Astrazeneca approved countries
Astrazeneca approved countries. Astrazeneca is the 7th largest ethical multinational pharmaceutical company in the Philippines. Aug 16, 2024 · AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Mar 28, 2022 · AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg. Tezspire pre-filled pen Jun 20, 2024 · AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. Dec 30, 2020 · The Oxford-AstraZeneca vaccine, on the other hand, makes up the bulk of the 2 billion vaccine doses secured by COVAX, a consortium of 190 world governments formed to help ensure COVID-19 vaccines AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Sep 20, 2022 · AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19. The vaccine has already been approved in more than 70 countries, but clearance from American regulators Jun 3, 2024 · Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan. AstraZeneca is an established leader in respiratory care, and its inhaled and biologic medicines reached more than 53 million patients in 2019. The Medicines and Healthcare products Regulatory Agency (MHRA) began a review of efficacy and safety data on 27 November 2020, [ 132 ] followed by approval for use on 30 December 2020, becoming the second vaccine approved for use in the Jun 13, 2022 · The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim recommendations for use of the Oxford/AstraZeneca COVID-19 vaccine (ChAdOx1-S [recombinant] vaccine). Notes. The Phase III trial in SLE using subcutaneous delivery has been initiated and additional Phase III trials are planned for lupus nephritis, cutaneous lupus erythematosus and myositis. In Japan, this is the third approved indication for Tagrisso following previous approvals for 2nd-line T790M and 1st-line EGFRm NSCLC in March 2016 and August 2018, respectively. Eligible patients will have progressed on Feb 15, 2021 · A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India. COVID-19 Vaccine AstraZeneca COVID-19 Vaccine AstraZeneca (ChAdOx1-S [Recombinant]) was co-invented by the University of Oxford and its spin-out company, Vaccitech. In January 2021, India approved the use of the Oxford–AstraZeneca vaccine, paving the way for a mass immunisation campaign in the world's second most populous country. com Feb 15, 2021 · AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation or emergency use in more than 50 countries, with the WHO EUL now accelerating the pathway to access in up to 145 countries through the COVAX Facility. [107] Oct 27, 2021 · The AstraZeneca COVID-19 vaccine offers another option for vaccination against COVID-19 in some countries. The AstraZeneca COVID-19 vaccine is not approved for use in the United States yet. Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi has been approved for patients with mismatch repair proficient (pMMR Jul 17, 2023 · AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Tezspire is the only biologic approved for severe asthma with no phenotype (e. It uses a replication May 5, 2022 · AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of Aug 13, 2024 · Enhertu (5. Jun 12, 2024 · AstraZeneca’s Farxiga (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycaemic control in paediatric patients with type-2 diabetes (T2D) aged 10 years and older. Apr 29, 2024 · AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended for approval in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based Feb 19, 2021 · The wait has angered many pundits on social media, who call for immediate approval for the AstraZeneca vaccine. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries. S. Feb 7, 2023 · Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca. Mar 16, 2021 · Multiple countries have paused the use of AstraZeneca's COVID-19 vaccine as a precaution while investigators look into cases of blood clots among vaccinated people. In some countries, health care professionals and patients can visit local AstraZeneca websites to find out more about our medicines. 10,11 Jun 5, 2021 · Our medicines at AstraZeneca are approved in individual countries for specific uses, and the information we provide for patients is governed by local regulations. Aug 25, 2022 · Tagrisso is approved to treat early-stage lung cancer in more than 85 countries, including in the US, EU and China, and additional global regulatory reviews are ongoing. Aug 16, 2024 · WILMINGTON, Del. Argentina Mar 25, 2024 · Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. Antigua and Barbuda. Discover the impact you could have in our world-leading business. 2 Farxiga was previously approved in the US in adults with T2D as an adjunct to diet and exercise Mar 11, 2022 · LYNPARZA is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial. Aug 14, 2024 · AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) have been approved in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer. 2 Fasenra is currently approved as an add-on maintenance treatment for SEA in more than 80 countries, including the US, Japan, EU and now China. Sep 23, 2022 · Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc. 4-6. Regulatory applications are also currently under review in several other countries based on the TOPAZ-1 results. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi–GSK. Approved indications include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. As a global organisation, we work together to bring life-changing medicines to millions of patients. Aug 4, 2022 · Lynparza is also approved in the US, EU, Japan, and many other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial. For Media contacts, click here. 15-18 It is also approved in children and adolescents ages 6 and above in the US and Japan. wego. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. Mar 22, 2021 · The AstraZeneca vaccine was administered last week at the military hospital of Milan. eosinophilic or allergic) or biomarker limitation within its approved label. 1 The FDA approval was based on positive results from the paediatric T2NOW Phase III trial. Jul 5, 2024 · Tagrisso is approved as monotherapy in more than 110 countries including in the US, EU, China and Japan. 4mg/kg) is approved in more than 35 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally-approved test, and who have received a prior systemic therapy based on the results from the Mar 29, 2021 · But AstraZeneca is participating in the COVAX program to provide doses to low- and middle-income countries for no profit, and FDA approval is a global gold-standard for safety of medications. In the EU, this indication also includes patients with locally advanced breast cancer. [1] See full list on blog. In some cases, health care professionals and patients can visit local AstraZeneca websites to find out more about our medicines. com and follow the Company on Twitter @AstraZeneca. “The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to Jul 1, 2024 · Lynparza is currently approved in a number of countries across multiple tumour types, including maintenance treatment of platinum-sensitive relapsed ovarian cancer and as both monotherapy and in combination with bevacizumab for the 1st-line maintenance treatment of BRCA-mutated (BRCAm) and homologous recombination repair deficient (HRD Nov 17, 2023 · AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Oct 4, 2019 · Fasenra is AstraZeneca’s first respiratory biologic, now approved as an add-on maintenance treatment in severe eosinophilic asthma in the US, EU, Japan and other countries, with further regulatory reviews ongoing. Feb 2, 2023 · AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Aug 20, 2024 · The safety and tolerability profile for benralizumab in the MIRACLE trial was consistent with the known safety profile of the medicine. The first country to issue a temporary or emergency approval for the Oxford–AstraZeneca vaccine was the UK. AstraZeneca Singapore is one of Singapore’s leading biopharmaceutical companies that aim to make a difference in the healthcare industry by touching and saving as many lives as we can through our Aug 18, 2023 · Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or May 7, 2021 · WHO today listed the Sinopharm COVID-19 vaccine for emergency use, giving the green light for this vaccine to be rolled out globally. The other vaccine approved by Afghanistan is Janssen. Jun 25, 2024 · Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan. Contacts For details on how to contact the Investor Relations Team, please click here. It was announced that the Oxford–AstraZeneca shot would be made locally by the Serum Institute of India (SII) with a brand name COVISHIELD. Download the NBC News app for breaking news and politics Oct 24, 2022 · Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “With this first regulatory approval for Imjudo, patients with unresectable liver cancer in the US now have an approved dual immunotherapy treatment regimen that harnesses the potential of CTLA-4 inhibition in a unique combination with a PD-L1 inhibitor to Sep 5, 2022 · AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type . g. 4mg/kg) is approved in more than 35 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally-approved test, and who have received a prior systemic therapy based on the results from the Jan 10, 2018 · In November 2017, the US Food and Drug Administration (FDA) approved Fasenra for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India. 8 Fasenra is also under regulatory review in Japan and several other countries, with expected regulatory decisions in H1 2018. The following countries have given Covishield the go-ahead so far: Afghanistan. Mar 27, 2024 · AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in Japan for the treatment of adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone receptor (HR)-positive, HER2-negative breast cancer following progression after treatment with endocrine therapy. com and follow the Company on social media @AstraZeneca. 4mg/kg) is approved in more than 35 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial Jan 26, 2023 · AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant Oct 23, 2023 · AstraZeneca and Daiichi Sankyo’s (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. As a leader in rare diseases for nearly 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery Dec 28, 2022 · Imfinzi is also approved in combination with Imjudo and chemotherapy in metastatic non-small cell lung cancer in the US and Japan; in combination with chemotherapy in locally advanced or metastatic BTC in the US, Japan and several other countries; in combination with Imjudo in unresectable HCC in the US and Japan; as monotherapy in unresectable Jul 19, 2022 · Enhertu (5. Nov 14, 2023 · Imfinzi plus chemotherapy is approved in the US, EU (1st-line), Japan and other countries for the treatment of adults with locally advanced or metastatic BTC. Nov 16, 2021 · AstraZeneca continues to engage with governments, multilateral organisations and collaborators to ensure broad and equitable access to the vaccine. “I think we should approve AstraZeneca for [people] under 45 ASAP,” wrote Derek Jan 18, 2022 · Countries that have approved Covishield. High local and global confidence is essential to ensure a successful vaccination Aug 6, 2022 · AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. As a leader in rare diseases for more than 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery Apr 5, 2024 · ENHERTU (5. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). Jan 13, 2022 · Vaxzevria, the coronavirus vaccine developed by international pharma giant AstraZeneca, is currently approved in 134 countries worldwide, three more than the U. • COVID-19 Vaccine (ChAdOx1-S [recombinant]), AstraZeneca AB: 15 April 2021 Date of prequalification (PQ): not applicable National regulatory authorities (NRAs) can use reliance approaches for in-country authorization of vaccines based on WHO PQ/EUL or emergency use authorizations by stringent regulatory authorities (SRAs). You may access the guidance document here. Our medicines are approved in individual countries for specific uses and the information we provide for patients is governed by local regulations. Jan 13, 2023 · AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (FDA) on self-administration and the new pre-filled pen in the first half of 2023. Jun 17, 2024 · Imfinzi is also approved in a number of countries in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). It uses a replication Jan 30, 2017 · Outside of the US, budesonide/formoterol has been approved for use in over 100 countries for the regular treatment of asthma, where use of a combination (ICS and LABA) is appropriate, either as Symbicort Turbuhaler or as Symbicort pMDI, and in the majority of countries it is approved from 6 years and above. Our global locations. Jan 26, 2021 · AstraZeneca in Respiratory & Immunology Respiratory & Immunology is one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Apr 6, 2024 · Enhertu (5. , August 16, 2024 – AstraZeneca’s IMFINZI ® (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. The other vaccines approved by Antigua and Barbuda are Sputnik V, Pfizer, AstraZeneca, Sinopharm and Janssen. May 23, 2022 · For these reasons the AstraZeneca vaccine is vital for Ghana, along with many other lower-income countries. 1 Feb 16, 2022 · Saphnelo was recently approved in the US, Japan and Canada for the treatment of SLE, and regulatory reviews are ongoing in additional countries. -German joint venture Feb 15, 2021 · Today WHO listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. Feb 26, 2021 · Important details about the newly approved Oxford-AstraZeneca vaccine for COVID-19, like how well it works and what we've learned from other countries already using it. ibwjnd qkj lbgb dnaaios hadsp wycy odzpi gezbe xpftr voru