Melatonin

Melatonin

Melatonin
Video

ORODISPERSIBLE FILMS – ODF

Orodispersible films (ODF), is a new oral pharmaceutical form, whose characteristics can improve the treatment compliance of certain groups of subjects whose needs are not met by capsules and tablets.

Benefits/USP
  • Difficulty in falling asleep
  • Elderly
  • Jet lag
COMPOSITION
  • 1 mg Melatonin
  • 1,7 mg of pyridoxine hydrochloride corresponding to 1,4 mg Vitamin B6 (100% VNR)
  • 5,0 mg of Lavander dry extract
  • 5,0 mg of Chamomile dry extract
BENEFITS AND HEALTH CLAIMS
  • Melatonin contributes to the reduction of the time required to fall asleep (Regulation 432/2012)
  • Vitamin B6 contributes to the reduction of tiredness and fatigue; contributes to normal psychological function; contributes to the normal functioning of the nervous system (Regulation 432/2012)
  • Chamomile (Matricaria Chamomilla L.): Relaxation (sleep) and mental wellness
  • Lavender (Lavandula angustifolia Mill): Relaxation (sleep; in case of stress). Normal mood.
Description
  • Film size: 3 x 2 cm. Medium weight 130 mg.
  • Film color: violet
  • Soft fruit natural flavour
Use

1 film/die (30 min before sleeping).

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    Information notice pursuant to art.13 of Regulation EU 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation, so-called “GDPR”)


    Information notice – Business Development

    In accordance with the current personal data protection regulations, IBSA Farmaceutici Italia Srl (hereinafter, the "IBSA” or “Company") as "Data Controller", is required to provide certain information regarding the use of your personal data.


    1. Purpose of the personal data processing
    The processing of your personal data is necessary for the following purposes:
    a) Management of your request prior to entering into a contract further to the information provided by you.
    b) “Marketing communication”: information relating to IBSA products and services and related activities (training, seminaries, etc.), institutional communication on IBSA activities (congresses, launch of new products, marketing communication) through dedicated IBSA personnel and/or forwarding of promotional material through printed or digital channels (i.e. email).


    2. Nature of the provision of the personal data and consent
    We inform you that the processing of your personal data for the purpose referred to in point 1a of this information is carried out in accordance with art. 6.1 lett. b) of the EU Regulation 2016/679, so the provision of data is optional but necessary for the performance of the relationship between the parties. Any refusal will make it impossible for the Data Controller to execute the purpose above.
    We inform you that the processing of your personal data for the purpose referred to in point 1b of this information is carried out pursuant to art. 6.1 lett. a) of the EU Regulation 2016/679, so the consent is optional but essential for the achievement of the purpose itself. Any refusal to provide consent will not allow the achievement of the purpose itself.


    3. How the data are processed
    The data are processed through computer procedures or by automated means or paper by persons, internal or external, specifically assigned to this task and required to confidentiality with logic closely related to the purposes for which the data were collected in any case suitable to ensure the security and confidentiality of the data are protected by security measures provided by law, to prevent unauthorized access, loss or destruction.


    4. How long the data are kept
    The data will be kept for the time strictly necessary for the accomplishment of the purposes set out in this notice and in any event up to the statutory and legal time limit in compliance with the rights and the resulting obligations.


    5. Scope of circulation of the data
    The data may be used by personnel of the Company and of its parent company IBSA Institut Biochimique SA, that have been given appropriate operating instructions under an obligation of confidentiality. The data may also be used by third-party providing operational and additional services on behalf of the Company, which act as external data processors under the direction and supervision of the Company.
    The list of the Data Processors is available by sending a request to privacy@ibsa.ch.


    6. Communication of the data
    In accordance with the laws and regulations that we are subject to, we may be required to communicate the data to the competent Authorities and healthcare associations in third countries outside the EU and to legitimate recipients in accordance with the law and the regulations. These parties will act as independent Data Controllers.


    7. Transfer of the data abroad
    The aforementioned personal data are transferred to Institut Biochimique SA (IBSA SA) in Switzerland, solely for the purposes set out in paragraph 1. In accordance with the laws and regulations to which we are subject to, your personal data may also be communicated and/or transferred to organizations located in other countries, both in EU countries and outside the EU, including countries that may not provide the same level of protection as provided by the applicable legislation, we inform you that the transfer of data abroad is subject to specific guarantees for the protection of personal data through the adoption of standard contractual clauses.


    8. Rights of the data subject
    In relation to the processing of your personal data, you have the right to be informed at any time about your data held by the Company and how they are used. You also have the right to have the data updated, corrected or erased, to request their portability or restriction of processing, in the cases provided for by law, and to object to the processing of the data unless the Company has a legitimate interest in the data. To exercise your rights and to obtain more detailed information about the persons or categories of persons to whom the data are communicated and/or transferred or who become aware of the data as controllers or processors, you can contact us:
    - by e-mail, at: privacy@ibsa.ch ;
    - by post, at: IBSA Farmaceutici Italia Srl, Ufficio Privacy, via della Filanda 30 – 26900 Lodi – Italy;
    Lastly, we remind you that you have the right to lodge a complaint with the Personal Data Protection Authority if you consider that your rights have not been respected or that you have not received a response to your requests in accordance with the law.


    9. Data Controller
    The Data Controller is IBSA Farmaceutici Italia Srl with registered office in Via Martiri di Cefalonia, 2 – 26900 Lodi, Italy.


    10. Data Protection Officer
    The Company has appointed a Data Protection Officer or DPO. The DPO can be contacted via the following communication channel: dpo@ibsa.it



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