Regarding therapeutic indications for herbal medicinal products
with a well-established medicinal use, a standard statement "herbal medicinal product
Arimoclomol has also been granted orphan medicinal product
status for the treatment of ALS by the European Commission.
4 * should be used to treat cancer that circumstance specified in the authorization for the medicinal product
The Company controls/owns exclusive worldwide ownership/rights for a total of 134 proprietary natural herbal medicinal products
/formulas as Two Natural Herbal Medicinal Product
lines: King of Herbs products and Taoist Medicinal products
The contractor is obliged to deliver the medicinal product
from the label, the label in the language of Polish (if applicable).
3) was revised in order to include a reference to the "Guideline on excipients in the label and package leaflet of medicinal products
for human use" and to the need to put an appropriate warning on the label in case a herbal medicinal product
LOS ANGELES -- CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced that its lead drug candidate arimoclomol has been granted orphan medicinal product
status for the treatment of amyotrophic lateral sclerosis (ALS) by the European Commission.
This Directive will amend the existing European Directive 2001/83/EC which provides the basic requirements for marketing authorization of a medicinal product
including the proof of quality, safety and efficacy.
In addition to the general provisions on labelling and content of package leaflets, a specific statement will be included that the product is a traditional herbal medicinal product
and that its efficacy has not been clinically proven but relies on tradition.
Nektar Therapeutics (Nasdaq:NKTR) announced today that its Amphotericin B Inhalation Powder (ABIP) product has been granted orphan medicinal product
designation by the European Commission for the prevention of pulmonary fungal infections in patients deemed at risk.
XOMA Ltd (Nasdaq:XOMA) announced today that the European Commission has granted an orphan medicinal product
designation to XOMA's drug NEUPREX(R) (opebacan) in meningococcal disease, a potentially life-threatening bacterial infection predominantly affecting young children.
On July 14, 2006, the EMEA's Committee for Orphan Medicinal Products
(COMP) issued a positive opinion that opebacan (NEUPREX(R)) be granted Orphan Medicinal Product
designation in meningococcal disease.