CAMCEVI Prolonged-release suspension for injection Ref.[50038] Active ingredients: Leuprorelin

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039, Barcelona, Spain

Product name and form

CAMCEVI 42 mg prolonged-release suspension for injection.

Pharmaceutical Form
Prolonged-release suspension for injection. Pre-filled syringe with off-white to pale yellow viscous and opalescent suspension.

Qualitative and quantitative composition

Each pre-filled syringe with prolonged-release suspension for injection contains leuprorelin mesilate equivalent to 42 mg leuprorelin.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Leuprorelin	Leuprorelin is inactive when given orally due to poor membrane permeability and an almost complete inactivation by intestinal proteolytic enzymes. Leuprorelin has potent LHRH agonist properties when given during short-term and intermittent therapy, however, when administered in a continuous, nonpulsatile manner, LHRH analogs induce inhibition of gonadotropin secretion and suppression of testicular steroidogenesis.

List of Excipients
Poly(D,L-lactide) N-methylpyrrolidone

Pack sizes and marketing

One pack contains: 1 pre-filled syringe (cyclic olefin copolymer, closed with bromobutyl elastomeric grey tip cap, plunger and finger grip), 1 needle (18 gauge, 5/8 inch) and 1 Point-Lok needle protection device.

Marketing authorization holder

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039, Barcelona, Spain

Marketing authorization dates and numbers

EU/1/22/1647/001

Date of first authorisation: 24 May 2022

Drugs

Drug	Countries
CAMCEVI	Estonia, Croatia, Lithuania, Romania, United States

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