Article 5(3) opinions on any scientific matter: human medicines

This page lists the opinions drawn up by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) under Article 5(3) of the Regulation establishing the EMA, concerning any scientific matter related to the evaluation of medicines for use in humans.

The Committee must draw up such an opinion at the request of the Executive Director of the EMA or of the European Commission. It may also draw up an opinion following a request from a Member State.

Where the scientific issue concerns both human and veterinary medicines, the Committee may adopt a common opinion with the Committee for Medicinal Products for Veterinary Use (CVMP).

Requests for this type of scientific opinion fall under Article 5(3) of Regulation (EC) No 726/2004.

Use of Paxlovid (PF-07321332 and ritonavir) for treating COVID-19

Paxlovid (PF-07321332 and ritonavir) - COVID-19 - Article-5(3) procedure: Assessment report

AdoptedReference Number: EMA/783153/2021

Paxlovid (PF-07321332 and ritonavir) - COVID-19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring

Adopted

• EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19 (16/12/2021)

Use of Lagevrio (also known as molnupiravir or MK 4482) for treating COVID-19

Questions and answers on the refusal of the marketing authorisation for Lagevrio (molnupiravir)

AdoptedReference Number: EMA/82948/2023 Rev.1

Lagevrio (also known as molnupiravir or MK 4482) - COVID-19 - Article-5(3) procedure: Assessment report

AdoptedReference Number: EMA/719664/2021 Corr. 1

Lagevrio (also known as molnupiravir or MK 4482) - COVID-19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring

Adopted

• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2023: EMA's CHMP recommends the refusal of a marketing authorisation for Lagevrio (molnupiravir) (24/02/2023)
• EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19 (14/12/2021)
• EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19 (23/11/2021)
• EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19 (19/11/2021)

Use of sotrovimab (VIR-7831) for treating COVID-19

Sotrovimab (also known as VIR-7831 and GSK4182136) - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring

Adopted

Sotrovimab (also known as VIR-7831 and GSK4182136) - COVID19 - Article-5(3) procedure: Assessment report

AdoptedReference Number: EMA/304600/2021

• EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19 (21/05/2021)

Use of Vaxzevria to prevent COVID-19

Use of Vaxzevria to prevent COVID-19 - Article-5(3) procedure: Final assessment report

AdoptedReference Number: EMA/530434/2021

Use of Vaxzevria to prevent COVID-19 - Article-5(3) procedure: Assessment report

AdoptedReference Number: EMA/CHMP/214855/2021

Interim Opinion of the Committee for Medicinal products for Human Use pursuant to Article 5(3) of Regulation (EC) No 726/2004 for Vaxzevria

AdoptedReference Number: EMA/CHMP/228681/2021

Letter from Commissioner Kyriakides asking EMA to follow up on Vaxzevria opinion after Council discussion

• Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
• Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021 (17/09/2021)
• AstraZeneca’s COVID-19 vaccine: benefits and risks in context (23/04/2021)
• AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets (14/04/2021)

Use of regdanvimab for the treatment of COVID-19

Regdanvimab for the treatment of COVID-19 (Celltrion) - COVID-19 - Article-5(3) procedure: Assessment report

AdoptedReference Number: EMA/192245/2021

Celltrion use of regdanvimab for the treatment of COVID-19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients Targeted and conditions for safety monitoring addressed to Member States

AdoptedSummary:

Conditions of use, conditions for distribution and patients Targeted and conditions for safety monitoring addressed to Member States

• EMA issues advice on use of regdanvimab for treating COVID-19 (26/03/2021)

Use of bamlanivimab and etesevimab for the treatment of COVID-19

Eli Lilly and Company Limited antibody combination (bamlanivimab / etesevimab - COVID19 - Article-5(3) procedure: Assessment report

AdoptedReference Number: EMA/177113/2021

Eli Lilly and Company Limited antibody combination (bamlanivimab / etesevimab - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring

• EMA issues advice on use of antibody combination (bamlanivimab / etesevimab) (05/03/2021)

Use of casirivimab and imdevimab for the treatment of COVID-19

REGN-COV2 antibody combination (casirivimab / imdevimab) - COVID19 - Article-5(3) procedure: Assessment report

Reference Number: EMA/142650/2021

REGN-COV2 antibody combination (casirivimab / imdevimab) - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring

• EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab) (26/02/2021)

Use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation

EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation

Reference Number: EMA/483739/2020

Dexamethasone - COVID19 - Article-5(3) procedure: proposals for product information

Summary:

Proposals for product information

Dexamethasone - COVID19 - Article-5(3) procedure: Assessment report

Reference Number: EMA/509632/2020

• EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation (18/09/2020)

Nitrosamine impurities in human medicinal products (Updated 18/02/2021)

European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines

Reference Number: EMA/425645/2020

Nitrosamines EMEA-H-A5(3)-1490 - Assessment report

AdoptedReference Number: EMA/369136/2020

Nitrosamine impurities - Final outcome of Article 5(3)

Reference Number: EMA/341963/2020

Nitrosamine impurities - Interim outcome of Article 5(3)

Reference Number: EMA/511347/2019

EMA to provide guidance on avoiding nitrosamines in human medicines

Reference Number: EMA/500009/2019Summary:

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances.

Nitrosamines EMEA-H-A5(3)-1490 - Information on nitrosamines for marketing authorisation holders - Obsolete

AdoptedReference Number: EMA/189634/2019

Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers on 'Information on nitrosamines for marketing authorisation holders' - Obsolete

AdoptedReference Number: EMA/CHMP/428592/2019 Rev. 3

• EMA finalises opinion on presence of nitrosamines in medicines (09/07/2020)
• EMA advises companies on steps to take to avoid nitrosamines in human medicines(26/09/2019)
• EMA to provide guidance on avoiding nitrosamines in human medicines(13/09/2019)

Use of direct oral anticoagulants (DOACs)

Assessment report for Article-5(3) procedure: direct oral anticoagulants (DOACs)

AdoptedReference Number: EMA/194375/2020

No change is needed in use of direct oral anticoagulants following EMA-funded study

Reference Number: EMA/94424/2020

Direct oral anticoagulants (DOACs) - EMA starts review of study on bleeding risk with direct oral anticoagulants

Reference Number: EMA/37941/2019

Systemic use of gentamicin

Assessment report for Article-5(3) procedure: Gentamicin

AdoptedReference Number: EMA/805330/201

Suitability of the zebrafish model for evaluating effects of norethisterone and ethinylestradiol

Assessment report for Article-5(3) procedure: norethisterone and ethinylestradiol

AdoptedReference Number: EMA/745160/2018

Assessment report for Article-5(3) procedure: norethisterone and ethinylestradiol (EMEA/H/A-5(3)/1477)

AdoptedReference Number: EMA/245512/2019 Corr.

Prescription status of desloratadine-containing products

Assessment report for Article-5(3) procedure: desloratadine-containing medicinal products

AdoptedReference Number: EMA/421768/2017

Revision of manufacturing and quality requirements for polymyxin-based products

Assessment report for Article-5(3) procedure: Polymyxin-based products

AdoptedReference Number: EMA/CHMP/153652/2015Summary:

Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted.

Available data for Ebola treatments under development

Assessment report for Article-5(3) procedure: Medicinal products under development for treatment of Ebola

AdoptedReference Number: EMA/129754/2016Summary:

CHMP assessment report - Review under Article 5(3) of Regulation (EC) No 726/2004. Medicinal products under development for the treatment of Ebola, Procedure no: EMEA/H/A-5(3)/1410

Interim assessment report for Article-5(3) procedure: Medicinal products under development for treatment of Ebola

AdoptedReference Number: EMA/756544/2014 Rev. 1Summary:

Procedure no: EMEA/H/A-5(3)/1410

Short-term paediatric use of propylene glycol

Assessment report for Article-5(3) procedure: Propylene glycol in medicinal products for children

AdoptedReference Number: EMA/175205/2014Summary:

Assessment report for Article-5(3) procedure: Propylene glycol in medicinal products for children. Procedure No. EMEA/H/A-5(3)/1317

Use of GLP-1 based therapies and risk for inflammation of the pancreas

Assessment report for Article-5(3) procedure: GLP-1-based therapies

AdoptedReference Number: EMA/474117/2013

• Investigation into GLP-1-based diabetes therapies concluded (26/07/2013)
• Pancreatic safety of incretin-based drugs - FDA and EMA assessment

Use of reworked batches of Octagam

Assessment report for Article-5(3) procedure: Octagam and associated names

AdoptedReference Number: EMA/227216/2012

Equivalence between teicoplanin generics and the reference product

Assessment report for Article-5(3) procedure: Teicoplanin-containing medicinal products

AdoptedReference Number: EMA/194668/2013

Supply chain for protamine-containing medicinal products

Assessment report for Article-5(3) procedure: Protamine-containing medicinal products

AdoptedReference Number: EMA/741250/2012

• European Medicines Agency completes review of protamine-containing medicines (16/11/2012)

Hypothesis on Pandemrix and development of narcolepsy

Assessment report for Article-5(3) procedure: Immunological differences of pandemic vaccines (review of hypothesis on Pandemrix and development of narcolepsy)

Reference Number: EMA/687578/2012

• European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy (19/10/2012)

Non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk

Assessment report for Article-5(3) procedure: Non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk

Reference Number: EMA/696137/2012

Questions and answers on the review of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk

Reference Number: EMA/653433/2012

• European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs (19/10/2012)

Anti-tuberculosis medicines used in children: review of dosing recommendations from the World Health Organization (WHO)

Assessment report for Article-5(3) procedure: Anti-tuberculosis medicinal products containing isoniazid, rifampicin, pyrazinamide, ethambutol, rifabutin: posology in children

AdoptedReference Number: EMA/227191/2012Summary:

Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted.

• European Medicines Agency concludes review of dose recommendations for anti-tuberculosis medicines used in children (17/02/2012)

Angiotensin-II-receptor antagonists and the risk of cancer

Assessment report for Article-5(3) procedure: Angiotensin II (type-1) receptor antagonists and risk of cancer

AdoptedReference Number: EMEA/H/A-5(3)/1274

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer

Reference Number: EMA/CHMP/834168/2011

• European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive (20/10/2011)

Particles on silicone tubing of diphtheria and tetanus toxoid (DT) and diphtheria/tetanus toxoid/pertussis (DTwP) antigen bulk containers

Assessment report under Article 5(3) for particles on silicone tubing of diphtheria and tetanus toxoid (DT) and diphtheria/tetanus toxoid/pertussis (DTwP) antigen bulk containers

Reference Number: EMA/474456/2011

Potential off-label use of celecoxib in patients with familial adenomatous polyposis

Assessment report for celecoxib for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis, as an adjunct to surgery and further endoscopic surveillance

AdoptedReference Number: EMA/416998/2011

Questions and answers on the potential off-label use of celecoxib in patients with familial adenomatous polyposis

Reference Number: EMA/CHMP/376406/2011Summary:

The European Medicines Agency has completed a review of the use of celecoxib for reducing the number of polyps in patients with familial adenomatous polyposis (FAP).

• European Medicines Agency concludes on use of celecoxib in familial adenomatous polyposis (20/05/2011)

Presence of endotoxins in Baxter peritoneal dialysis solutions

Assessment report for Article-5(3) procedure: Presence of endotoxins in Baxter peritoneal dialysis solutions

Reference Number: EMA/833156/2010

Questions and answers on the presence of endotoxins in Baxter peritoneal dialysis solutions

Reference Number: EMA/818936/2010

• European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions (17/12/2010)

Detection of unexpected viral DNA in live attenuated vaccines

Assessment report for Article-5(3) procedure: Detection by a highly sensitive new polymerase-chain-reaction technique of genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines

AdoptedReference Number: EMEA/H/A-5(3)/1269

Questions and answers on the detection of unexpected viral DNA in live attenuated vaccines

Reference Number: EMA/718290/2010

• European Medicines Agency confirms that presence of unexpected viral DNA in live attenuated vaccines does not raise public health concerns (18/11/2010)

Bisphosphonates and osteonecrosis of the jaw

Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on bisphosphonates and osteonecrosis of the jaw

Reference Number: EMEA/CHMP/292474/2009, EMEA/H/A-5(3)/1130

Request for a scientific opinion letter

CHMP assessment report on bisphosphonates and osteonecrosis of the jaw - Procedure under Article 5(3) of Regulation (EC) No 726/2004

Reference Number: EMEA/CHMP/291125/2009

Questions and answers on the review of bisphosphonates and the risk of osteonecrosis of the jaw

Reference Number: EMEA/CHMP/292475/2009

Novel influenza (H1N1) outbreak: Tamiflu (oseltamivir) and Relenza (zanamivir)

Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) no 726/2004, on novel influenza (H1N1) outbreak, Tamiflu (oseltamivir), Relenza (zanamivir)

Reference Number: EMEA/CHMP/278838/2009

CHMP assessment report on novel influenza (H1N1) outbreak, Tamiflu (oseltamivir), Relenza (zanamivir)

Reference Number: EMEA/CHMP/287662/2009

Questions and answers on the use of antiviral medicines in case of novel influenza A/H1N1 pandemic

Reference Number: EMEA/273535/2009

• European Medicines Agency gives guidance for use of antiviral medicines in case of a novel influenza A/H1N1 pandemic (08/05/2009)

Conventional antipsychotics

Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on conventional antipsychotics

Reference Number: EMEA/CHMP/590563/2008

CHMP assessment report on conventional antipsychotics procedure under Article 5(3) of Regulation (EC) No 726/2004

Reference Number: EMEA/CHMP/590557/2008

Questions and answers on the review of the use of conventional antipsychotic medicines in elderly patients with dementia

Reference Number: EMEA/637512/2008

Antidepressants

Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on antidepressants

Reference Number: EMEA/CHMP/266022/2008

Letter on efficacy of antidepressants

CHMP assessment report on antidepressants under Article 5(3) of Regulation (EC) No 726/2004

Reference Number: EMEA/CHMP/266019/2008

Medicinal products containing or derived from heparin

Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on heparins

Reference Number: EMEA/CHMP/271967/2008

CHMP assessment report for medicinal products containing or derived from heparin under Article 5(3) of Regulation (EC) No 726/2004

Reference Number: EMEA/CHMP/278280/2008

Questions and answers on heparins

Reference Number: EMEA/276814/2008

• European Medicines Agency recommends measures to manage contamination of heparin-containing medicines (05/06/2008)

Potential risk of carcinogens, mutagens and substances toxic to reproduction when these substances are used as excipients of medicinal products for human use

CHMP scientific Article-5(3) opinion on the potential risks of carcinogens, mutagens and substances toxic to reproduction when these substances are used as excipients of medicinal products for human use

Reference Number: EMEA/CHMP/SWP/146166/2007

Adequacy of guidance on the elderly regarding medicinal products for human use

Adequacy of guidance on the elderly regarding medicinal products for human use

Reference Number: EMEA/498920/2006

Non-selective non-steroidal anti-inflammatory drugs (NSAIDs)

Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, for non-selective non-steroidal anti-inflammatory drugs (NSAIDs)

Reference Number: EMEA/CHMP/410051/2006

Letter on request for opinion on non-selective NSAIDs under Article 5(3) of Regulation (EC) No 726/2004

Public CHMP assessment report for medicinal products containing non-selective non-steroidal anti-inflammatory drugs (NSAIDs)

AdoptedReference Number: EMEA/CHMP/442130/2006

Questions and answers on the review of non-selective non-steroidal anti-inflammatory drugs

AdoptedReference Number: EMEA/410862/2006

• European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs (24/10/2006)