Blue summit ultra plus spray

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

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Active ingredient:
Olea europaea,Propolis resin
Available from:
Careline Australia Pty Ltd
Authorization status:
Listed
Authorization number:
349442

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Public Summary

Summary for ARTG Entry:

349442

Blue summit ultra plus spray

ARTG entry for

Medicine Listed

Sponsor

Careline Australia Pty Ltd

Postal Address

41-43 Bellona Avenue, REGENTS PARK, NSW, 2143

Australia

ARTG Start Date

24/11/2020

Product Category

Medicine

Status

Active

Approval Area

Listed Medicines

Conditions

Colouring agents used in listed medicine for ingestion, other than those listed for export only under section 25 of the Act, shall be only those included in the list

of 'Colourings permitted in medicines for oral use'.

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b)

Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted

to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the

Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside

Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager

Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1 . Blue summit ultra plus spray

Product Type

Single Medicine Product

Effective Date

24/11/2020

Permitted Indications

Decrease/reduce/relieve the severity of symptoms of mild upper respiratory tract infections

Linked indication - Relieve symptoms of mild upper respiratory tract infections

Expectorant/clear respiratory tract mucous

Relieve symptoms of mild upper respiratory tract infections

Maintain/support healthy mucous membranes/mucous tissue of the respiratory tract

Decrease/reduce/relieve symptoms of mild throat infection

Relieve symptoms of sore throat/pharyngitis

Indication Requirements

Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.

Label statement: If symptoms persist, talk to your health professional.

Product presentation must not imply or refer to serious infections.

Respiratory tract infections must be qualified by 'mild'.

Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice (or words to that effect).

Standard Indications

No Standard Indications included on Record

Specific Indications

No Specific Indications included on Record

Warnings

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

WARNING: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.

Not suitable for infants under the age of twelve months (or words to that effect).

Additional Product information

Container information

Public Summary

Page 1 of

Produced at 11.01.2021 at 10:11:16 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

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 . Formulation 1

Dosage Form

Spray

Route of Administration

Oral

Visual Identification

Active Ingredients

Olea europaea leaf Extract liquid concentrate

5 mg/mL

Equivalent: Olea europaea (Dry)

50 mg/mL

Propolis resin

28.6 mg/mL

Equivalent: Propolis

200 mg/mL

Equivalent: lead

285.7 ng/mL

Other Ingredients (Excipients)

glycerol

Honey

Peppermint Oil

purified water

Siraitia grosvenorii

sorbitol solution (70 per cent) (non-crystallising)

© 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 10:11:16 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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