC/Polyamide/Aluminium/Polyamide/PVC blisters. Top foil consists of Paper/Polyester teraphthalate/Aluminium/heat seal lacquer. Strips of 10 oral lyophilisates in packs of 100 oral lyophilisates.

Marketing authorization holder

Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Marketing authorization dates and numbers

DDAVP Melt 60 micrograms oral lyophilisate PL 03194/0091
DDAVP Melt 120 micrograms oral lyophilisate PL 03194/0092
DDAVP Melt 240 micrograms oral lyophilisate PL 03194/0093

19th January 2006

Drugs

Drug Countries
DDAVP Brazil, Canada, Ireland, United Kingdom, United States, South Africa

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