POMALYST

Main information

  • Trade name:
  • POMALYST pomalidomide 4 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • POMALYST pomalidomide 4 mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212655
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212655

POMALYST pomalidomide 4 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Celgene Pty Ltd

Postal Address

Level 15 / 60 City Road,Southbank, VIC, 3006

Australia

ARTG Start Date

1/07/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. POMALYST pomalidomide 4 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

24/03/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have

received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last

therapy

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

48 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

21 capsules

(S4) Prescription Only Medicine

Components

1. POMALYST pomalidomide 4 mg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

Dark blue/blue size 2 gelatin capsules marked POML 4 mg in white ink

Active Ingredients

pomalidomide

4 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 12:08:43 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

2-8-2018

Orphan designation:  Pomalidomide,  for the: Treatment of multiple myeloma

Orphan designation: Pomalidomide, for the: Treatment of multiple myeloma

Europe - EMA - European Medicines Agency

11-9-2018

Imnovid (Celgene Europe B.V.)

Imnovid (Celgene Europe B.V.)

Imnovid (Active substance: Pomalidomide) - Centralised - Variation - Decision addressed to Member States - Commission Decision (2018)5970 of Tue, 11 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2682/R/28

Europe -DG Health and Food Safety

27-7-2018

EU/3/09/672 (Celgene Europe B.V.)

EU/3/09/672 (Celgene Europe B.V.)

EU/3/09/672 (Active substance: Pomalidomide) - Transfer of orphan designation - Commission Decision (2018)5041 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/053/09/T/01

Europe -DG Health and Food Safety

13-7-2018

Imnovid (Celgene Europe Limited)

Imnovid (Celgene Europe Limited)

Imnovid (Active substance: Pomalidomide) - Centralised - Renewal - Commission Decision (2018)4713 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2682/R/28

Europe -DG Health and Food Safety