MEPACT Powder for concentrate for dispersion for infusion Ref.[9701] Active ingredients: Mifamurtide

Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Takeda France SAS, 112 avenue Kléber, 75116, Paris, France

Product name and form

MEPACT 4 mg powder for concentrate for dispersion for infusion.

Pharmaceutical Form
Powder for concentrate for dispersion for infusion. White to off-white homogeneous cake or powder.

Qualitative and quantitative composition

Each vial contains 4 mg mifamurtide*.

After reconstitution, each mL of suspension in the vial contains 0.08 mg mifamurtide.

* fully synthetic analogue of a component of Mycobacterium sp. cell wall.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Mifamurtide	Mifamurtide (MTP-PE) is a fully synthetic derivative of muramyl dipeptide (MDP). MTP-PE is a potent activator of monocytes and macrophages. The exact mechanism by which mifamurtide activation of monocytes and macrophages leads to anti-tumour activity in animals and humans is not yet known.

List of Excipients
1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)

Pack sizes and marketing

50 mL type I glass vial with a grey butyl rubber stopper, aluminium seal and plastic flip-off cap, containing 4 mg of mifamurtide.

Each carton contains 1 vial and 1 single-use, non-pyrogenic, sterile filter for MEPACT supplied in a PVC-grade blister.

Marketing authorization holder

Takeda France SAS, 112 avenue Kléber, 75116, Paris, France

Marketing authorization dates and numbers

EU/1/08/502/001

Date of first authorisation: 6 March 2009
Date of latest renewal: 20 February 2019

Drugs

Drug	Countries
MEPACT	Austria, Brazil, Cyprus, Estonia, Spain, Finland, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom

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