European Medicines Agency

The European Medicines Agency (EMA) assesses medicines for EU-wide (“centralised”) marketing authorisation. Its Committee for Medicinal Products for Human Use (CHMP) gives the scientific opinion, and the European Commission grants the licence. The assessment is published as a European public assessment report (EPAR). Since the 2007 Paediatric Regulation, a separate Paediatric Committee (PDCO) agrees each company’s paediatric investigation plan (PIP). The PIP sets which studies must be done in children aged 0–17, and PDCO can grant waivers or deferrals until adult data exist. Marketing authorisation itself stays with the CHMP (EMA PDCO page). For toddler eczema, the paediatric age limit on an EU label is therefore set by what the PIP studies covered and by what the company chose to file. After Brexit the UK licenses medicines separately through the MHRA, so UK and EU labels can differ.

European Medicines Agency [regulates] Dupilumab European Medicines Agency [regulates] JAK Inhibitors European Medicines Agency [relates] MHRA

Paediatric licences relevant to 1–4-year-olds.

• Tacrolimus (Protopic) has been authorised EU-wide since 28 February 2002 for moderate-to-severe AD that does not respond to, or tolerate, conventional treatment such as TCS. 0.03% is licensed from age 2 and 0.1% only from 16. Twice-weekly maintenance is licensed for people with four or more flares a year, which is the EU basis for TCI Weekend Therapy. The flare trials included 1,535 patients aged 2–16. In the maintenance trials (250 aged 2–15), moderate-to-severe patients had on average about one flare a year on Protopic against three on placebo (EMA Protopic EPAR).
• Dupilumab (Dupixent) is licensed in children aged 6 months–11 years for severe AD only (EMA EPAR). The EMA page does not give the date of the 6-month extension.
• Oral baricitinib (JAK Inhibitors) is licensed for moderate-to-severe AD from age 2, as an oral suspension or dissolved tablets, when topical treatment is not enough (Olumiant EPAR). Abrocitinib and upadacitinib are licensed from age 12.
• Ruxolitinib Cream (Opzelura) is licensed for moderate AD in adults only. Delgocitinib cream (Anzupgo) is licensed only for chronic hand eczema in adults.
• The EU licence for Crisaborole (Staquis), from age 2, was withdrawn on 31 January 2022 at Pfizer’s request “for commercial reasons”, before the product was ever marketed. Pfizer had already dropped the remaining EU PIP studies.

European Medicines Agency [regulates] Tacrolimus European Medicines Agency [regulates] Ruxolitinib Cream European Medicines Agency [regulates] Crisaborole

Differences from the FDA logged in this vault. The EMA and the FDA assess largely the same trial data but often reach different paediatric labels:

The direction varies. The US is broader for dupilumab, crisaborole and ruxolitinib, and the EU is broader for baricitinib. None of these splits reflects a new safety signal. They come from differences in what companies filed and how severity thresholds were set. For a toddler, the practical effect is that a cream or injection offered in one country may be off-label or unavailable in another.

Conflict: [EMA Dupixent EPAR] licenses dupilumab for severe AD only in 6 months–11 years. [FDA Dupixent label, 2026] licenses it for moderate-to-severe AD from 6 months. Already logged in Dupilumab — unresolved; see open_questions.

European Medicines Agency [contradicts] FDA

Herbal and excipient safety. The EMA’s Committee on Herbal Medicinal Products (HMPC) issued a 2005 public statement on Aristolochic Acid. It reported over 40% of UK Fang ji and Mu Tong samples containing aristolochic acids, after UK patients taking Chinese Herbal Medicine for eczema developed kidney failure. Its excipient labelling guideline (2003, annex updated 2019) requires any medicine containing Arachis Oil to be contraindicated in peanut or soya allergy (Peanut Oil Sensitisation). Both are relevant to Track A remedies and to emollients used on toddlers.

Unregulated herbal creams

Traditional Chinese remedies and “natural” creams bought outside licensed channels have contained nephrotoxic aristolochic acids or undeclared steroids. EU herbal registration does not cover products imported or sold online without authorisation.

European Medicines Agency [regulates] Aristolochic Acid European Medicines Agency [regulates] Arachis Oil

Licensing update (Oct 2026). The EMA medicines register was checked on 3 October 2026. Roflumilast cream and Tapinarof Cream have no EU authorisation (roflumilast is listed only as Daxas tablets for COPD). Opzelura (Ruxolitinib Cream) is still licensed for AD in adults only. Dupilumab is still licensed for severe AD only in 6 months–11 years. Adtralza (tralokinumab), Ebglyss (lebrikizumab, at least 40 kg) and Nemluvio (nemolizumab) are licensed from 12 years. So EU families of 1–4-year-olds have no access to the newer US-licensed non-steroid creams (Roflumilast Cream, tapinarof, paediatric ruxolitinib). This widens the EU–US gap described above.

European Medicines Agency [relates] Roflumilast Cream European Medicines Agency [relates] Tapinarof Cream

Connections

• Dupilumab — regulates; severe-only 6 mo–11 y, source: EMA EPAR
• JAK Inhibitors — regulates; baricitinib ≥2 y, source: EMA Olumiant EPAR
• Crisaborole — licence withdrawn 2022, source: EMA Staquis
• Ruxolitinib Cream — adults-only AD licence, source: EMA Opzelura EPAR
• Aristolochic Acid — 2005 HMPC public statement on Aristolochia risks, source: EMA 2005
• Tacrolimus — Protopic 0.03% from 2 y, EU-wide since 2002, source: EMA Protopic EPAR
• Weekend Therapy — twice-weekly Protopic maintenance licensed for ≥4 flares/yr, source: EMA Protopic EPAR
• Topical Calcineurin Inhibitors — no EU boxed warning (contrast FDA), source: vault synthesis
• FDA — counterpart; paediatric label differences, source: EPARs vs FDA labels
• MHRA — separate UK licensing after Brexit, source: vault synthesis
• Arachis Oil — excipient guideline contraindication in peanut/soya allergy, source: EMA excipient annex 2019
• Peanut Oil Sensitisation — excipient labelling rule, source: Pharmaceutical Journal 2021
• Chinese Herbal Medicine — HMPC aristolochia statement, source: EMA 2005
• Roflumilast Cream — no EU authorisation for the cream, source: EMA medicines report 2026-10-03
• Tapinarof Cream — no EU authorisation, source: EMA medicines report 2026-10-03