INVEGA Prolonged-release tablet Ref.[7471] Active ingredients: Paliperidone

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

INVEGA 3 mg prolonged-release tablets.

INVEGA 6 mg prolonged-release tablets.

INVEGA 9 mg prolonged-release tablets.

INVEGA 12 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with “PAL 3”.

Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter printed with “PAL 6”.

Trilayer capsule-shaped pink tablets of 11 mm in length and 5 mm in diameter printed with “PAL 9”.

Trilayer capsule-shaped yellow tablets of 11 mm in length and 5 mm in diameter printed with “PAL 12”.

Qualitative and quantitative composition

Each prolonged-release tablet contains 3 mg of paliperidone.

Each prolonged-release tablet contains 6 mg of paliperidone.

Each prolonged-release tablet contains 9 mg of paliperidone.

Each prolonged-release tablet contains 12 mg of paliperidone.

Excipient with known effect: Each 3 mg tablet contains 13.2 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Paliperidone

Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics. Even though paliperidone is a strong D2-antagonist, which is believed to relieve the positive symptoms of schizophrenia, it causes less catalepsy and decreases motor functions to a lesser extent than traditional neuroleptics.

List of Excipients

3 mg

Core:

Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butyl hydroxytoluene (E321)
Ferric oxide (yellow) (E172)
Polyethylene oxide 7000K
Ferric oxide (red) (E172)
Hydroxyethyl cellulose
Polyethylene glycol 3350
Cellulose acetate

Overcoat:

Hypromellose
Titanium dioxide (E171)
Lactose monohydrate
Triacetin
Carnauba wax

Printing ink:

Iron oxide (black) (E172)
Propylene glycol
Hypromellose

6 mg

Core:

Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butyl hydroxytoluene (E321)
Polyethylene oxide 7000K
Ferric oxide (red) (E172)
Hydroxyethyl cellulose
Polyethylene glycol 3350
Cellulose acetate

Overcoat:

Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400
Ferric oxide (yellow) (E172)
Ferric oxide (red) (E172)
Carnauba wax

Printing ink:

Iron oxide (black) (E172)
Propylene glycol
Hypromellose

9 mg

Core:

Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butyl hydroxytoluene (E321)
Polyethylene oxide 7000K
Ferric oxide (red) (E172)
Iron oxide (black) (E172)
Hydroxyethyl cellulose
Polyethylene glycol 3350
Cellulose acetate

Overcoat:

Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400
Ferric oxide (red) (E172)
Carnauba wax

Printing ink:

Iron oxide (black) (E172)
Propylene glycol
Hypromellose

12 mg

Core:

Polyethylene oxide 200K
Sodium chloride
Povidone (K29-32)
Stearic acid
Butyl hydroxytoluene (E321)
Polyethylene oxide 7000K
Ferric oxide (red) (E172)
Ferric oxide (yellow) (E172)
Hydroxyethyl cellulose
Polyethylene glycol 3350
Cellulose acetate

Overcoat:

Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400
Ferric oxide (yellow) (E172)
Carnauba wax

Printing ink:

Iron oxide (black) (E172)
Propylene glycol
Hypromellose

Pack sizes and marketing

Bottles: White high-density polyethylene (HDPE) bottle with induction sealing and polypropylene child-resistant closure. Each bottle contains two 1 g dessicant silica gel (silicone dioxide) pouches (pouch is food approved polyethylene).

Pack sizes of 30 and 350 prolonged-release tablets.

Blisters:

Polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.

Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.

Or

White polyvinyl chloride (PVC) laminated with polychloro-trifluoroethylene (PCTFE)/aluminium push-through layer.

Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.

Or

Oriented polyamide (OPA)-aluminium-polyvinyl chloride (PVC)/aluminium push-through child-resistant blister.

Pack sizes of 14, 28, 49, 56, and 98 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

3 mg:

EU/1/07/395/001-005
EU/1/07/395/021-025
EU/1/07/395/041-044
EU/1/07/395/057-058
EU/1/07/395/065-067

6 mg:

EU/1/07/395/006-010
EU/1/07/395/026-030
EU/1/07/395/045-048
EU/1/07/395/059-060
EU/1/07/395/068-070

9 mg:

EU/1/07/395/011-015
EU/1/07/395/031-035
EU/1/07/395/049-052
EU/1/07/395/061-062
EU/1/07/395/071-073

12 mg:

EU/1/07/395/016-020
EU/1/07/395/036-040
EU/1/07/395/053-056
EU/1/07/395/063-064
EU/1/07/395/074-076

Date of first authorisation: 25 June 2007
Date of latest renewal: 14 May 2012

Drugs

Drug Countries
INVEGA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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