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JFDA has suspended the registration of Raptiva (efalizumab
Jordan Food and Drug Administration has suspended the registration of Raptiva because according to EMEA's warnings the benefits of Raptiva no longer outweigh its risks, due to safety concerns, including the occurrence of Progressive Multifocal Leukoencephalopathy (PML) in patients taking the medicine.
In addition to PML, Raptiva is associated with other serious side effects, including Guillain – Barré and Miller-Fisher syndromes, Encephalitis, Encephalopathy, Meningitis, Sepsis and Opportunistic Infections (infections occurring in people with compromised immune systems).
Raptiva has been registered in Jordan under the no.141/2006 (knowing that it was not marketed locally). It is used to treat adult patients with moderate to severe chronic plaque psoriasis (a disease causing red, scaly patches on the skin), who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including Ciclosporin, Methotrexate and PUVA (Psoralen Ultraviolet A).
JFDA advice to patients who are currently taking Raptiva:
1. Not to stop treatment abruptly.
2. Should make an appointment with their doctor to discuss the most appropriate replacement treatment.
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Cancellation of Acomplia(rimonabant) Registration in Jordan
On 26 February 2009 Jordan Food and Drug Adminstration (according to Drug and Pharmacy Law/article 17 B) issued a decision of cancellation the registration of Acomplia (rimonabant), because till now the risks out weigh its benefits, knowing that JFDA has suspended earlier the usage of
Acomplia tablets (Rimonabant) which is used for the treatment of obesity and overweight patients with risk factors.
Acomplia is a prescription only medicine that has been authorized in EUsince 2006.
The Emea's Committee for Medicinal Products for Human Use has concluded, based on evaluation of new data from post-marketing experience regarding psychiatric effects, that the benefits of Acomplia no longer out weigh its risks
Acomplia was registered last April, but was not marketed in Jordan
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Availability of BCG Vaccine
According to JFDA’s request, the Arabic drugstore has thankfully imported sufficient quantity of BCG Vaccine to the local market, due to its high necessity to Tuberculosis patients.
All hospitals and pharmacies are kindly requested to take their needed quantities of the mentioned above vaccine from the Arabic drugstore.
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Issue the import and export authorizations using approved new forms
Narcotic and psychotropic substances control division has started to issue the import and export authorizations using approved new forms
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Jordan integrated hazardous substances information management and control system
This project started in 2003 its current and second phase is intended to be completed by the end of 2006
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Periodic News Letter , Volume (3), 1/2007
Periodic newsletter published by jordan food and drug administration.
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Rational Drug Use unit website is now available
Rational Drug Use unit website is now available, it aims to promote rational prescribing, dispensing and use of drugs by health professionals using evidence-based approach and to encourage the community for appropriate use of drugs.
To enter to the website please
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The following guidelines were published in the official newspaper in the edition no. 4870 dated December 2nd, 2007
To whom it may concern,,,
The following guidelines were published in the official newspaper in the edition no. 4870 dated December 2nd, 2007:
Guidelines of releasing of medicinal plants
preparations and natural products.
Guidelines of registration of medicinal plants.
Guidelines and regulations of releasing the circulation of cosmetics and cosmoceutical preparations.
The above guidelines are available on the website of JFDA.
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Food Law Proposal
Food Law Proposal is available for comments and suggestions) (In the case of any discrepancies between the Arabic and the English versions, the Arabic version should prevail)
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To whom it may concern
The
following guidelines were published in the official newspaper, edition no.4892 on March 16th, 2008:
- Releasing of Special Foods guidelines for the year 2008
- Artificial Sweeteners and Alcoholic Sweeteners guidelines for the year 2008
- Organization of Drug Promotion guidelines for the year 2008
- Medical Samples Specifications and their distribution conditions guidelines for the year 2008
- Accreditation of Manufacturing Sites Guidelines, re-evaluation and cancellation of them for the year 2008
The above guidelines are available on the JFDA website (the Arabic version)
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The new guidelines were recently published in the official newspapers and on the website of JFDA:
The new guidelines were recently published in the official newspapers and on the website of JFDA:
-Guidelines of registration and distribution of pharmaceuticals used in nuclear medicine for the year 2008
(Gazette no. 2160)
-Guidelines of importing and distribution of radioactive materials used in nuclear medicine for the year 2008
(Gazette no. 2163)
-Guidelines of releasing pharmaceuticals containing vitamins and / or minerals for the year 2008
(Gazette no. 2165)
-Guidelines of controlling importing, exporting and distributing chemicals that produce narcotics or psycho tropics for the year 2008
(Gazette no. 2173)
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Availability of Isosorbide Dinitrate 5mg (Cardipine) Tab.
According to JFDA’s request, and due to its high necessity to patients using this treatment, al Hikma Pharmaceuticals Company has thankfully made( Cardipine) Isosorbide dinitrate 5mg tablet available in the market,.
All concerned pharmacies are kindly requested to take their needed quantities of the drug from the mentioned above company.
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Rational Use Of Drug
Pharmaceutical Policy Studies , Plan for RUD Unit , Workshop
helded in amman 21-22 Septemper, 2004
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Role of the Pharmacist
It has been proven that when pharmacists perform a number of specific roles and activities, health outcomes are improved and health care costs reduced. Pharmacy in Jordan is well positioned to take on a number of these roles due to a largely enthusiastic, intelligent, knowledgeable, accessible workforce which has the interests of their patients as a driving force. A Study was designed to “improve the quality of pharmaceutical services and pharmacy practice in Jordan to strengthen drug management systems and rational use of drugs”.
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