European Medicines Agency

European health body on alert over new Covid-19 variants: Official

"The EMA keeps monitoring the situation to better understand the trend of the new wave and to be prepared for new waves, which are always extremely difficult to predict," the official said.

Sep 03, 2022, 07:03 AM IST

European Union health regulator approves use of Pfizer’s Covid-19 pill for high-risk groups

The EMA`s recommendation was sent to the European Commission for a rapid decision applicable in all EU member states.

Jan 28, 2022, 08:28 AM IST

Amid Omicron scare, Europe rolls out Covid vaccine for kids aged 5-11

The European Union's medicines watchdog European Medicines Agency, last month, approved the Pfizer-BioNTech shot for five to 11-year-olds. Denmark and Austria began inoculating younger kids in November.

Dec 16, 2021, 15:19 PM IST

Good news for travellers, says Serum Institute CEO Adar Poonawalla as 16 European countries recognise Covishield

"It is indeed good news for travellers, as we see sixteen European countries recognising Covishield as an acceptable vaccine for entry," tweeted SII CEO Adar Poonawalla.

Jul 18, 2021, 07:09 AM IST

No application received for EU authorisation of Covishield: European Medicines Agency

"For the COVID-19 vaccine Covishield to be evaluated for use in the EU, the developer needs to submit a formal marketing authorisation application to EMA, which to date has not been received," the EMA said at a press briefing. 

Jul 17, 2021, 12:37 PM IST

Belgium recognises India-made Covishield vaccine, becomes 15th EU nation to do so

Belgium recognises AstraZeneca's Covishield vaccine, the Embassy of Belgium in India informed, making it the 15 European nation to do so.

Jul 09, 2021, 22:49 PM IST

Germany, Spain, seven other European countries list India-made Covishield on national travel list

The countries which have approved the Covishield vaccine include Switzerland, Austria, Germany, Slovenia, Greece, Estonia, Ireland, Spain and Estonia.

Jul 01, 2021, 14:05 PM IST

Serum Institute requests govt to take up inclusion of Covishield in EU vaccination passport

Sources said referring to Poonawalla's letter, the Director of Government and Regulatory Affairs at SII, Prakash Kumar Singh, has also sought Jaishankar's intervention at the highest level.

Jun 28, 2021, 23:05 PM IST

Covishield missing from European Union's 'virtual vaccine passport' list, govt to resolve matter

EU Digital COVID Certificate is digital proof that a person has either been vaccinated against COVID-19, received a negative test result, or recovered from COVID-19.

Jun 28, 2021, 16:45 PM IST

Serum Institute CEO Adar Poonawalla assures help to Indians amid reports of Covishield not qualifying for EU ‘Green Pass’

"I realise that a lot of Indians who have taken COVISHIELD are facing issues with travel to the E.U., I assure everyone, I have taken this up at the highest levels and hope to resolve this matter soon, both with regulators and at a diplomatic level with countries," said Adar Poonawalla.

Jun 28, 2021, 12:03 PM IST

Travel to Europe still a worry as India-made Covishield yet to get European Union 'Green Pass'

Even though Covishield has the WHO’s approval, the ‘Green Pass’ program only accommodates EMA-approved vaccines. The four COVID-19 vaccines approved by EMA are Comirnaty (Pfizer/BioNTech), Moderna, Vaxzervria (AstraZeneca-Oxford), Janssen (Johnson & Johnson).

Jun 28, 2021, 10:04 AM IST

Since 2012, China heart drug sold globally may have had impurity linked to cancer

The revelation that the problem likely dates back to changes in manufacturing processes at Zhejiang Huahai Pharmaceutical six years ago suggests many patients could potentially have been exposed to cancer risk.

Jul 18, 2018, 11:53 AM IST

Amsterdam wins battle to host EU medicines agency after Brexit

Amsterdam on Monday won a fierce fight to host the European Medicines Agency after it leaves London, securing one of the most prized spoils of Britain`s decision to leave the EU.

Nov 21, 2017, 00:48 AM IST

Sun Pharma, Samsung BioLogics ink $55.5 mn pact

As per the pact, Sun Pharma has appointed Samsung BioLogics to manufacture Tildrakizumab.

Jul 04, 2017, 14:34 PM IST

US FDA accepts application for psoriasis drug: Sun Pharma

Drug major Sun Pharmaceutical Industries on Wednesday said the US health regulator has accepted biologics licence application (BLA) for tildrakizumab for the treatment of psoriasis.

May 24, 2017, 11:49 AM IST

EU battle begins to win UK-based agencies after Brexit

European leaders will discuss for the first time at a summit on Saturday the battle to host two London-based EU agencies after Brexit, with a decision expected later this year, officials said.

Apr 28, 2017, 19:29 PM IST

Real Brexit talks will only start after June vote: EU Commission

The president of the European Commission believes "real" Brexit talks will only start after British snap elections called for June 8, an EU spokesman said on Wednesday.

Apr 19, 2017, 17:50 PM IST

GSK gets EU approval for first gene therapy for children

The world`s first life-saving gene therapy for children, developed by GlaxoSmithKline and Italian scientists, was approved for sale in Europe on Friday, in a step forward for the pioneering technology to fix faulty genes.

May 27, 2016, 22:54 PM IST

Stempeutics' Stempeucel gets Orphan Drug status in Europe

Shares of Cipla were trading at Rs 669.05 per scrip in the afternoon trade on BSE, up 2.86 percent from its previous close.

Jun 01, 2015, 14:31 PM IST

Lupin submits fresh studies for two products suspended by EMA

The Mumbai-based firm along with many other companies had received communication from EMA for suspension of Trimetazidine MR 35 mg and Cefpodoxime 200 mg tablets in January 2015.

May 26, 2015, 14:10 PM IST