Day & Night

Main information

  • Trade name:
  • Day & Night Cold & Flu + Cough Capsule, combination
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Day & Night Cold & Flu + Cough Capsule, combination
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222390
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222390

Day & Night Cold & Flu + Cough Capsule, combination

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Johnson & Johnson Pacific Pty Ltd

Postal Address

Locked Bag 5,

BROADWAY, NSW, 2007

Australia

ARTG Start Date

11/04/2014

Product category

Medicine

Status

Active

Approval area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

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, other than condition No. 8 and condition No. 9.

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, other than condition No.11

The therapeutic goods grouped in this registration/listing as export only goods under the following names are included in the Australian Register of

Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. Day & Night Cold & Flu + Cough Capsule, combination

Product Type

Composite Pack

Effective date

11/04/2014

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Temporary relief of cold and flu symptoms, including headaches, body aches and pains, blocked nose, runny nose and dry irritated coughs. Reduces

fever.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Not recorded

Not recorded

36 Months

Store below 30

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

18 day capsules: 6 night capsules

(S1) This Schedule is intentionally blank

Components

1. Day Capsule

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Size "0" hard gelatin capsule, blue-green coloured cap and body, printed

"Day" in black, containing a white to off-white powder.

Active Ingredients

dextromethorphan hydrobromide monohydrate

10 mg

Paracetamol

500 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:26:56 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

Phenylephrine hydrochloride

5 mg

2. Night Capsule

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

White powder in size "0" hard gelatin capsule with white opaque body and

swedish orange opaque cap printed "Night" in black.

Active Ingredients

chlorphenamine maleate

2 mg

dextromethorphan hydrobromide monohydrate

10 mg

Paracetamol

500 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 2 of

Produced at 26.11.2017 at 11:26:56 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

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety