EU Panel Adopts Positive Opinion For Number Of New Medicines
18 März 2011 - 1:43PM
Dow Jones News
The European Medicines Agency, or EMA, Friday said the Committee
for Medicinal Products for Human Use, or CHMP, adopted positive
opinions recommending the granting of marketing authorisations for
a number of new medicines.
MAIN FACTS:
-Adopted positive opinions recommending the granting of
marketing authorisations for:
*Eliquis (apixaban), from Bristol-Myers Squibb/Pfizer EEIG.
*Yellox (bromfenac), from Croma-Pharma GmbH.
*Zoely and IOA (nomegestrol acetate/estradiol), from Merck
Serono Europe Ltd and N.V. Organon.
-Committee gave also a positive opinion for Cinryze (C1
inhibitor, human), an orphan medicine from ViroPharma SPRL;
However, the CHMP noted that ViroPharma is considered the same
applicant as Sanquin, which holds marketing authorisations in some
European Union Member States for a medicine with the same
composition and pharmaceutical form and overlapping indications
with Cinryze; This may preclude the granting of a marketing
authorisation for Cinryze.
-Committee adopted positive opinions for applications for
extensions of therapeutic indications, adding new treatment options
for medicines that are already authorised in the E.U., for:
*Herceptin (trastuzumab), from Roche Registration Ltd.
*Lucentis (ranibizumab), from Novartis Europharm Ltd.
*Remicade (infliximab), from Janssen Biologics B.V.
*Revatio (sildenafil), an orphan medicine from Pfizer Ltd.
-Committee adopted a negative opinion for Vectibix
(panitumumab), from Amgen Europe B.V..
-Committee has been informed by Genzyme Europe B.V., the
marketing authorisation holder for Thyrogen (thyrotropin alfa),
that due to a manufacturing issue there will be a supply shortage
of this medicine until July 2011; Genzyme will only be able to
supply Thyrogen to meet approximately 45% of E.U. demand through to
July 2011.
-Committee completed an arbitration procedure initiated because
of disagreement among E.U. Member States regarding the
authorisation of the generic medicine Canazole (Clotrimazole Cream
1%), from Pinewood Laboratories Ltd.
-Committee recommended the harmonisation of the prescribing
information for Arimidex (anastrozole), from AstraZeneca.
-Committee has begun looking at the benefit-risk balance of the
antidiabetic pioglitazone-containing medicines, from Takeda Global
Research and Development Centre (Europe) Ltd.
-Committee has begun looking at the benefit-risk balance of the
orphan medicine Revlimid (lenalidomide), from Celgene Europe
Ltd.
-Committee has begun a review of Vivaglobin and associated names
(human normal immunoglobin for subcutaneous use), from CSL Behring,
following reports indicating that Vivaglobin may be associated with
thromboembolic events.
-Committee has begun looking at the results of a good clinical
practice, or GCP, inspection indicating that the clinical studies
performed as part of the marketing authorisation applications for
Novosis Goserelin, Goserelin cell pharm, Novimp and associated
names (goserelin), have not been GCP compliant.
-By Jana Weigand, Dow Jones Newswires; 44-20-7842-9314;
jana.weigand@dowjones.com
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