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ROVI obtains FDA approval of its injectables plant

Tue, 18/09/2012 - 16:45 0 min

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OFFICE MADRID

Calle José Isbert, 2.
28223 Pozuelo de Alarcón (Madrid) - España
Tel: (+34) 91 021 30 00 email: rovi@rovi.es

OFFICE BARCELONA

Travesera de Gracia, 415-417.
08025 Barcelona - España

OFFICE FRANCIA

Rue du Drac, 24.
38180 Seyssins. France

OFFICE ALEMANIA

Rudolf-Diesel-Ring, 6.
83607 Holzkirchen. Germany

OFFICE ITALIA

Viale Achille Papa, 30.
20149 Milano. Italy

OFFICE UNITED KINGDOM

Davis House, 4th floor, Suite
425, Robert Street CR0 1QQ
Croydon. England

OFFICE PORTUGAL

Alameda Fernão Lopes 16, 12º direito
1495-190 Algés
Portugal
Tel: (00351) 21 310 56 10
email: geral@rovi.com

Map

PRIVACY POLICY
TERMS AND CONDITIONS
LEGAL NOTICE
COOKIE POLICY
EXERCISE OF RIGHTS GDPR

Copyright © 2017 Laboratorios Farmaceuticos ROVI SA - All rights reserved

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PRIVACY POLICY

In accordance with the provisions of the General Data Protection Regulation, any personal data that may be provided by the User through this Website will be processed by Laboratorios Farmacéuticos Rovi, S.A. (hereinafter, "Rovi") in order to respond to the User's request, application or query.

The contact information for ROVI is as follows:

Identity: Laboratorios Farmacéuticos ROVI, S.A. (Rovi) – Tax ID No.: A-28041283.
Postal address: Julián Camarillo, 35, 28037 Madrid.
Telephone: 91 375 62 30.
Email Address: protecciondedatos@rovi.es
DPO Contact: dporovi@rovi.es

The data will be processed on the legal basis of consent having been granted by the individual providing said data. The User may withdraw said consent at any time, although this shall not affect the lawfulness of the processing operations that had been carried out prior to said withdrawal. Provision of data is voluntary; however, if data is not provided, the queries made cannot be responded to. The data will be kept for the amount of time necessary to respond to the User's request and, subsequently, as long as any type of legal responsibility may last as a result thereof. In the event that data belonging to third parties is provided, it is the responsibility of the User making the data provision to inform said third parties on all of the provisions herein and, especially, on the provisions of Article 14 of the General Data Protection Regulation. The User must also have obtained prior consent from said third parties to make such a data provision.

The User is responsible for the information provided through this Website being true. Thus, the User is to be held liable for the veracity of all data provided and is responsible for conveniently keeping said data up to date so that it reflects reality. The User will be held liable for any false information or inaccurate statements provided and for any losses and/or damages this causes to ROVI or to third parties.

ROVI guarantees the security and confidentiality of the personal data provided. To this end, all measures of a technical and organisational nature that are appropriate have been implemented so as to avoid the alteration, loss, and/or unauthorised processing of –and access to– the User's data, as stipulated in the General Data Protection Regulation.

Users are hereby informed of the possibility to exercise their rights to access, rectify, delete, limit processing, oppose, and request data portability through a written, signed request that contains the following information: name, surname(s), address for the purposes of notification, photocopy of identity card or passport, and specific mention of the right to be exercised. Such a request must be sent to any of the aforementioned contact addresses for ROVI (normal post or email). Should any possible violation of your rights arise, you may file a complaint with the Spanish Data Protection Agency.

The ROVI Group is active in a number of countries, including both other Group companies, customers and suppliers. Some of these third parties may be located in other countries, so that personal data may be transferred outside the countries where we and our customers are located.

This includes countries outside the European Union, and also countries that do not have laws providing specific protection for personal data. ROVI has taken steps to ensure that all personal data is adequately protected and that all transfers of personal data outside the EU are carried out in accordance with European Union standards of legality and security. If personal data is transferred outside the EU to a country that the European Commission does not determine provides an adequate level of protection for personal data, transfers will be made under an agreement that covers the EU requirements for the transfer of personal data outside the EU, such as the standard contractual clauses approved by the European Commission.

All ROVI Group Companies are located within the European Union, except ROVI Biotech Limited UK. The United Kingdom has an adequacy decision approved by the European Commission and is therefore considered to have an adequate level of protection

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TERMS AND CONDITIONS

1.- These Terms and Conditions of Use set the rules to which the use of this Website's Contents are subject (hereinafter, the "Contents"). By accessing, downloading or using the Contents, you are considered a User, and said actions imply acceptance of all the terms and conditions contained in this document, in the Website's Privacy Policy and Legal Notice. The User must read these conditions each time he/she accesses, downloads or uses the Contents, as they may be modified in the future.

2.- Certain sections of the Rovi websites have been designed for specific audiences including the general public, healthcare professionals, shareholders of ROVI, etc.
When the Website is directed to healthcare professionals, a specific mention will be made.
Within the various services included in the Rovi websites, is to provide information on ROVI activities, products, health information and the health field. While some medical information may appear in the ROVI websites, if you are in a medical process, please refer to your doctor or to your healthcare provider. We do not offer personalized medical diagnosis or specific medical advice for patients.

3.- The Contents, as well as trademarks and other distinctive marks that appear therein, are the property of their respective holders or of Laboratorios Farmacéuticos Rovi, S.A. (hereinafter, "Rovi"). Users can access the Contents for consultation or for downloading in accordance with the conditions set out in this document. To this end, a content use license, non – exclusive and royalty free, is recognize to the user for medical and educational purposes. Such content use license is granted with the same terms and conditions for Contents updated and improvements. This license may be revoked unilaterally at any time, by merely notifying the User on this Web page.

It is prohibited to elude, disable or otherwise manipulate (or to attempt to elude, deactivate, or manipulate) the Website's security (or other) features, and to use the Contents for commercial or advertising purposes. Likewise, it is prohibited to use the Contents with the purpose of harming the assets, rights, or interests of Rovi, the authors or third parties.

4.- The User must refrain from: a) transforming or modifying the Contents; b) deleting or altering the author's name in the Contents; c) extracting or reusing all or a substantial part of the Contents in other works – unless express permission is granted by the author.

5.- The User commits to properly using the Contents in accordance with the law, these Terms and Conditions of Use, and any other regulations and/or instructions which may be of application. The User shall be held liable to Rovi, to the author, and to third parties for any losses or damages that may be caused by a failure to comply with these obligations.

6.- These Terms of Use are governed entirely by Spanish law. For the resolution of any disputes relating to their interpretation or application, the User expressly agrees to turn to the jurisdiction of the courts of Madrid (Spain).

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LEGAL NOTICE

This webpage is owned by the company Laboratorios Farmaceúticos Rovi, S.L. (referred to hereinafter as Rovi), with registered address in C/ Julián Camarillo, 35, 28037, Madrid, with CIF number A-28041283 and recorded in the Companies Registry of Madrid, Volume 3823, Page 1, Section 8, Sheet M-64245. Contact telephone number 91-3756230, fax 91-3047881 and the e-mail address for these matters is departamentolegal@rovi.es. Rovi is a Pharmaceutical Laboratory authorized under Nº 2808E by the Spanish Agency for Medication and Health Products.

The use of this WebPage attributes the condition of User to the visitor and implies the total acceptance of the conditions included in this Legal Notice. The User must read these conditions every time when accessing this Web, as these can be modified in the future. Certain aspects of the Web, due to its specialty, may be subject to particular conditions or rules that could replace or modify this Leal Notice, and therefore should also be accepted by the User making use or accessing them.

In any case, it is prohibited to alter or modify any part of the Website or its contents, elude, disable or manipulate in anyway (or trying to elude, disable or manipulate) the Web´s security features or other functions of the program and the use of the Web or its content for commercial or advertising purposes.You may not use this WebSite in a way that could damage the property, rights or interest of Rovi or third parties.

It is also prohibited to make any use of this Web that could alter, damage or affect networks, servers, equipments, products and software of Rovi or third parties. All the contents of this Web (texts, photographs, graphics, images, technology, software, links, audiovisual contents or audios, graphic design, source code, etc.), as well as other trademarks and distinctive signs owned by Rovi or third parties, not transferring to the User any right over them by the mere use of this Web.The User must abstain from: a) reproduce, copy, distribute, make available to third parties, public communication, transform or modify the contents of this Web, except in the cases referred in the law or expressly authorized by Rovi or by the holder of such rights ; b) reproduce or copy for private use the software, images, videos or existing databases of this Web, as well as publishing or making available to third parties when this involves reproduction; c) remove or reuse the contents included in this Web.

Users wishing to introduce links to this Web from their own WebPages, will be required to comply with the following conditions:

The link will exclusively lead to the home page, not being able to reproduce it in any way; To consult the codes of conduct of Rovi, click here.

No frames of any type can be created to surround the Web o that allow viewing the Web from different WebSites or in conjunction with other Sites or with contents outside our Web, that may lead to errors or Users confusion about the origin of the service or content, or that may involve an act of comparison or unfair imitation, or taking advantage of the reputation and prestige of Rovi´s brand, or made in a way forbidden by Law;

From the webpage of the link no false or inaccurate statement can be made about Rovi or the quality of its products or services;

The sender cannot use the brand or any other distinctive trademark of Rovi inside its WebPage, except in the cases authorized by Law or expressly authorized by Rovi; e) The page setting the link shall take into consideration the current legislation and cannot dispose or link to illicit contents, harmful, contrary to morals and good customs, that could lead to the false idea that Rovi backs or supports these ideas, statements or actions of the sender, or that are inadequate related to the activity developed by Rovi, taking into account the contents and general theme of the WebPage were the link is established.

It is not Rovi´s responsibility controlling that this Web there are no malware or harmful programs that may affect user´s computer. In any case, it is User´s responsibility to have the adequate tools for detection and disinfection of these items. Accordingly, Rovi will not be liable for any damage produced to Users when such damages are originated in failures or disconnections in the telecommunication networks interrupting this web´s service.

This web includes links that allow the User to access other WebPages. In these cases, Rovi will only be responsible of the contents and services provided through the links as long as it has not been evidenced unlawfulness and has not deactivated them diligently. If a User considers that there is a link with unlawful or inappropriate content will be able to inform Rovi, not implying that Rovi is obliged to remove the corresponding link. Rovi is not always aware of the contents and services provided by the links and therefore is not responsible for any harm that may result due to the lack of quality, obsoleteness, unavailability, error, uselessness or illegality and does not respond to the statements made or contents or services provided by them, unless it is directly responsible for the provision of such services.

The User undertakes to make proper use of this Web, according to the Law, to this Legal Notice and the rest of conditions, rules and instructions that, in its case, could be applicable. The User will have to answer for any damage caused due to the non compliance to these obligations to Rovi and third parties.

This Legal Notice is governed entirely by the Spanish legislation. For the resolution of any dispute or interpretation of this Legal Notice, the User expressly submits himself to the Courts of Madrid (Spain).

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COOKIE POLICY

What is a "cookie"?

A cookie is a file that is downloaded onto your computer when you access certain webpages. Cookies allow a website, among other things, to store and retrieve information about the browsing habits of a user or a user's machine and –depending on the information they contain and the way in which your computer is used– they may be used to recognise your machine.

However, these methods only obtain information related to the number of pages visited, the city to which the IP address used for access is assigned, the number of new users, the frequency, recurrence of visits, the time of each visit, the browser, operator and terminal type from which the visit was made. Data on the User's first name, surname, mailing address, or other similar data about the User is never obtained.

What types of cookies exist?

Cookies can be first-party or third-party cookies. First-party cookies are those that are sent to the User's machine from a computer or domain managed by the Website's editor to provide the service requested by the User. Third-party cookies are those that are sent to the User's machine from a computer or domain not managed by the Website's editor but instead by another entity which processes the data obtained through said cookies.

In addition, cookies may be session cookies or persistent cookies. Session cookies are a type of cookies designed to collect and store data while the User accesses a website. Persistent cookies are a type of cookie that keeps data stored on the terminal and can be accessed and processed for an amount of time defined by the person in charge of said cookie – said amount of time may vary between a few minutes and several years.

Who is responsible for the management of cookies on this Website?

The owner of the Website and the data controller for the cookies used on the Site, as well as their contact information, are accessible in the Website's Legal Notice. Likewise, there may be third-party cookies from sources other than the owner of this Website, as explained below.

What cookies are used by this Website and what are they used for?

This Website uses own cookies. These are cookies designed to allow the communication between the user's computer and the network, the establishment of the user's language and the detection of the acceptance of the use of cookies and does not use third-party cookies.

How long are cookies stored for?

Cookie SSESS is stored for 24 days.

Cookie DRUPAL_UID is stored for 24 days.

Cookie has_js stored during the session last.

Cookie lng is stored for 24 hours.

Cookie cookie-agreed is stored for 100 days.

What is the legal basis for using cookies?

In the case of technical cookies, i.e. those that are indispensable for browsing this website and receiving the service offered through it, the legal basis for the use of cookies is the agreement whereby you decide to use this website and use the services offered through it.

To whom will the cookies be communicated and who can access them?

When there are third-party cookies, as stated above, the pertinent third parties may access the cookies and use them as described above.

What rights exist in relation to the use of cookies by this website?

According to current legislation, anyone has the right to obtain confirmation as to whether or not personal data that concern them are being processed. Likewise, under the conditions set out by law, data subjects are entitled to access their data and to request rectification of any inaccurate data or, if applicable, request they be erased when, among other reasons, the data are no longer necessary for the purposes for which they were collected. In the case of cookies, these rights may be exercised subject to the limitations derived from the nature of these files.

Under the conditions set out in the General Data Protection Regulation, data subjects may request the processing of their data be limited or the portability of their data, in which case we will only store them in order to lodge or defend ourselves against complaints.

Under certain circumstances, for reasons concerning their own specific situations, data subjects may object to the processing of their data. If you have given your consent for a specific purpose, you have the right to withdraw it at any time, although this does not mean that any processing based on the consent prior to its withdrawal will be illegal. In these cases, we will stop processing the data or, where applicable, will stop processing them for the aforementioned specific purpose, except for imperative legitimate reasons or to lodge or defend ourselves against possible complaints.

You may lodge a complaint with the Spanish Data Protection Agency (contact details available at www.agpd.es) or other competent supervisory authority against any violation of your rights, especially if you have exercised them without obtaining satisfaction. You may also obtain further information on your rights by contacting said authorities.

How can I manage cookies?

You can allow, block or delete the cookies installed on your computer by configuring the options of your browser. You can find information on how to do this for the most common browsers in the links below:
• Explorer: https://support.microsoft.com/es-es/help/17442/windows-internet-explorer-delete-manage-cookies
• Firefox: https://support.mozilla.org/es/kb/habilitar-y-deshabilitar-cookies-sitios-web-rastrear-preferencias
• Chrome: http://support.google.com/chrome/bin/answer.py?hl=es&answer=95647
• Safari: https://support.apple.com/es-es/guide/safari/sfri11471/mac

Please note, however, that disabling a cookie may prevent or hinder browsing or the provision of the services offered on this Website.

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EXERCISE OF RIGHTS GDPR

A) FORM FOR EXERCISE OF RIGHT OF ACCESS

ROVI GROUP, in compliance with the obligations set out in the personal data protection legislation, acknowledges and guarantees to the persons whose personal data form part of its files, with the legal limitations, the rights of access, rectification, erasure, restriction of processing, portability and objection.

This request should be sent to GRUPO ROVI: C/ Julián Camarillo 35, 28035 Madrid, or to the e-mail address protecciondedatos@rovi.es.

Particulars of applicant:

Mr/Ms ...................................................................................., of legal age, domiciled at ..................(Street name).......................................... ..(Number).., …………..(Municipality)............., ....(Province)...., …(Postcode)…, with national identity document No. ..........................., hereby expresses his/her wish to exercise his/her right of access, in accordance with the provisions of article 15 of the European General Data Protection Regulation.

He/she requests:

1.- That he/she be provided, free of charge, with information on the personal data processed that concern him/her [specify the personal data to which access is requested].
2.- That the information requested should be sent by e-mail to the address stated above.

Signature of applicant:

………...(Place)..............., ...........(Date)............, 20..

B) FORM FOR EXERCISE OF RIGHT TO RECTIFICATION

ROVI GROUP, in compliance with the obligations set out in the personal data protection legislation, acknowledges and guarantees to the persons whose personal data form part of its files, with the legal limitations, the rights of access, rectification, erasure, restriction of processing, portability and objection.

This request should be sent to GRUPO ROVI: C/ Julián Camarillo 35, 28035 Madrid, or to the e-mail address protecciondedatos@rovi.es.

Particulars of applicant:

Mr/Ms ...................................................................................., of legal age, domiciled at ..................(Street name).......................................... ..(Number).., …………..(Municipality)............., ....(Province)...., …(Postcode)…, with national identity document No. ..........................., hereby expresses his/her wish to exercise his/her right to rectification, in accordance with the provisions of article 15 of the European General Data Protection Regulation.

He/she requests:

That the personal data set out below be rectified and replaced by those mentioned for each item:
……………………………………..
……………………………………..
……………………………………..
……………………………………..
Signature of applicant:

………...(Place)..............., ...........(Date)............, 20..

C) FORM FOR EXERCISE OF THE RIGHT TO ERASURE

ROVI GROUP, in compliance with the obligations set out in the personal data protection legislation, acknowledges and guarantees to the persons whose personal data form part of its files, with the legal limitations, the rights of access, rectification, erasure, restriction of processing, portability and objection.

This request should be sent to GRUPO ROVI: C/ Julián Camarillo 35, 28035 Madrid, or to the e-mail address protecciondedatos@rovi.es.

Particulars of applicant:

Mr/Ms ...................................................................................., of legal age, domiciled at ..................(Street name).......................................... ..(Number).., …………..(Municipality)............., ....(Province)...., …(Postcode)…, with national identity document No. ..........................., hereby expresses his/her wish to exercise his/her right to erasure, in accordance with the provisions of article 15 of the European General Data Protection Regulation.

He/she requests:

That the following personal data concerning me be erased:
.................................................................................................................................

Reasons for erasure:

The reasons for which erasure of the data is requested are as follows: ...................................................................................................................................................................................................................................................................................................................................................................................................

Signature of applicant:

………...(Place)..............., ...........(Date)............, 20..

D) FORM FOR EXERCISE OF THE RIGHT TO RESTRICTION OF PROCESSING

ROVI GROUP, in compliance with the obligations set out in the personal data protection legislation, acknowledges and guarantees to the persons whose personal data form part of its files, with the legal limitations, the rights of access, rectification, erasure, restriction of processing, portability and objection.

This request should be sent to GRUPO ROVI: C/ Julián Camarillo 35, 28035 Madrid, or to the e-mail address protecciondedatos@rovi.es.

Particulars of applicant:

Mr/Ms ...................................................................................., of legal age, domiciled at ..................(Street name).......................................... ..(Number).., …………..(Municipality)............., ....(Province)...., …(Postcode)…, with national identity document No. ..........................., hereby expresses his/her wish to exercise his/her right to restriction of processing, in accordance with the provisions of article 15 of the European General Data Protection Regulation.

He/she requests:

That the processing of the following personal data be restricted: .................................................................................................................................
Signature of applicant:

………...(Place)..............., ...........(Date)............, 20..

E) FORM FOR EXERCISE OF THE RIGHT TO DATA PORTABILITY

ROVI GROUP, in compliance with the obligations set out in the personal data protection legislation, acknowledges and guarantees to the persons whose personal data form part of its files, with the legal limitations, the rights of access, rectification, erasure, restriction of processing, portability and objection.

This request should be sent to GRUPO ROVI: C/ Julián Camarillo 35, 28035 Madrid, or to the e-mail address protecciondedatos@rovi.es.

Particulars of applicant:

Mr/Ms ...................................................................................., of legal age, domiciled at ..................(Street name).......................................... ..(Number).., …………..(Municipality)............., ....(Province)...., …(Postcode)…, with national identity document No. ..........................., hereby expresses his/her wish to exercise his/her right to data portability, in accordance with the provisions of article 15 of the European General Data Protection Regulation.

He/she requests:

• That the personal data provided to the data controller be sent to me in a structured, commonly used and machine-readable format.
• That the personal data provided to the data controller be sent to the following company _______________________ in a structured, commonly used and machine-readable format.
[LEAVE THE APPLICABLE OPTION AND DELETE THE OTHER]

Signature of applicant:

………...(Place)..............., ...........(Date)............, 20..

F) FORM FOR EXERCISE OF THE RIGHT TO OBJECT

ROVI GROUP, in compliance with the obligations set out in the personal data protection legislation, acknowledges and guarantees to the persons whose personal data form part of its files, with the legal limitations, the rights of access, rectification, erasure, restriction of processing, portability and objection.

This request should be sent to GRUPO ROVI: C/ Julián Camarillo 35, 28035 Madrid, or to the e-mail address protecciondedatos@rovi.es.

Particulars of applicant:

Mr/Ms ...................................................................................., of legal age, domiciled at ..................(Street name).......................................... ..(Number).., …………..(Municipality)............., ....(Province)...., …(Postcode)…, with national identity document No. ..........................., hereby expresses his/her wish to exercise his/her right to object to processing of the data, in accordance with the provisions of article 15 of the European General Data Protection Regulation.

He/she requests:

That, with the limitations provided for by law, my personal data should no longer be used for the following purposes:.................................................................................................................................
Signature of applicant:

………...(Place)..............., ...........(Date)............, 20..