New EMA approvals

May 27, 2014

THE European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended varying levels of marketing authorisation for six new products. The approvals are for Gazyvaro (obinutuzumab), Plegridy (peginterferon beta-1a), Nuwiq (simoctogog alfa), Simbrinza (brinzolamide / brimonidine tartrate) and Envarsus (tacrolimus). Additionally, the CHMP recommended extensions of indications for Arzerra (ofatumumab), Halaven (eribulin mesylate) and Vfend (Voriconazole). The CHMP also recommended a conditional marketing authorisation for Translarna (ataluren), an orphan medicine for the treatment of Duchenne muscular dystrophy caused by nonsense mutations. It is to be used for patients aged five years or older who are able to walk.

The above article was sent to subscribers in Pharmacy Daily's issue from 27 May 14
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 27 May 14

Other recent headlines

New standards for nicotine vapes
Friday | Jun 20 2025
THE Therapeutic Goods Administration (TGA) has advised that starting 01 Jul 2025, strengthened standards will come into effect for all therapeutic vaping goods for smoking cessation and nicotine dependence, with existing supplies in pharmacies likely to be affected.

PATY2025 state winners
Friday | Jun 20 2025
THE Pharmacy Guild of Australia National President, Professor Trent Twomey, was delighted to announce that eight pharmacy assistants representing each Australian state and territory have been selected to compete for the national title of the 2025 Pharmacy Guild of Australia/Maxigesic Pharmacy Assistant of the Year Award (PATY).

MOU to advance Aussie life sciences
Friday | Jun 20 2025
MACQUARIE University and Vitex Pharmaceuticals have signed a Memorandum of Understanding (MOU) to establish a long-term strategic partnership, with the aim of advancing Australia’s life sciences industry.

SEARCH PHARMACY DAILY

Featured video
MORE VIDEOS

Recent issues

PD for Fri 20 Jun 2025
PD for Thu 19 Jun 2025
PD for Wed 18 Jun 2025
PD for Tue 17 Jun 2025
PD for Mon 16 Jun 2025
SEE MORE ISSUES

INDUSTRY JOB VACANCIES

Pharmacist in Charge – SA
Pharmacist Manager – WA
Compounding Pharmacist – Melbourne
Pharmacist in Charge – QLD North
Pharmacist – Sydney North
SEE MORE JOBS

Pharmacy Daily is Australia's favourite online publication dedicated to the pharmacy industry. The publication launched in March 2007 and is distributed every day by email to pharmacists across the country.

PHARMACY DAILY NEWS
Headlines

Jobs

New Products

Events Calendar

FEEDS
News Items RSS feed

PD Issues RSS feed

All content RSS feed

Content & Media
Pharmacy Daily TV

OUR SITES
Sitemap

Travel Daily

Travel Bulletin

Cruise Weekly

Business Events News

Pharmacy Daily

ADVERTISE WITH US
Advertise in Pharmacy Daily

Privacy

ADMIN
Log in

SUBSCRIBE
Sign up for FREE

Subscription Information

"Water, air, and cleanness are the chief articles in my pharmacy." - Napoleon Bonaparte

Copyright © 2025 Pharmacy Daily

Subscribe to Pharmacy Daily now!

FREE Pharmacy Daily subscription - never miss another story!

Name*
First Last
Email*

Profession
Company

Address
City State / Province / Region ZIP / Postal Code Country

By submitting this form I hereby certify that I understand that Pharmacy Daily is a publication for health professionals.
Email
This field is for validation purposes and should be left unchanged.

to top

Pharmacy Daily | New EMA approvals

New EMA approvals

Other recent headlines

New standards for nicotine vapes

PATY2025 state winners

MOU to advance Aussie life sciences

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES