RELPAX MIGRAINE eletriptan hydrobromide 40 mg tablet blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
eletriptan hydrobromide
Available from:
Upjohn Australia Pty Ltd
Authorization status:
Registered
Authorization number:
347050

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Public Summary

Summary for ARTG Entry:

347050

RELPAX MIGRAINE eletriptan hydrobromide 40 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Upjohn Australia Pty Ltd

Postal Address

GPO Box 7015, Sydney, NSW, 2001

Australia

ARTG Start Date

16/12/2020

Product Category

Medicine

Status

Active

Approval Area

Drug Safety Evaluation Branch

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

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

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.

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:

Products

1 . RELPAX MIGRAINE eletriptan hydrobromide 40 mg tablet blister pack

Product Type

Single Medicine Product

Effective Date

16/12/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Acute treatment of migraine headache with or without aura.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Public Summary

Page 1 of

Produced at 11.01.2021 at 11:36:36 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

Pack Size

Poison Schedule

2 tablets

(S4) Prescription Only Medicine

Components

1 . RELPAX MIGRAINE electriptan hydrobromide 40 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Orange, round, convex, film-coated tablet, engraved with "Pfizer" on one side and "REP40" on the other.

Active Ingredients

eletriptan hydrobromide

48.485 mg

Equivalent: eletriptan

40 mg

Other Ingredients (Excipients)

croscarmellose sodium

hypromellose

lactose monohydrate

magnesium stearate

microcrystalline cellulose

sunset yellow FCF

titanium dioxide

triacetin

© 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 11.01.2021 at 11:36:36 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

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