Adverse Events Reporting

How to report adverse events

If you are in Italy

Any adverse drug reaction occurred during therapy must be immediately reported to understand if there is a risk for other patients. If you wish to report adverse drug reactions to one of Molteni products, please visit

If you are abroad

Each country has its own rules to regulate the reporting of adverse drug reactions.
If you have an adverse reaction to one of our drugs, we recommend that you contact the local health staff who is following you, or read further this page, to follow the correct reporting procedure.

If you need to contact Molteni pharmacovigilance

In case of questions or inquiries to Molteni pharmacovigilance, you are kindly requested to fill out the following form. We will answer as soon as possible.

* (mandatory field)

We hereby inform you that, pursuant to Art. 13, Legislative Decree no. 196/2003 “Codice in materia di protezione dei dati personali” (Personal Data Protection Code) the processing of your personal/sensitive data will be fulfilled according to principles of fairness, lawfulness and transparency, fully respecting the right to privacy.

  1. The processing of your personal data (name, address, phone number, e-mail) as well as sensitive data (revealing your health status) provided by telephone, e-mail or fax, will have the following purposes: a. purposes strictly related to the management of:

    - spontaneous reports of suspected drug adverse events and relevant request for further investigation by the Medical Directorate/Pharmacovigilance staff in accordance with the current Italian Pharmacovigilance regulations, sent to L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.A..
    - queries or requests for further investigation and information related to MOLTENI drugs, sent to L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.A..

  2. Data processing in relation to the above-mentioned purposes may take place in written, computerized and electronic form, guaranteeing that the data collected shall be absolutely confidential, relevant and non-excessive in relation to the purposes for which they are collected, in terms of recording and data storage periods.
  3. Data processing shall be carried out in compliance with security measures capable of safeguarding the confidentiality, integrity and completeness of the processed data, as defined in Art. 31, Legislative Decree n. 196/2003 and in accordance with the instructions given by the Data Controller; in particular, in relation to the adoption of minimum security measures specified in Articles 33-36 as well as in the technical specifications contained in Annex B of Legislative Decree 196/2003.
  4. For the same purposes, the data may be processed by persons appointed by the PHARMACOVIGILANCE DIRECTORATE and MEDICAL DIRECTORATE of L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.A..
  5. Your personal data shall not be disclosed but may be communicated to:

    - Subjects authorized to access personal data in compliance with the law or for purposes related to Pharmacovigilance.

    Clearly, all the above communications are limited only to the data required by the authorized subject to fulfil his task and/or for purposes related to the communication itself.

  6. The Data Controller is L. MOLTENI & C. dei F.lli Alitti Società di Esercizio S.p.A..
    The Data Controller has appointed Data Processors or Persons in Charge of the processing of personal data within each of the Divisions involved in the processing.
  7. To exercise his rights as provided for by Article 7, Legislative Decree no. 196/2003 (reported in full below) the data subject may refer directly to the Data Controller or the Person in Charge of the Medical Directorate/Pharmacovigilance, with a communication addressed to L. MOLTENI & C. Società di Esercizio S.p.A., headquarters at SS. 67 Fraz. Granatieri - Scandicci (FI) in which the request or the problem is specified.

Art. 7 (Right of access to personal data and other rights)

  1. A data subject has the right to obtain confirmation as to whether or not personal data concerning him exist, regardless of their being already recorded, and communication of such data in intelligible form.
  2. A data subject shall have the right to be informed
    1. of the source of the personal data;
    2. of the purposes and methods of the processing;
    3. of the logic applied to the processing, if the latter is carried out with the help of electronic means;
    4. of the identification data concerning data controller, data processors and the representative designated, as per Art. 5, para. 2;
    5. of the entities or categories of entities to whom or which the personal data may be communicated or who or which may get to know said data in their capacity as designated representative(s) in the State’s territory, data processor(s) or person(s) in charge of the processing.
  3. A data subject shall have the following rights:
    1. to obtain updating, rectification or, where interested therein, integration of the data;
    2. to obtain erasure, anonymization or blocking of data that have been processed unlawfully, including data whose retention is unnecessary for the purposes for which they have been collected or subsequently processed;
    3. to obtain certification to the effect that the operations as per letters a) and b) have been notified, as also related to their contents, to the entities to whom or which the data were communicated or disseminated, unless this requirement proves impossible or involves a manifestly disproportionate effort compared with the right that is to be protected.
  4. A data subject shall have the right to object, in whole or in part:
    1. on legitimate grounds, to the processing of personal data concerning him/her, even though they are relevant to the purpose of the collection;
    2. to the processing of personal data concerning him/her, where it is carried out for the purpose of sending advertising materials or direct selling or else for the performance of market or commercial communication surveys.