CRED NPM

Preclinical studies in animals showed no significant systemic toxicity with topical application. No evidence of mutagenic or carcinogenic potential was observed. In reproductive studies, high doses of Silentinine affected auditory development in animal models.

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl Alcohol Carbomers Phospholipon 80H (Hydrogenated Soy Lecithin) Polysorbate 80 (Tween 80)

Propylene Glycol Vitamin E Acetate Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years. After first use, 18 weeks

6.4 Special precautions for storage

Store below 25°C

6.5 Nature and contents of container

Aluminium container

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.

MARKETING AUTHORISATION HOLDER

AESGP

Avenue de Tervuren 7

B-1040 Brussels

8.

MARKETING AUTHORISATION NUMBER(S)

EU/1/14/522/007

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23/06/2010 Date of latest renewal: 23/05/2015

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