PIZOGRAN Film-coated tablet Ref.[28048] Active ingredients:

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Pizogran 0.5 mg film-coated tablets.

Pizogran 1.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pizogran 0.5 mg film-coated tablets:

White, round, film-coated tablets with Remedica’s logo on one side.

Pizogran 1.5 mg film-coated tablets:

White, round, film-coated tablets.

Qualitative and quantitative composition

Pizogran 0.5 mg film-coated tablets: Each film-coated tablet contains pizotifen maleate equivalent to 0.5 mg pizotifen.

Pizogran 1.5 mg film-coated tablets: Each film-coated tablet contains pizotifen maleate equivalent to 1.5 mg pizotifen.

Excipient(s) with known effect:

Pizogran 0.5 mg film-coated tablets: This product contains 32.14 mg lactose.

Pizogran 1.5 mg film-coated tablets: This product contains 96.42 mg lactose.

For the full list of excipients, see section 6.1.

List of Excipients

Core:

Lactose monohydrate
Microcrystalline cellulose
Maize starch
Povidone
Colloidal silicon dioxide
Magnesium stearate

Coating:

Hypromellose
Polyethylene glycol 6000
Talc
Titanium dioxide E171

Pack sizes and marketing

Pizogran 0.5 mg film-coated tablets:

PVC-PVDC/Aluminium blisters. Pack-sizes of 30, 60, 100 and 1000 film-coated tablets.

PP containers with PE closure. Pack-sizes of 100 film-coated tablets.

Pizogran 1.5 mg film-coated tablets:

PVC-PVDC/Aluminium blisters. Pack-sizes of 30, 100 and 1000 film-coated tablets.

PP containers with PE closure. Pack-sizes of 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Pizogran 0.5 mg film-coated tablets: 20191
Pizogran 1.5 mg film-coated tablets: 20192

Pizogran 0.5 mg film-coated tablets:

Date of first authorization: 28 February 2007
Date of latest renewal: 16 January 2013

Pizogran 1.5 mg film-coated tablets:

Date of first authorization: 28 February 2007
Date of latest renewal: 29 March 2013

Drugs

Drug Countries
PIZOGRAN Cyprus

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