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Committee for Medicinal Products for Human Use (CHMP)

EMA’s human medicine committee (CHMP) meeting highlights, July 2021

26 July 2021 | By Anna Begley (European Pharmaceutical Review)

The Committee for Medicinal Products for Human Use (CHMP) recommended two medicines for approval and provided a negative opinion on Nouryant.

patient on respirator surrounded by doctors in protective suits

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EMA recommendations on compassionate use of remdesivir for COVID-19

6 April 2020 | By Hannah Balfour (European Pharmaceutical Review)

The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.

pile of various coloured tablets in blister packs with syringes on top

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Committee for Medicinal Products for Human Use (CHMP) meeting highlights

30 March 2020 | By Hannah Balfour (European Pharmaceutical Review)

A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.

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CHMP recommends fifteen therapeutics at latest meeting

3 February 2020 | By European Pharmaceutical Review

The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.

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EC approves ustekinumab to treat plaque psoriasis in patients age six to 11

28 January 2020 | By Victoria Rees (European Pharmaceutical Review)

The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.

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EMA recommends five drugs for approval after December meeting

16 December 2019 | By Victoria Rees (European Pharmaceutical Review)

The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.

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EMA releases guidance to companies on avoiding nitrosamines in drugs

27 September 2019 | By Victoria Rees (European Pharmaceutical Review)

The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.

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EMA CHMP recommends seven medicines for approval

24 September 2019 | By Victoria Rees (European Pharmaceutical Review)

The EMA has suggested seven treatments to be granted marketing authorisations and also advocated indication extension for eight drugs.

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Terrosa^® osteoporosis biosimilar treatment launched in Europe

21 August 2019 | By Victoria Rees (European Pharmaceutical Review)

A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.

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Imbruvica^® granted expanded use from European Commission

14 August 2019 | By Victoria Rees (European Pharmaceutical Review)

The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.

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EMA recommends Vitrakvi for EU marketing authorisation

29 July 2019 | By Victoria Rees (European Pharmaceutical Review)

The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.

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EMA releases medicinal approval recommendations

1 July 2019 | By European Pharmaceutical Review

The EMA has given its approval recommendation to three drugs and announced negative opinions for approval on others.

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EMA recommends authorisation to Amglidia for neonatal diabetes

27 February 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

Amglidia is a new formulation of glibenclamide, specifically developed for use in newborns, toddlers and children...

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Enzyme replacement therapy to treat alpha-mannosidosis

29 January 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

The EMA has recommended granting a marketing authorisation in the EU for Lamzede a long-term enzyme replacement therapy for alpha-mannosidosis...

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Novartis receives EU approval for ribociclib

24 August 2017 | By Dr Zara Kassam (European Pharmaceutical Review)

Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer

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Committee for Medicinal Products for Human Use (CHMP)