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European Medicines Agency News

03 Sep 2022

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.

28 Jan 2022

European Union health regulator approves use of Pfizer’s Covid-19 pill

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

16 Dec 2021

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

The US was the first country to start vaccinating small kids USA has inoculated more than five million children aged five to 11

COVID-19 vaccine

18 Jul 2021

Good news: SII CEO Poonawalla as 16 European countries recognise Covishield

On Saturday, France lifted travel restrictions for fully vaccinated travellers. Indian government has been pushing European Union member countries to recognise both Covishield and Covaxin in order to ease travel for the people

COVID-19 vaccine

17 Jul 2021

No application received for EU authorisation of Covishield: EMA

EMA has approved only four vaccines namely, Comirnaty of Pfizer/BioNTech, Moderna's Spikevax, Vaxzervria by AstraZeneca-Oxford and Johnson & Johnson's Janssen. The SII’s CEO Adar Poonawalla had earlier said that the company is confident of receiving approval from the EMA.

COVID-19 vaccine

09 Jul 2021

Belgium recognises India's Covishield vaccine, becomes 15th EU nation to do so

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

COVID-19 vaccine

01 Jul 2021

Nine 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. Covishield and Covaxin vaccinated persons are allowed in the country, along with Sputnik and Moderna in Estonia.

COVID Vaccination

28 Jun 2021

SII asks govt to take up inclusion of Covishield in EU vaccination passport

Jaishankar said this might affect students, business travellers back and forth, and cause severe disruptions Poonawalla, in his letter, is learnt to have mentioned that nearly 30 crore people have already been vaccinated with Covishield in India

COVID Vaccination

28 Jun 2021

Covishield missing from European Union's 'virtual vaccine passport' list

Serum Institute of India had never applied to the European Medicine Agency Adar Poonawalla said he has taken up the matter at the highest levels Only 4 vaccines are allowed by European Medicines Agency for travel in European Union

COVID-19 vaccine

28 Jun 2021

Serum Institute CEO Adar Poonawalla assures help to Indians for this reason

The CEO of Serum Institute of India (SII) Adar Poonawalla on Monday assured the people of the nation that the issue is being with at the highest level. The statement comes amid the reports of the European Union’s new concept of Green Pass is doing rounds in media.

COVID-19 vaccine

28 Jun 2021

Travel to Europe still a worry as Covishield yet to get EU 'Green Pass'

The majority of people in India have received Covishield jabs. Even though Covishield has the WHO’s approval, the ‘Green Pass’ program only accommodates EMA-approved vaccines.

18 Jul 2018

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

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.

20 Nov 2017

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.

04 Jul 2017

Sun Pharma, Samsung BioLogics ink $55.5 mn pact

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

Sun Pharmaceutical Industries

24 May 2017

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.

28 Apr 2017

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.

19 Apr 2017

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.

GlaxoSmithKline

27 May 2016

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.

01 Jun 2015

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.

26 May 2015

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.

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