DIPYRIDAMOLE Film-coated tablet Ref.[7996] Active ingredients: Dipyridamole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

DIPYRIDAMOLE TABLETS BP 25mg.

Pharmaceutical Form

Orange film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 25mg Dipyridamole BP.

Active Ingredient Description
Dipyridamole

Dipyridamole is an antithrombotic agent with antiplatelet activity. Dipyridamole has an antithrombotic action based on its ability to modify various aspects of platelet function, such as platelet aggregation, adhesion and survival, which are factors associated with the initiation of thrombus formation.

List of Excipients

Also contains: lactose, magnesium stearate, maize starch, polyvidone, propylene glycol, E104, E110, E132, E171, E464, E553.

Pack sizes and marketing

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250ยตm white rigid PVC. (ii) Surface printed 20ยตm hard temper aluminium foil with 5-6g/M2 PVC and PVdC compatible heat seal lacquer on the reverse side.

The product may be contained in blister packs which enhances security of the pack increasing resistance to deliberate contamination, pilfering, etc.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/0308

24.8.90

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