Circovac : EPAR - Summary for the public Reference Number: EMA/286116/2007
P/0154/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2- yl)oxy)phenyl)...(EMEA-003371-PIP01-22) Reference Number: EMA/170256/2023
The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count). The most common serious side effects (seen in more than 20% of patients) include …
Marketing-authorisation holders that have received a deferral on a PIP are obliged to submit annual reports to the Agency. These reports should provide an update on progress with paediatric studies in accordance with the decision of the Agency agreeing the …
The forms and templates should be downloaded and saved first before being completed. To report any technical issues with the form, please use the EMA Service Desk portal. It is mandatory to use the latest published version of all templates and forms unless …
If you need to contact EMA about an ongoing paediatric procedure in IRIS, send your message as a reply to the latest email received from IRIS relating to that procedure. Please make sure not to change the subject field when replying so your message is …
EMA is running a pilot for a 'stepwise PIP' agreement which would introduce a partial development programme supporting the authorisation of innovative medicines for children. This programme would be conditional on the development of a full PIP once …
As of 4 June 2024, applicants should use the IRIS platform for the following types of procedure: Initial paediatric investigation plan (PIP) Modification of an agreed PIP Product-specific waiver Compliance check Annual report on paediatric deferred …
Androgen receptor modulator, of oestrogen receptor modulator, of growth and sex hormone as well as their releasing or inhibiting factors, and of sex hormone-metabolism modulator medicinal products Breast malignant neoplasms, prostate malignant neoplasms …
The N.C. Department of Environmental Quality’s Division of Coastal Management (DCM) is accepting public comments on the Coastal Resources Commission Science Panel’s draft Sea Level Rise update. Public comments will be accepted until July 3, 2024, at 5 p.m …
SALT LAKE CITY, June 03, 2024 (GLOBE NEWSWIRE) -- After more than a decade of leadership, Savage announced that President and Chief Executive Officer Kirk Aubry will be retiring from the company on December 31, 2024. Chief Operating Officer Jeff Roberts is …
HENDERSON, Nev., June 03, 2024 (GLOBE NEWSWIRE) -- Nika Pharmaceuticals, Inc. (OTCMKTS: NIKA) introduces its plans to develop the company into a sustainable business project that will consistently grow, bring good profits and provide dividends to its …
Men's Suit Market Size was valued at $12.6 billion in 2022, and is estimated to reach $20.2 billion by 2032, growing at a CAGR of 4.9% from 2023 to 2032. DELAWARE, WILMINGTON, UNITED STATES, June 3, 2024 /EINPresswire.com/ -- According to a new …
WappJet Introduces New and Innovative Features for WhatsApp Marketing Tools RANGPUR, RANGPUR, BANGLADESH, June 3, 2024 /EINPresswire.com/ -- WappJet, a leading provider of WhatsApp marketing tools, is excited to announce the launch of its latest …
Amalga Group, led by CEO Jens Erik Gould, specializes in nearshore outsourcing and provides comprehensive support amid changing global manufacturing dynamics. AUSTIN, TX, USA, June 3, 2024 /EINPresswire.com/ -- Amidst the global restructuring in …
Maryland Addiction Recovery Center emphasizes the critical role of its Extended Care Community Living Treatment Program in supporting individuals. TOWSON, MD, USA, June 3, 2024 /EINPresswire.com/ -- Maryland Addiction Recovery Center (MARC) emphasizes …
Rockford, Illinois, June 03, 2024 (GLOBE NEWSWIRE) -- ROCKFORD, Illinois – Rockford Mutual Insurance Company (RMIC) places very high value in our independent agency force because we believe insurance is more than a policy, it’s a promise. It is with great …
OKW’s stylish DIATEC plastic enclosures for wall-mount and table-top electronics are now available in two standard colors: off-white (RAL 9002) and lava. BRIDGEVILLE, PENNSYLVANIA, USA, June 3, 2024 /EINPresswire.com/ -- These highly attractive …
Fibergrate Composite Structures Increases Support to the United Kingdom and Ireland with Local Territory Sales Managers DALLAS, TX, UNITED STATES, June 3, 2024 /EINPresswire.com/ -- Fibergrate Composite Structures, a leading global manufacturer of glass …
The global hard seltzer industry garnered $3.83 billion in 2019, and is expected to garner $10.92 billion by 2027, growing at a CAGR of 12.7% from 2021 to 2027. WILMINGTON, DELAWARE, UNITED STATES, June 3, 2024 /EINPresswire.com/ -- Surge in prevalence …
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