Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
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”. |
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 mgCore: Polyethylene oxide 200K Overcoat: Hypromellose Printing ink: Iron oxide (black) (E172) 6 mgCore: Polyethylene oxide 200K Overcoat: Hypromellose Printing ink: Iron oxide (black) (E172) 9 mgCore: Polyethylene oxide 200K Overcoat: Hypromellose Printing ink: Iron oxide (black) (E172) 12 mgCore: Polyethylene oxide 200K Overcoat: Hypromellose Printing ink: Iron oxide (black) (E172) |
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.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
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
| 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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
