This document is an excerpt from the EUR-Lex website
Document 52025XC01150
Communication from the Commission – Indicative list of hazardous medicinal products according to Article 18a of Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work
Communication from the Commission – Indicative list of hazardous medicinal products according to Article 18a of Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work
Communication from the Commission – Indicative list of hazardous medicinal products according to Article 18a of Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work
C/2025/909
OJ C, C/2025/1150, 20.2.2025, ELI: http://data.europa.eu/eli/C/2025/1150/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
Official Journal |
EN C series |
|
C/2025/1150 |
20.2.2025 |
COMMUNICATION FROM THE COMMISSION
Indicative list of hazardous medicinal products according to Article 18a of Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work
(C/2025/1150)
1. INTRODUCTION
1.1. Hazardous medicinal products (HMPs) and legal context of the project
Hazardous medicinal products (HMPs) include, amongst others, some antineoplastics, immunosuppressants and antiviral medicines and are used to treat a wide range of medical conditions including cancer and rheumatology. HMPs can cause unintended effects in people other than the patients themselves, such as the workers who are exposed to them at the workplace.
The Carcinogens, Mutagens and Reprotoxic Substances Directive 2004/37/EC (1) (CMRD) is the main EU legislative tool to ensure workers’ protection against risks arising from the exposure to carcinogens, mutagens and reprotoxic substances at the place of work and HMPs, due to their effect mechanism on the body, often fall under these categories.
The European Parliament, the Council and relevant stakeholders support the Commission’s commitment to continuously update the CMRD and as part of its fourth amendment (2), the Commission was invited by the co-legislators, in article 18a, to establish a definition and indicative list of HMPs: ‘Where appropriate and no later than 5 April 2025, taking into account the latest developments in scientific knowledge and after appropriate consultation of relevant stakeholders, the Commission shall develop a definition and establish an indicative list of hazardous medicinal products or the substances contained therein, which meet the criteria for classification as a category 1A or 1B carcinogen set out in Annex I to Regulation (EC) No 1272/2008, a mutagen or a reprotoxic substance.’
1.2. Benefits of an indicative HMPs list
It has to be noted, that the main purpose of this list is to further improve the safety of workers due to exposure to HMPs and not to replace HMPs with medicines that are not hazardous or are less hazardous to workers’ health. Indeed, this is rarely an option because the intrinsic properties of the HMPs are usually essential for the patient’s treatment and their health should not be compromised.
The more detailed information about HMPs provided by this document aims at improving the quality of the risk assessment according to Directive 89/391/EEC (3) and CMRD, thus helping protecting workers in a better way. It has to be noted, that this list cannot replace the mandatory chemical risk assessment of the specific workplace which might take into account other available information such as the concentration of a specific substance or of several substances within the medicinal products. Therefore, the document can only be seen as an indicative, non-binding and complementary element to the above-mentioned risk assessment.
At the same time the indicative list complements the technical information of the Guidance (4) published by the Commission in April 2023 and can be seen as another element of awareness raising about the risks linked to working with HMPs.
Furthermore, the indicative HMPs list presents an approach at EU level which does not yet exist and thus helps promoting a more aligned approach between Member States.
1.3. Existing hazardous medicinal products lists and systems
Other than the list presented in this document, the employer can consult the sources presented in Table 2-1 of the Guidance (5) showing different lists and information systems established by several countries.
At international level, additional information can be found in the 2020 list proposed by the National Institute for Occupational Safety and Health (NIOSH (6)) and in the list prepared by the European Trade Union Institute in 2022 (7) whose basis is the abovementioned list.
The NIOSH (8) list creates no legal obligation for employers; it is advisory in nature and informational in content. The methodology used by NIOSH to evaluate chemical properties, pre-clinical information, and clinical information about each drug has made it a recognised source of information in expert circles.
2. DEFINITION OF HMPs
For the purposes of this document, hazardous medicinal products (9) are defined (10) as medicinal products that contain one or more substances that meet the criteria for classification as:
|
— |
Carcinogenic (category 1A or 1B) |
|
— |
Mutagenic (category 1A or 1B) or |
|
— |
Toxic for reproduction (category 1A or 1B) |
in accordance with Regulation (EC) No 1272/2008 (CLP Regulation) (11).
In addition, medicinal products are defined as follows in accordance with Directive 2001/83/EC (12):
‘ Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or
to making a medical diagnosis. ’
3. METHODOLOGICAL APPROACH FOR THE ESTABLISHMENT OF AN INDICATIVE HMPs LIST
3.1. Drafting Group and involvement of relevant stakeholders
The process of developing this document was supported by a Drafting Group including representatives from governments, employers and workers interest groups of the tripartite Advisory Committee for Safety and Health at Work (ACSH) Working Party on Chemicals (WPC). The Drafting Group was led by representatives of the Directorate-General for Employment, Social Affairs and Inclusion and was also composed of experts from the European Medicines Agency (EMA) and the European Chemicals Agency (ECHA).
The document was endorsed by the WPC and the ACSH.
3.2. Establishment of an indicative HMPs list
Following the definition of HMPs mentioned above, the Drafting Group has decided to establish the indicative HMPs list by crossing the information from existing databases of two European Agencies (13):
|
— |
the ECHA database on hazardous substances |
|
— |
the EMA database on medicinal products |
3.2.1. ECHA database on hazardous substances
The data provided by ECHA for this document originated from the information sources presented below.
3.2.1.1. Harmonised classification information
The available information on harmonised classifications for hazardous substances originated from the Annex VI of CLP and of the Registry of Intentions (RoI).
Annex VI of CLP
The official and legally binding harmonised classification and labelling of hazardous substances, including Carcinogenic, Mutagenic and Reprotoxic (CMR) substances, is available from Part 3 of Annex VI to CLP which is regularly updated by the subsequent delegated acts (14) published in the Official Journal of the European Union.
Registry of classification and labelling intentions until outcome (RoI)
The RoI lists the intentions and proposals received by ECHA for a new or revised harmonised classification and labelling of a substance. It informs on the progress of a proposal from the notification of the intention to the adoption of the opinion of the Committee for Risk Assessment (RAC). It therefore lists, amongst others, substances which are not yet listed in Annex VI of CLP.
3.2.1.2. Self-classification information
Under the CLP regulation, manufacturers, importers and downstream users have the obligation to review whether a substance must be self-classified (and notified), if it presents hazardous properties, and has no harmonised classification (Annex VI to CLP) (15). To decide on a self-classification, the manufacturer, importer or downstream user must gather all the available information, assess its adequacy and reliability and evaluate it against the classification criteria.
All relevant hazard classes (such as carcinogen, mutagen or toxic to reproduction) must be assessed by the manufacturer, importer or downstream user and a self-classification must be applied to all hazard classes for which the classification criteria are fulfilled. Furthermore, all the hazard classes that are not covered by an entry in Annex VI to CLP must be assessed for self-classification.
Self-classifications are submitted to ECHA, either via a REACH registration (16) or a classification and labelling (C&L) notification (17) (both types can be found in the C&L inventory (18)). It must furthermore be noted that:
|
— |
self-classifications submitted to ECHA, either via REACH registration or C&L notification, may vary between the different parties submitting the notifications. |
This results from the absence of obligation on the EU actors to find an agreement amongst themselves concerning the self-classification:
|
— |
a self-classification submitted to ECHA, via REACH registration, is generally supported by a dossier containing data and prepared by registrants; |
|
— |
a self-classification submitted to ECHA, via C&L notification, is not generally supported by a REACH registration dossier (19); |
|
— |
the quality and reliability of the data used for self-classification is generally not assessed by ECHA. |
For the purpose of this list, the available information on substances’ CMR properties given through self-classifications originated from either a REACH registration or from the C&L inventory notifications.
As per the above, the reliability of data linked to self-classifications is considered to vary compared to that of harmonised classification. In case of uncertainty, with regard to the self-classification of a particular substance, it is recommended that the employer contacts the company in charge of the release of the given HMP on the market to obtain additional information (Material Safety Data Sheet or similar document) concerning the classification of the substance.
3.2.2. EMA database on medicinal products
EMA publishes in its Article 57 (20) database information on all medicines authorised in the EU and European Economic Area (EEA). Marketing authorisation holders must submit and maintain this information in accordance with the European Union legislation.
3.2.3. Linking of ECHA and EMA databases and structure of the indicative HMPs list
All ECHA data sources include substances which can potentially serve as an active medicinal product ingredient in HMPs. The ECHA database has therefore been filtered by CMR substances category 1A and 1B and crossed with the EMA data. As a result, a list with HMPs containing substances having a harmonised classification / self-classified classification in accordance with Regulation (EC) No 1272/2008 and being authorised as medicines in the EU and EEA has been established.
Since the NIOSH list is considered as a reputable source, substances fulfilling the definition mentioned under section 2. of this document and being also part of the 2020 NIOSH list are presented separately in Annex 1. In addition, and while avoiding duplication, the harmonised and self-classified substances which are not part of the 2020 NIOSH list are included in Annex 2.
The final indicative HMPs list has 2 annexes and 4 tables corresponding to the different information sources:
|
Annex 1 |
: |
lists HMPs with harmonised or self-classified CMR 1 A/B properties which have been identified by NIOSH (2020) and selected by ETUI (2022) according to their presence on the EU market |
|
Annex 2a |
: |
lists HMPs with harmonised CMR 1A/1B classifications (21) |
|
Annex 2b |
: |
lists HMPs with CMR 1A/1B self-classifications submitted in REACH registrations by lead registrants (EU manufacturers or importers) |
|
Annex 2c |
: |
lists HMPs with CMR 1A/1B self-classifications submitted by notifiers having obligations under CLP |
Figure 1 describes the underlying methodological approach.
The resulting annexes and tables present the information in the following columns:
|
— |
Active medicinal product ingredient (name of the hazardous substance): where applicable, the name of the chemical salt/hydrated form of the substance is indicated in brackets. |
|
— |
EC number (European Community Number- as published in the EU official Journal): where applicable, the EC number corresponds to the relevant form (in brackets). |
|
— |
CAS RN (Chemical Abstracts Service Registry Number): where applicable, the CAS RN corresponds to the relevant form (in brackets). |
|
— |
Therapeutic class (as listed in the Anatomical Therapeutic Chemical (ATC) (22) classification system. |
|
— |
Muta 1A/1B classification: indicates the classification as Mutagen following the definition under the CLP Regulation. |
|
— |
Carc 1A/1B classification: indicates the classification as Carcinogen following the definition shown under the CLP Regulation. |
|
— |
Repr 1A/1B classification: indicates the classification as Reprotoxic following the definition shown under the CLP Regulation. |
|
— |
EU classification (only Annex 1): indicates which EU classification the NIOSH substance bears. |
|
— |
Number of notifiers vs. total (only Annex 2c): indicates how many notifiers have self-classified the substance as CMR 1A/1B and puts it in relation to the total number of notifiers. Note: this data gives an indication about the representativeness of the information among EU actors. |
3.2.4. Principles and limitations of the methodological approach
This methodological approach is based on the following principles:
|
1. |
Consistent with the definition under section 2, any substance with a CMR category 1 A/B (self-)classification was included. |
|
2. |
If a substance has a harmonised classification related only to non-CMR properties; it is acknowledged that the CMR properties may not have been assessed during the Harmonised classification and labelling (CLH) process. However, information may exist that led EU actors to also self-classify the substance as CMR category 1A/1B and therefore these substances are included in Annex 2b or 2c. |
|
3. |
If a substance has a harmonised CMR classification, any additional CMR self-classifications are not duplicated as the harmonised CMR classification prevails. |
|
4. |
In Annex 2a, for reliability reasons, substances with the Note N have been excluded. For substances marked with a Note N in the Annex VI of CLP, the classification of the substance depends on the content and level of some impurities classified as CMR 1A/1B. Considering that the substances used in the production of medicinal products need to respect the high quality standards indicated in the European Pharmacopoeia which leads to very low levels of impurities, the non-CMR classification indicated in the ECHA database, and not the CMR classification due to impurities, should be considered. |
|
5. |
In Annex 2b, only information submitted by lead registrants has been included; this is to increase the reliability of the information provided. |
|
6. |
In Annex 2c, only substances with a ratio of ≥ 50 % of notifiers (submitting self-classification for CMR 1A/B properties) compared to the total number of notifiers have been included; this is to increase the reliability of the information provided. By doing so, 201 substances have been discarded from the original pool of substances. |
|
7. |
To optimize the entries, some HMPs which are other forms of a parent compound, and which have both the same properties and the same therapeutic class (e.g. salts, hydrate forms, conjugated forms) have been removed from the annexes. The parent compound only has been kept in the annexes. This is the case for the following parent compounds: beclomethasone, betamethasone, cobalt (II) chloride, cyclophosphamide, estradiol, etoposide, ganirelix, hydrocortisone, leuprorelin, methotrexate, methylprednisolone, norethisterone, pemetrexed, perindopril, prednisolone, progesterone, retinol, sorafenib, tamoxifen, testosterone, topotecan. Users of the indicative list are advised to check whether other kind of forms (e.g. salts, hydrate forms, conjugated forms) listed in the annexes are relevant to them. |
|
8. |
As medicinal products are excluded from the CLP requirements, they are not systematically evaluated under CLP. Thus, some relevant medicinal products may be missing from this HMP list because of a lack of incentive to self-classify them under the CLP. |
|
9. |
New HMPs are constantly brought to the market, removed from the market or have their authorisation withdrawn. Therefore, this list can only reflect the information available at the date of its creation (June 2024). |
(1) Directive 2004/37/EC of the European Parliament and of the Council on the protection of workers from the risks related to exposure to carcinogens, mutagens, or reprotoxic substances at work (OJ L 158, 30.4.2004, p. 50).
(2) Directive 2022/431 of the European Parliament and of the Council of 9 March 2022 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (OJ L 88, 16.3.2022, p. 1).
(3) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).
(4) Guidance for the safe management of hazardous medicinal products at work, 2023.
(5) Guidance for the safe management of hazardous medicinal products at work, 2023.
(6) US Department of Health and Human Services Centers for Disease Control and Prevention National Institute for Occupational Safety and Health: NIOSH List of Hazardous Drugs in Healthcare Settings, 2020.
(7) European Trade Union Institute’s (ETUI’s) list of hazardous medicinal products (HMPs) including cytotoxics and based on the EU CLP classification system of Carcinogenic, Mutagenic and Reprotoxic (CMR) substances (2022) is available at: https://www.etui.org/publications/etuis-list-hazardous-medicinal-products-hmps.
(8) The NIOSH List of Hazardous Drugs in Healthcare Settings assists employers in providing safe and healthy workplaces by identifying drugs approved by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) that have intrinsic properties that meet the NIOSH definition of a hazardous drug.
(9) As the same HMPs are used for both humans and animals (although less common in the animal health sector), the HMPs covered by the above definition also include those used in the veterinary sector.
(10) Recital 11 of Directive (EU) 2022/431 of the European Parliament and of the Council of 9 March 2022 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (OJ L 88, 16.3.2022, p. 1).
(11) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1).
(12) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(13) The evaluation of the databases was finished in June 2024.
(14) Following the adoption of the opinion on the harmonised classification and labelling of a substance by the Committee for Risk Assessment (RAC) of ECHA, the European Commission takes a decision and
updates the list of harmonised classifications in Annex VI of CLP on a yearly basis by delegated acts.
(15) If the substance has a harmonised classification, manufacturers, importers and downstream users have an obligation to classify the substance in accordance with that harmonised classification for hazard classes covered by it.
(16) Companies are responsible for collecting information on the properties and uses of the substances they manufacture or import above one tonne a year. They also have to assess the hazards and potential risks presented by the substance. This information is communicated to ECHA through a registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled.
(17) Manufacturer or importer in determined cases has to notify a substance to the C&L inventory within one month from being placed on the market.
(18) This database contains classification and labelling information on notified and registered substances received from manufacturers and importers. This also covers substances that are subject to harmonised classification.
(19) In accordance with Article 5 of CLP regulation, manufacturers, importers and downstream users of a substance shall identify all the relevant available information for the purposes of determining whether that substance entails any hazards and examine that data accordingly.
(20) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30/04/2004, p. 1).
(21) Including RoI substances, see paragraph 3.2.1.1.
(22) ATC classification system: the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. It has to be noted that the list includes, in line with the definition mentioned under section 2., also classes like diagnostic agents or nutrients or mineral supplements which do not exhibit direct pharmaceutical effects.
ANNEX 1
HMPs with harmonised or self-classified CMR 1 A/B properties which have been identified by NIOSH (2020) and selected by ETUI (2022) according to their presence on the EU market
|
Active medicinal product ingredient |
EC Number |
CAS RN |
Therapeutic class |
EU (self-) - classification (H, R, N) (1) |
Muta 1A/1B |
Carc 1A/1B |
Repr 1A/1B |
|
Abacavir |
620-487-9 |
136470-78-5 |
Direct acting antivirals |
R |
|
|
X |
|
Acitretin |
259-474-4 |
55079-83-9 |
Antipsoriatics for systemic use |
N |
|
|
X |
|
Alitretinoin / retinoic acid |
610-929-9 |
5300-03-8 |
Other dermatological preparations |
N |
|
|
X |
|
Arsenic trioxide |
215-481-4 |
1327-53-3 |
Other antineoplastic agents |
H |
|
X |
|
|
Axitinib |
638-771-6 |
319460-85-0 |
Protein kinase inhibitors |
N |
|
|
X |
|
Azacitidine |
206-280-2 |
320-67-2 |
Antineoplastic agents |
N |
X |
X |
X |
|
Azathioprine |
207-175-4 |
446-86-6 |
Immunosuppressants |
N |
X |
X |
X |
|
Bendamustine (hydrochloride) |
631-540-0 |
3543-75-7 |
Alkylating agents |
N |
X |
X |
X |
|
Bicalutamide |
618-534-3 |
90357-06-5 |
Hormone antagonists and related agents |
N |
|
|
X |
|
Bleomycin (sulfate) |
232-925-2 |
9041-93-4 |
Cytotoxic antibiotics and related substances |
N |
X |
X |
X |
|
Bortezomib |
605-854-3 |
179324-69-7 |
Other antineoplastic agents |
N |
|
|
X |
|
Bosentan |
643-099-1 |
147536-97-8 |
Antihypertensives |
N |
|
|
X |
|
Busulfan |
200-250-2 |
55-98-1 |
Alkylating agents |
N |
X |
X |
X |
|
Cabazitaxel |
680-632-7 |
183133-96-2 |
Antineoplastic agents |
N |
|
|
X |
|
Cabozantinib (S-malate) |
691-711-0 |
1140909-48-3 |
Antineoplastic agents |
N |
|
|
X |
|
Capecitabine |
604-948-1 |
154361-50-9 |
Antimetabolites |
N |
|
X |
X |
|
Carboplatin |
255-446-0 |
41575-94-4 |
Other antineoplastic agents |
N |
X |
X |
X |
|
Carmustine |
205-838-2 |
154-93-8 |
Alkylating agents |
N |
X |
X |
X |
|
Cetrorelix (acetate) |
685-963-0 |
145672-81-7 |
Pituitary and hypothalamic hormones and analogues |
N |
|
|
X |
|
Chlorambucil |
206-162-0 |
305-03-3 |
Alkylating agents |
N |
X |
X |
X |
|
Chloramphenicol |
200-287-4 |
56-75-7 |
Antibiotics for topical use |
N |
X |
X |
X |
|
Chlormethine (hydrochloride) |
200-246-0 |
55-86-7 |
Antineoplastic agents |
N |
X |
X |
X |
|
Cisplatin |
239-733-8 |
15663-27-1 |
Other antineoplastic agents |
N |
X |
X |
X |
|
Clofarabine |
631-422-9 |
123318-82-1 |
Antimetabolites |
N |
|
|
X |
|
Colchicine |
200-598-5 |
64-86-8 |
Antigout preparations |
R |
X |
|
|
|
Cyclophosphamide |
200-015-4 |
50-18-0 |
Alkylating agents |
N |
X |
X |
X |
|
Cyclosporine |
611-907-1 |
59865-13-3 |
N.A. |
N |
|
X |
X |
|
Cytarabine |
205-705-9 |
147-94-4 |
Antimetabolites |
N |
X |
|
X |
|
Dacarbazine |
224-396-1 |
750512-03-9 |
Alkylating agents |
N |
X |
X |
|
|
Dactinomycin |
200-063-6 |
50-76-0 |
Cytotoxic antibiotics and related substances |
N |
|
X |
X |
|
Dasatinib (hydrate) |
638-874-6 |
863127-77-9 |
Antineoplastic agents |
N |
|
|
X |
|
Daunorubicin (hydrochloride) |
245-723-4 |
23541-50-6 |
Cytotoxic antibiotics and related substances |
N |
X |
X |
X |
|
Decitabine |
219-089-4 |
2353-33-5 |
Antimetabolites |
N |
X |
|
X |
|
Diethylstilbestrol |
200-278-5 |
56-53-1 |
Estrogens |
N |
|
X |
X |
|
Dinoprostone |
206-656-6 |
363-24-6 |
Uterotonics |
N |
|
|
X |
|
Docetaxel |
601-339-2 |
114977-28-5 |
Plant alkaloids and other natural products |
N |
X |
X |
X |
|
Doxorubicin hydrochloride |
246-818-3 |
25316-40-9 |
Cytotoxic antibiotics and related substances |
N |
X |
X |
X |
|
Dutasteride |
638-758-5 |
164656-23-9 |
Urologicals |
N |
|
|
X |
|
Entecavir monohydrate |
606-668-5 |
209216-23-9 |
Antivirals for systemic use |
N |
|
|
X |
|
Enzalutamide |
805-022-1 |
915087-33-1 |
Hormone antagonists and related agents |
N |
|
|
X |
|
Epirubicin hydrochloride |
260-145-2 |
56390-09-1 |
Cytotoxic antibiotics and related substances |
N |
X |
X |
X |
|
Erlotinib (hydrochloride) |
620-491-0 |
183319-69-9 |
Cytotoxic antibiotics and related substances |
N |
|
|
X |
|
Estradiol |
200-023-8 |
50-28-2 |
Estrogens |
N |
|
X |
X |
|
Estramustine (phosphate) |
225-512-3 |
4891-15-0 |
Other antineoplastic agents |
N |
|
|
X |
|
Estrogens conjugated |
235-199-5 |
12126-59-9 |
Estrogens |
N |
|
X |
X |
|
Etoposide |
251-509-1 |
33419-42-0 |
Plant alkaloids and other natural products |
N |
X |
X |
X |
|
Exemestane |
643-090-2 |
107868-30-4 |
Endocrine therapy |
N |
|
|
X |
|
Finasteride |
620-534-3 |
98319-26-7 |
Other dermatological preparations |
N |
|
|
X |
|
Fluconazole |
627-806-0 |
86386-73-4 |
Antifungals for topical use |
N |
|
|
X |
|
Fludarabine (phosphate) |
616-242-0 |
75607-67-9 |
Antineoplastic agents |
N |
|
X |
X |
|
Fluorouracil |
200-085-6 |
51-21-8 |
Antimetabolites |
R |
X |
|
X |
|
Flutamide |
236-341-9 |
13311-84-7 |
Hormone antagonists and related agents |
N |
|
|
X |
|
Fulvestrant |
642-998-6 |
129453-61-8 |
Hormone antagonists and related agents |
N |
|
|
X |
|
Ganciclovir |
627-054-3 |
82410-32-0 |
Direct acting antivirals |
N |
|
|
X |
|
Ganirelix |
689-234-8 |
124904-93-4 |
Hypothalamic hormones |
N |
|
|
X |
|
Gemcitabine |
619-100-6 |
95058-81-4 |
Antimetabolites |
N |
|
|
X |
|
Goserelin |
686-281-6 |
65807-02-5 |
Endocrine therapy |
N |
|
|
X |
|
Hydroxycarbamide |
204-821-7 |
127-07-1 |
Other antineoplastic agents |
N |
X |
|
X |
|
Idarubicin (hydrochloride) |
260-990-7 |
57852-57-0 |
Cytotoxic antibiotics and related substances |
N |
X |
X |
X |
|
Ifosfamide |
223-237-3 |
3778-73-2 |
Alkylating agents |
N |
X |
X |
X |
|
Imatinib |
604-855-6 |
152459-95-5 |
Protein kinase inhibitors |
R |
|
|
X |
|
Irinotecan (hydrochloride) |
603-967-2 |
136572-09-3 |
Plant alkaloids and other natural products |
N |
X |
|
X |
|
Isotretinoin |
225-296-0 |
4759-48-2 |
Anti-acne preparations for topical use |
N |
|
|
X |
|
Ivabradine (hydrochloride) |
638-798-3 |
148849-67-6 |
Cardiac therapy |
N |
|
|
X |
|
Ixazomib (citrate) |
813-102-2 |
1239908-20-3 |
Antineoplastic agents |
N |
|
|
X |
|
Lenalidomide |
691-297-1 |
191732-72-6 |
Immunosuppressants |
N |
|
|
X |
|
Letrozole |
675-034-8 |
112809-51-5 |
Hormone antagonists and related agents |
N |
|
|
X |
|
Leuprorelin |
633-395-9 |
53714-56-0 |
Hormones and related agents |
N |
|
|
X |
|
Lomustine |
235-859-2 |
13010-47-4 |
Alkylating agents |
N |
X |
X |
X |
|
Medroxyprogesterone acetate |
200-757-9 |
71-58-9 |
Hormonal contraceptives for systemic use |
N |
X |
|
X |
|
Megestrol (acetate) |
209-864-5 |
595-33-5 |
Hormonal contraceptives for systemic use |
N |
|
X |
X |
|
Melphalan |
205-726-3 |
148-82-3 |
Alkylating agents |
N |
X |
X |
X |
|
Methotrexate |
200-413-8 |
59-05-2 |
Antimetabolites |
N |
X |
|
X |
|
Methylergometrine (maleate) |
260-734-4 |
57432-61-8 |
Other gynecologicals |
N |
|
|
X |
|
Mifepristone |
617-559-7 |
84371-65-3 |
Other sex hormones and modulators of the genital system |
N |
|
|
X |
|
Misoprostol |
664-288-5 |
59122-46-2 |
Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord) |
N |
|
|
X |
|
Mitomycin |
200-008-6 |
50-07-7 |
Cytotoxic antibiotics and related substances |
N |
X |
X |
X |
|
Mitotane |
200-166-6 |
53-19-0 |
Other antineoplastic agents |
N |
|
|
X |
|
Mitoxantrone (dihydrochloride) |
274-619-1 |
70476-82-3 |
Cytotoxic antibiotics and related substances |
N |
X |
X |
X |
|
Mycophenolate mofetil |
627-027-6 |
128794-94-5 |
Immunosuppressants |
N |
|
|
X |
|
Mycophenolic acid |
246-119-3 |
24280-93-1 |
Immunosuppressants |
R |
|
|
X |
|
Nelarabine |
642-916-9 |
121032-29-9 |
Antimetabolites |
N |
|
|
X |
|
Nilotinib |
700-544-5 |
641571-10-0 |
Antineoplastic agents |
N |
|
|
X |
|
Olaparib |
642-941-5 |
763113-22-0 |
Other antineoplastic agents |
N |
|
|
X |
|
Oxaliplatin |
621-248-1 |
61825-94-3 |
Other antineoplastic agents |
N |
X |
X |
X |
|
Paclitaxel |
608-826-9 |
33069-62-4 |
Plant alkaloids and other natural products |
N |
|
X |
X |
|
Panobinostat |
803-814-1 |
404950-80-7 |
Other antineoplastic agents |
N |
|
|
X |
|
Pazopanib (hydrochloride) |
619-728-0 |
635702-64-6 |
Antineoplastic agents |
N |
|
|
X |
|
Pemetrexed |
680-625-9 |
137281-23-3 |
Antimetabolites |
N |
|
|
X |
|
Phenytoin |
200-328-6 |
57-41-0 |
Antiepileptics |
R |
|
|
X |
|
Pomalidomide |
805-902-5 |
19171-19-8 |
Immunosuppressants |
N |
|
|
X |
|
Procarbazine (hydrochloride) |
206-678-6 |
366-70-1 |
Other antineoplastic agents |
N |
X |
X |
X |
|
Progesterone |
200-350-6 |
57-83-0 |
Progestogens |
N |
X |
X |
X |
|
Raloxifene (hydrochloride) |
639-789-7 |
82640-04-8 |
Other sex hormones and modulators of the genital system |
N |
|
|
X |
|
Regorafenib |
815-051-1 |
755037-03-7 |
Protein kinase inhibitors |
N |
|
|
X |
|
Ribavirin |
636-825-3 |
36791-04-5 |
Direct acting antivirals |
N |
|
|
X |
|
Sorafenib |
608-209-4 |
284461-73-0 |
Protein kinase inhibitors |
N |
|
|
X |
|
Spironolactone |
200-133-6 |
52-01-7 |
Aldosterone antagonists and other potassium-sparing agents |
N |
|
|
X |
|
Streptozocin |
242-646-8 |
18883-66-4 |
Alkylating agents |
N |
X |
X |
X |
|
Sunitinib (malate) |
638-825-9 |
341031-54-7 |
Antineoplastic agents |
N |
|
|
X |
|
Tamoxifen |
234-118-0 |
10540-29-1 |
Hormone antagonists and related agents |
R |
|
X |
X |
|
Temozolomide |
630-358-9 |
85622-93-1 |
Alkylating agents |
N |
X |
|
X |
|
Temsirolimus |
686-177-0 |
162635-04-3 |
Protein kinase inhibitors |
N |
|
|
X |
|
Testosterone |
200-370-5 |
58-22-0 |
Androgens |
R |
|
|
X |
|
Thalidomide |
200-031-1 |
50-35-1 |
Immunosuppressants |
N |
|
|
X |
|
Thiotepa |
200-135-7 |
52-24-4 |
Alkylating agents |
N |
X |
X |
X |
|
Tioguanine |
205-827-2 |
154-42-7 |
Antimetabolites |
N |
X |
X |
X |
|
Tofacitinib |
689-145-4 |
477600-75-2 |
Immunosuppressants |
N |
|
|
X |
|
Topotecan |
687-471-1 |
123948-87-8 |
Antineoplastic agents |
N |
X |
|
|
|
Trametinib |
629-899-3 |
871700-17-3 |
Protein kinase inhibitors |
N |
|
|
X |
|
Trastuzumab emtansine |
854-470-4 |
1018448-65-1 |
Monoclonal antibodies and antibody drug conjugates |
N |
X |
|
X |
|
Treosulfan |
206-081-0 |
299-75-2 |
Antineoplastic agents |
N |
|
X |
|
|
Tretinoin |
206-129-0 |
302-79-4 |
Anti-acne preparations for topical use |
N |
|
|
X |
|
Triptorelin (palmoate) |
689-181-0 |
124508-66-3 |
Endocrine therapy |
N |
|
|
X |
|
Ulipristal (acetate) |
682-170-1 |
126784-99-4 |
Sex hormones and modulators of the genital system |
N |
|
|
X |
|
Urofollitropin |
686-287-9 |
146479-72-3 |
Sex hormones and modulators of the genital system |
N |
|
|
X |
|
Valganciclovir (hydrochloride) |
641-360-4 |
175865-59-5 |
Antivirals for systemic use |
N |
X |
X |
X |
|
Valproate semisodium / Sodium valproate / Valproic acid |
630-325-9 / 213-961-8 / 202-777-3 |
76584-70-8 / 1069-66-5 / 99-66-1 |
Antiepileptics |
N / N / R |
|
|
X |
|
Vandetanib |
669-841-4 |
443913-73-3 |
Protein kinase inhibitors |
N |
|
|
X |
|
Vinorelbine (tartrate) |
639-264-2 |
125317-39-7 |
Plant alkaloids and other natural products |
N |
X |
X |
X |
|
Voriconazole |
629-701-5 |
137234-62-9 |
Antimycotics for systemic use |
N |
|
|
X |
|
Warfarin (sodium) |
204-929-4 |
129-06-6 |
Antithrombotic agents |
N |
|
|
X |
|
Zidovudine |
623-849-4 |
30516-87-1 |
Antivirals for systemic use |
N |
|
X |
|
(1) H=Harmonised, R=Registration, N=Notification.
ANNEX 2a
HMPs with harmonised CMR 1A/1B classifications
|
Active medicinal product ingredient |
EC Number |
CAS RN |
Therapeutic class |
Muta 1A/1B |
Carc 1A/1B |
Repr 1A/1B |
|
4,4′-Methylenedianiline |
202-974-4 |
101-77-9 |
Other diagnostic agents |
|
X |
|
|
Borax |
215-540-4 |
1303-96-4 |
stomatological preparations |
|
|
X |
|
Boric acid |
233-139-2 |
10043-35-3 |
Antiinfectives |
|
|
X |
|
Carbon monoxide |
211-128-3 |
630-08-0 |
Other diagnostic agents |
|
|
X |
|
Coal tar |
232-361-7 |
8007-45-2 |
Antipsoriatics for topical use |
|
X |
|
|
Cobalt |
231-158-0 |
7440-48-4 |
Other nutrients |
|
X |
X |
|
Cobalt(II) chloride |
231-589-4 |
7646-79-9 |
Other diagnostic agents |
|
X |
X |
|
Creosote |
232-287-5 |
8001-58-9 |
Expectorants, excl. combinations with cough suppressants |
|
X |
X (Notification) |
|
Formaldehyde |
200-001-8 |
50-00-0 |
Other diagnostic agents |
|
X |
|
|
Hydrazine sulfate |
233-110-4 |
10034-93-2 |
Other diagnostic agents |
|
X (RoI) |
|
|
Kalium bichromicum |
231-906-6 |
7778-50-9 |
Other diagnostic agents |
X |
X |
X |
|
Ketoconazole |
265-667-4 |
65277-42-1 |
Antifungals for topical use |
|
|
X |
|
Methylrosanilinium chloride |
208-953-6 |
548-62-9 |
Antiseptics and disinfectants |
|
X |
|
|
Nickel gluconate |
276-205-6 |
71957-07-8 |
Other mineral supplements |
|
X |
X |
|
Nickel sulfate |
232-104-9 |
7786-81-4 |
Other diagnostic agents |
|
X |
X |
|
Oxyquinoline |
205-711-1 |
148-24-3 |
Stomatological preparations |
|
|
X |
|
Pentetic acid |
200-652-8 |
67-43-6 |
Renal system |
|
|
X |
|
Phenolphthalein |
201-004-7 |
77-09-8 |
Drugs for constipation |
|
X |
|
|
Pyrithione zinc |
236-671-3 |
13463-41-7 |
Other dermatological preparations |
|
|
X |
|
Sodium borate |
215-540-4 |
1330-43-4 |
Antiinfectives |
|
|
X |
|
Sodium perborate |
239-172-9 |
7632-04-4 |
Stomatological preparations |
|
|
X |
|
Theophylline |
200-385-7 |
58-55-9 |
Other systemic drugs for obstructive airway diseases |
|
|
X |
ANNEX 2b
HMPs with CMR 1A/1B self-classifications submitted in REACH registrations by lead registrants (EU manufacturers or importers)
|
Active medicinal product ingredient |
EC number |
CAS RN |
ATC Level 3 |
Muta 1A/1B |
Carc 1A/1B |
Repr 1A/1B |
|
Benzaldehyde |
202-860-4 |
100-52-7 |
Other diagnostic agents |
|
|
X |
|
Betamethasone |
206-825-4 |
378-44-9 |
Intestinal antiinflammatory agents |
|
|
X |
|
Clindamycin hydrochloride |
244-398-6 |
21462-39-5 |
Anti-acne preparations for topical use |
|
|
X |
|
Copper sulfate |
231-847-6 |
7758-98-7 |
All other therapeutic products |
|
X |
X |
|
Dapsone |
201-248-4 |
80-08-0 |
Anti-acne preparations for topical use |
|
|
X |
|
Dimethyl-4-toluidine |
202-805-4 |
99-97-8 |
Other diagnostic agents |
|
X |
|
|
Ethyl chloride |
200-830-5 |
75-00-3 |
Anesthetics, local |
|
|
X |
|
Hydrocortisone |
200-020-1 |
50-23-7 |
Stomatological preparations |
|
|
X |
|
Methylene-bis(methyloxazolidine) |
266-235-8 |
66204-44-2 |
Other diagnostic agents |
|
X |
|
|
Methylprednisolone |
201-476-4 |
83-43-2 |
Corticosteroids, plain |
|
|
X |
|
Metronidazole |
207-136-1 |
443-48-1 |
Stomatological preparations |
|
X |
|
|
Norethisterone |
200-681-6 |
68-22-4 |
Hormonal contraceptives for systemic use |
|
|
X |
|
Nutmeg |
282-013-3 |
84082-68-8 |
Other diagnostic agents |
|
X |
|
|
Prasterone |
200-175-5 |
53-43-0 |
Anabolic steroids |
|
|
X |
|
Prednisolone |
200-021-7 |
50-24-8 |
Stomatological preparations |
|
|
X |
|
Retinol |
200-683-7 |
68-26-8 |
Anti-acne preparations for topical use |
|
|
X |
|
Retinyl acetate |
204-844-2 |
127-47-9 |
Vitamin A and D, incl. combinations of the two |
|
|
X |
|
Shale oil |
269-646-0 |
68308-34-9 |
Antiseptics and disinfectants |
X |
X |
X |
|
Silver nitrate |
231-853-9 |
7761-88-8 |
Antiseptics and disinfectants |
|
|
X |
ANNEX 2c
HMPs with CMR 1A/1B self-classifications submitted by notifiers having obligations under CLP
As explained above, the reliability of data linked to self-classifications is considered to be lower compared to that from the harmonised classification. Therefore, in case of uncertainty, it is recommended that the employer contacts the company in charge of the release of the given HMP on the market, to obtain additional information (Material Safety Data Sheet or similar document) concerning the classification of the substance.
A column indicates how many notifiers have self-classified the substance as CMR 1A/1B and puts it in relation to the total number of notifiers. This data gives an indication about the representativeness and reliability of the information. In annex 2c, for reliability reasons, only substances with a ratio of ≥ 50 % of notifiers indicating CMR 1A/B characteristics compared to the total number of notifiers have been included.
|
Active medicinal product ingredient |
EC number |
CAS RN |
Therapeutic class |
Muta 1A/1B |
Carc 1A/1B |
Repr 1A/1B |
#notifiers (vs total) (ECHA C&L inventory) |
|
Acenocoumarol |
205-807-3 |
152-72-7 |
Antithrombotic agents |
|
|
X |
6 (9) |
|
Acetohydroxamic acid |
208-913-8 |
546-88-3 |
Urologicals |
|
|
X |
7 (10) |
|
Amikacin |
253-538-5 |
37517-28-5 |
Antibiotics for topical use |
|
|
X |
1 (2) |
|
Anagrelide |
864-866-9 |
68475-42-3 |
Other antineoplastic agents |
|
|
X |
1 (1) |
|
Anastrozole |
601-715-6 |
120511-73-1 |
Hormone antagonists and related agents |
|
|
X |
12 (17) |
|
Apalutamide |
807-449-9 |
956104-40-8 |
Hormone antagonists and related agents |
|
X |
|
2 (4) |
|
Baricitinib |
691-421-4 |
1187594-09-7 |
Immunosuppressants |
|
|
X |
3 (5) |
|
Bazedoxifene |
805-732-1 |
198481-32-2 |
Other sex hormones and modulators of the genital system |
|
|
X |
1 (1) |
|
Beclometasone dipropionate |
226-886-0 |
5534-09-8 |
Intestinal antiinflammatory agents |
|
|
X |
12 (22) |
|
Botulinum toxin type E |
297-258-1 |
93384-47-5 |
Muscle relaxants, peripherally acting agents |
|
|
X |
1 (2) |
|
Buserelin acetate |
636-185-5 |
68630-75-1 |
Hormones and related agents |
|
|
X |
6 (7) |
|
Chlormadinone acetate |
206-118-0 |
302-22-7 |
Progestogens |
|
|
X |
7 (9) |
|
Cimetidine |
257-232-2 |
51481-61-9 |
Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord) |
|
|
X |
8 (16) |
|
Clobetasol propionate |
246-634-3 |
25122-46-7 |
Corticosteroids, plain |
|
|
X |
12 (22) |
|
Clomifene citrate |
200-035-3 |
50-41-9 |
Gonadotropins and other ovulation stimulants |
|
|
X |
6 (12) |
|
Corifollitropin alfa |
692-844-7 |
195962-23-3 |
Gonadotropins and other ovulation stimulants |
|
|
X |
2 (2) |
|
Cyproterone |
690-915-7 |
2098-66-0 |
Antiandrogens |
|
|
X |
1 (1) |
|
Danazol |
241-270-1 |
17230-88-5 |
Other sex hormones and modulators of the genital system |
|
|
X |
4 (8) |
|
Desflurane |
688-023-8 |
57041-67-5 |
Anesthetics, general |
|
|
X |
2 (4) |
|
Desogestrel |
258-929-4 |
54024-22-5 |
Hormonal contraceptives for systemic use |
|
|
X |
8 (11) |
|
Dexmedetomidine |
601-281-8 |
113775-47-6 |
Hypnotics and sedatives |
|
|
X |
1 (1) |
|
Diflucortolone valerate |
261-655-8 |
59198-70-8 |
Corticosteroids, plain |
|
|
X |
3 (6) |
|
Dronedarone |
604-240-2 |
141626-36-0 |
Antiarrhythmics, class i and iii |
|
|
X |
2 (4) |
|
Drospirenone |
266-679-2 |
67392-87-4 |
Hormonal contraceptives for systemic use |
|
|
X |
10 (15) |
|
Duvelisib |
813-697-9 |
1201438-56-3 |
Protein kinase inhibitors |
|
|
X |
1 (1) |
|
Efavirenz |
620-492-6 |
154598-52-4 |
Direct acting antivirals |
|
|
X |
9 (17) |
|
Encorafenib |
815-119-0 |
1269440-17-6 |
Protein kinase inhibitors |
|
|
X |
1 (2) |
|
Estetrol |
840-340-4 |
15183-37-6 |
Other dermatological preparations |
|
|
X |
3 (4) |
|
Estriol |
200-022-2 |
50-27-1 |
Estrogens |
|
X |
X |
3 (9) - 7 (9) |
|
Ethambutol dihydrochloride |
213-970-7 |
1070-11-7 |
Drugs for treatment of tuberculosis |
|
|
X |
5 (7) |
|
Etonogestrel |
258-936-2 |
54048-10-1 |
Hormonal contraceptives for systemic use |
|
|
X |
10 (10) |
|
Flecainide acetate |
258-997-5 |
54143-56-5 |
Antiarrhythmics, class i and iii |
|
|
X |
7 (9) |
|
Fluocortolone caproate |
206-140-0 |
303-40-2 |
Agents for treatment of hemorrhoids and anal fissures for topical use |
|
|
X |
1 (2) |
|
Fluocortolone pivalate |
249-504-4 |
29205-06-9 |
Agents for treatment of hemorrhoids and anal fissures for topical use |
|
|
X |
1 (2) |
|
Fluticasone furoate |
629-894-6 |
397864-44-7 |
Decongestants and other nasal preparations for topical use |
|
|
X |
7 (12) |
|
Fotemustine |
630-468-7 |
92118-27-9 |
Alkylating agents |
X |
X |
X |
1 (2) - 1 (2) - 1 (2) |
|
Furosemide |
200-203-6 |
54-31-9 |
High-ceiling diuretics |
|
X |
X |
1 (50) - 28 (50) |
|
Gentamicin |
215-765-8 |
1403-66-3 |
Antibiotics for topical use |
|
|
X |
4 (6) |
|
Griseofulvin |
204-767-4 |
126-07-8 |
Antifungals for topical use |
X |
X |
X |
3 (20) - 1 (20) - 16 (20) |
|
Hydroxyzine |
200-693-1 |
68-88-2 |
Anxiolytics |
|
|
X |
1 (1) |
|
Interferon beta-1B |
682-322-7 |
145155-23-3 |
Antiinfectives |
|
|
X |
2 (2) |
|
Iron(III)-hydroxide dextran complex |
618-390-1 |
9004-66-4 |
Iron preparations |
|
X |
|
3 (4) |
|
Kanamycin sulfate |
246-933-9 |
25389-94-0 |
Intestinal antiinfectives |
|
|
X |
23 (28) |
|
Levonorgestrel |
212-349-8 |
797-63-7 |
Hormonal contraceptives for systemic use |
|
|
X |
8 (12) |
|
Lisinopril |
278-488-1 |
76547-98-3 |
ACE inhibitors, plain |
|
|
X |
4 (7) |
|
Lormetazepam |
212-700-5 |
848-75-9 |
Hypnotics and sedatives |
|
|
X |
2 (3) |
|
Luteinising hormone |
232-661-8 |
9002-67-9 |
Gonadotropins and other ovulation stimulants |
|
|
X |
2 (2) |
|
Lynestrenol |
200-151-4 |
52-76-6 |
Hormonal contraceptives for systemic use |
X |
|
X |
1(3) - 2 (3) |
|
Metenolone enantate |
206-141-6 |
303-42-4 |
Anabolic steroids |
|
|
X |
1 (1) |
|
Methylprednisolone aceponate |
658-084-5 |
86401-95-8 |
Corticosteroids, plain |
|
|
X |
4 (5) |
|
Mycophenolate sodium |
687-703-1 |
37415-62-6 |
Immunosuppressants |
|
|
X |
2 (3) |
|
Nandrolone decanoate |
206-639-3 |
360-70-3 |
Anabolic steroids |
|
|
X |
6 (10) |
|
Netilmicin sulfate |
260-147-3 |
56391-57-2 |
Aminoglycoside antibacterials |
|
|
X |
7 (9) |
|
Nilutamide |
624-700-6 |
63612-50-0 |
Hormone antagonists and related agents |
|
|
X |
3 (4) |
|
Niraparib tosilate monohydrate |
855-068-1 |
1613220-15-7 |
Other antineoplastic agents |
X |
|
X |
2 (3) - 1 (3) |
|
Nomegestrol acetate |
261-379-8 |
58652-20-3 |
Progestogens |
|
|
X |
6 (12) |
|
Perindopril |
617-394-0 |
82834-16-0 |
ACE inhibitors, plain |
|
|
X |
1 (1) |
|
Phenazepam |
682-231-2 |
51753-57-2 |
Anxiolytics |
X |
|
X |
2 (4) - 2 (4) |
|
Phenobarbital |
200-007-0 |
50-06-6 |
Antiepileptics |
|
|
X |
19 (25) |
|
Pirtobrutinib |
864-730-9 |
2101700-15-4 |
Protein kinase inhibitors |
|
|
X |
4 (4) |
|
Podophyllum resin |
232-546-2 |
9000-55-9 |
Drugs for constipation |
|
|
X |
8 (8) |
|
Rosuvastatin |
689-191-5 |
287714-41-4 |
Lipid modifying agents, plain |
|
|
X |
1 (1) |
|
Sacituzumab govitecan |
872-125-6 |
1491917-83-9 |
Monoclonal antibodies and antibody drug conjugates |
|
|
X |
1 (1) |
|
Selpercatinib |
843-660-2 |
2152628-33-4 |
Protein kinase inhibitors |
|
|
X |
3 (3) |
|
Sodium perborate |
239-172-9 |
7632-04-4 |
Stomatological preparations |
|
|
X |
5 (5) |
|
Sulprostone |
262-173-0 |
60325-46-4 |
Uterotonics |
|
|
X |
4 (4) |
|
Talazoparib |
815-271-8 |
1207456-01-6 |
Other antineoplastic agents |
|
|
X |
1 (1) |
|
Tegafur |
241-846-2 |
17902-23-7 |
Antimetabolites |
|
|
X |
2 (4) |
|
Timolol |
248-032-6 |
26839-75-8 |
Beta blocking agents |
|
|
X |
1 (1) |
|
Triamcinolone acetonide |
200-948-7 |
76-25-5 |
Stomatological preparations |
|
|
X |
10 (17) |
|
TriamcinoDlone acetonide dipotassium phosphate |
217-537-3 |
1881-20-5 |
Stomatological preparations |
|
|
X |
1 (1) |
|
Trofosfamide |
244-770-8 |
22089-22-1 |
Alkylating agents |
X |
X |
X |
1 (1) - 1 (1) - 1 (1) |
ELI: http://data.europa.eu/eli/C/2025/1150/oj
ISSN 1977-091X (electronic edition)