Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

THIRD SECTION GENERAL HEALTH COUNCIL DECISION that determines the type of test to demonstrate the interchangeability of generic drug products and that defines the criteria that are applicable to them. At the margin a seal with the United Mexican States Coat of Arms, which says: United Mexican States.- General Health Council. JESUS ANCER RODRIGUEZ, Secretary of the General Health Council and JULIO SALVADOR SANCHEZ Y TEPOZ, Federal Commissioner for the Protection Against Sanitary Risks, pursuant to articles 3 section XXII, 13 paragraph A section II, 15, 17 sections IV and IX, 17 bis sections II, IV and XIII, 17 bis 2, 368 and 376 of the General Health Act; 2, section XIV, 72, 73, 167, section V and 190 bis 1, section III of the Health Supplies Regulation; 1, 9 sections II and IV of the General Health Council Internal Regulations; 1 and 3 section I, subsection b, 5 and 10 sections IV, VIII, X, XV and XXV of the Federal Commission for the Protection Against Sanitary Risks Regulations, and WHEREAS That, in accordance with article 73 of the Health Supplies Regulation, the General Health Council and the Ministry, through publication in the Federal Official Gazette, will determine the interchangeability tests that must be conducted according to the corresponding regulations. That, based on the foregoing, the Ministry and the Council determined in 2,440 drug products, the tests that must be carried out on them to be considered as generic drug products. That, in order to attest the interchangeability of the drug products stated above, they determined that the tests that must be carried out on them are those of dissolution profile or bio-equivalence profile, pursuant to the criteria set forth herein. That, the following criteria were taken into account to determine the type of test that corresponds to each drug product: dosage form, narrow therapeutic range and critical dose, therapeutic group, pharmacokinetic and physical and chemical characteristics. That, pursuant to the foregoing, and upon preparing the list of the drug products and of the interchangeability tests that must be carried out on each drug product, the authorities referred to above see fit to publish the following: DECISION THAT DETERMINES THE TYPE OF TEST TO DEMONSTRATE THE INTERCHANGEABILITY OF GENERIC DRUG PRODUCTS AND THAT DEFINES THE CRITERIA THAT ARE APPLICABLE TO THEM ARTICLE ONE. Criteria to determine the type of interchangeability test to consider a drug product as a generic drug product. I. The drug products that do not require to be tested for dissolution or bio-equivalence, are: a. Non-liposomal parenteral aqueous solutions, oral solutions and solutions to be inhaled with a nebulizer. b. Gases. c. Non-systemic use drug products whose administration route is ophthalmic, otic, nasal, oral, topical, rectal and vaginal and whose absorption does not pose any risks based on the analysis and research carried out by the Expert Group on Interchangeability Tests of the General Health Council. In the drug product list set forth in Article Two of this Decision, the interchangeability test referred to in subsection (i) is identified with the letter “A”. II. The oral solid drug products that fail to comply with the criteria set out in section I and section III of this decision must undergo a dissolution profile test to demonstrate the interchangeability. The conditions for the dissolution profiles test must be those set forth in the FEUM and its current supplements. When the information is not available therein, other countries’ pharmacopoeias, whose analytical procedures are carried out in accordance with the specifications set forth by specialized agencies and, ultimately, other internationally-recognized scientific literature, may be used.

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

When the dissolution profiles are not satisfactory, the gold standard bio-equivalence test or the clinical studies that demonstrate the safety and the efficacy of the product can always be carried out. In the drug product list set forth in article two of this Decision, the interchangeability test referred to in subsection (II) is identified with the letter "B" and in some special cases with the letter B*** three pH conditions ((HCl 0.1N, 1.2), 4.5 and 6.8)) based on the analysis and research of the Expert Group on Interchangeability Tests of the General Health Council. III. The following criteria must be followed to determine if bio-equivalence tests must be carried out on a drug product: CRITERION 1: DOSAGE FORM i. All immediate-release oral dosage forms with systemic action. ii. All the modified-release dosage forms. iii. All the non-oral dosage forms with systemic action (rectal, vaginal, transdermal). iv. Suspension and emulsion dosage forms. v. Drug products to be administered by inhalation of the measured dose and dry powder inhalers (see guide "Interchangeability of Drug Products Administered by Inhalation"). vi. Suspension dosage form for intramuscular administration. vii. Dosage forms with combination of drug substances that have systemic action with effect in the absorption process. CRITERION 2: NARROW THERAPEUTIC RANGE AND CRITICAL DOSE Based on the "Guidelines to Assess the Interchangeability of Drug Products that Have NTI-Drug Substances and Critical Dose":

i. All NTI-drug substances, defined as such when a ratio between the lethal dose 50 (LD50) and the effective dose 50 (ED50) lower than 2 is found in the pre-clinical studies, or if unavailable, using the ratio between the toxic concentration 10 and the effective concentration 90, or else, the ratio between the toxic dose 10 and the effective dose 90. ii. Critical dose drug substances are those therapeutic agents where small modifications in the administered doses or small variations in the concentrations in the body may cause serious therapeutic failures or serious adverse reactions. CRITERION 3: THERAPEUTIC GROUP i. All drug products belonging to the following therapeutic groups due to the need to maintain stable plasmatic concentrations and used for the treatment of serious illnesses: 1. Antibiotics 2. Hormones 3. Antineoplastics (subject to case-by-case review; apply the "Guide for Interchangeability Studies of Cancer Drug Products") 4. Inotropic agents 5. Antiepileptic drugs 6. Immunosuppressants 7. Virustatic drugs 8. Hypoglycemic agents CRITERION 4: PHARMACOKINETICS i. Drug products with non-linear pharmacokinetics. ii. Drug products with erratic absorption, with systemic action. iii. Drug products that exhibit pre-systemic metabolism. iv. Drug products that lack information about their pharmacokinetics. v. Drug products associated to efflux transporters or processes in the absorption stage. CRITERION 5: PHYSICO-CHEMICAL

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

i. Drug substances with low solubility or dose-dependent solubility. ii. Drug substances with chemical polymorphism. All the drug substances that meet any of the previous assumptions must submit a bio-equivalence test. In the drug product list set forth in article two of this Decision, the interchangeability test referred to in subsection (III) is identified with the letter “C” and in some special cases with the letters C*, C**, C*** or C****. The attached diagram describes the decision sequence to assign the corresponding interchangeability test to a certain drug product (annex 1). If there is no sufficient information on a drug product, duly attested in the international literature, the bio- equivalence test must be carried in all the cases, even when it is not included in any of the previous assumptions. The tests to demonstrate the interchangeability of generic drug products must be carried out pursuant to the Mexican Official Standard NOM-177-SSA1-2013, Which sets forth the tests and procedures to demonstrate that a drug product is interchangeable. Requirements to be complied with by Authorized Third Parties that carry out interchangeability tests. Requirements to conduct bio-comparability studies. Requirements to be complied with by Authorized Third Parties, Research Centers or Hospital Institutions that carry out bio- comparability tests. ARTICLE TWO. The drug products listed below have been registered with the Ministry of Health and met the requirements set forth in section V of article 167 of the Decree that reforms, adds and repeals several provisions of the Health Supplies Regulations, and any of the criteria referred to above:

Dosage form, Non-proprietary name Interchangeability test consideration of use

ABACAVIR Oral solution A

ABACAVIR Tablet C

ABACAVIR / LAMIVUDINE Tablet C/C

ABACAVIR / LAMIVUDINE / ZIDOVUDINE Tablet C/C/C

ACAMPROSATE Coated tablet C

ACARBOSE Tablet C*

ACEBROPHYLLINE Capsule C

ACEBROPHYLLINE Oral solution A

ACECLOFENAC Cream A

ACECLOFENAC Powder for suspension C

ACECLOFENAC Solution for injection A

ACECLOFENAC Tablet C

SWEET ALMOND OIL Cream A

SWEET ALMOND OIL / LANOLIN / GLYCERIN / Cream A/A/A/A/A PROPYLENE GLYCOL / SORBITOL

CASTOR OIL Emulsion A

MINERAL OIL Emulsion A

ACEMETACIN Capsule C

ACEMETACIN Extended-release capsule C

ACENOCOUMAROL (ACENOCUMARIN) Tablet C

ABIRATERONE ACETATE Tablet C

BETAMETHASONE ACETATE / BETAMETHASONE Suspension for injection C/C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

SODIUM PHOSPHATE

CALCIUM ACETATE / ALUMINUM SULFATE Cutaneous powder A/A

CHLORMADINONE ACETATE / ETHINYLESTRADIOL Tablet C/C

ULIPRISTAL ACETATE Tablet C

ZINC ACETATE / DIPHENHYDRAMINE Skin solution A/A

FLECAINIDE ACETATE Tablet C

ACETAZOLAMIDE Solution for injection A

ACETAZOLAMIDE Tablet C

ACETYLCYSTEINE Nasal solution A

ACETYLCYSTEINE Oral solution A

ACETYLCYSTEINE Effervescent tablet A

ACETYLDIGITOXIN Tablet C

LYSINE ACETYLSALICYLATE Oral granules for solution A

LYSINE ACETYLSALICYLATE / METOCLOPRAMIDE Powder for oral solution A/A

FLUOCINOLONE ACETONIDE Cream A

FLUOCINOLONE ACETONIDE Topical cream A

FLUOCINOLONE ACETONIDE / CLIOQUINOL Cream A/A

FLUOCINOLONE ACETONIDE / METRONIDAZOLE / Insert A/A/A NYSTATIN

FLUOCINOLONE ACETONIDE / NEOMYCIN Cream A/A

TRIAMCINOLONE ACETONIDE Ophthalmic suspension A

SODIUM ACEXAMATE / NEOMYCIN Ophthalmic ointment A/A

ACICLOVIR Cream A

ACICLOVIR Solution for injection A

ACICLOVIR Topical solution A

ACICLOVIR Oral suspension C

ACICLOVIR Tablet C

ACICLOVIR Dispersible tablet C

ACICLOVIR Skin ointment A

ACICLOVIR Ophthalmic ointment A

ACETYLSALICYLIC ACID Tablet B

ACETYLSALICYLIC ACID Extended-release tablet C

ACETYLSALICYLIC ACID Effervescent tablet A

ACETYLSALICYLIC ACID Chewable tablet B

ACETYLSALICYLIC ACID Coated tablet C

ACETYLSALICYLIC ACID / CITRIC ACID / TARTARIC ACID Powder for oral solution A/A/A/A / SODIUM BICARBONATE

ACETYLSALICYLIC ACID / ALUMINUM / MAGNESIUM Tablet B/A/A

ACETYLSALICYLIC ACID / AMLODIPINE Tablet B/C

ACETYLSALICYLIC ACID / SODIUM BICARBONATE Effervescent tablet A/A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

ACETYLSALICYLIC ACID / CAFFEINE Tablet B/A

ACETYLSALICYLIC ACID / CAFFEINE Powder for oral solution A/A

ACETYLSALICYLIC ACID / CAFFEINE / Capsule B/A/B CHLORPHENAMINE

ACETYLSALICYLIC ACID / CAFFEINE / Capsule B/A/B CHLORPHENAMINE

ACETYLSALICYLIC ACID / CAFFEINE / CHLORPHENAMINE / PARACETAMOL Tablet B/A/B/B (ACETAMINOPHEN)

ACETYLSALICYLIC ACID / CAFFEINE / CHLORPHENAMINE / PARACETAMOL Tablet B/A/B/B (ACETAMINOPHEN)

ACETYLSALICYLIC ACID / CAFFEINE / ERGOTAMINE Tablet B/A/C

ACETYLSALICYLIC ACID / CAFFEINE / PARACETAMOL Tablet B/A/B (ACETAMINOPHEN)

ACETYLSALICYLIC ACID / CAFFEINE / CAPTOPRIL Tablet B/C

ACETYLSALICYLIC ACID / CHLORPHENAMINE / Tablet B/B/B PHENYLEPHRINE

ACETYLSALICYLIC ACID / CHLORPHENAMINE / Tablet B/B/A PHENYLEPHRINE

ACETYLSALICYLIC ACID / CHLORPHENAMINE / Effervescent tablet B/B/A PHENYLEPHRINE

ACETYLSALICYLIC ACID / DIPYRIDAMOLE Capsule B/C

ACETYLSALICYLIC ACID / DIPYRIDAMOLE Extended-release capsule C/C

B/C/C/A (In phenacetin, measure the original ACETYLSALICYLIC ACID / PHENACETIN / ACETANILIDE / Tablet compound and the CAFFEINE paracetamol [acetaminophen])

ACETYLSALICYLIC ACID / METHOCARBAMOL Tablet B/C

ACETYLSALICYLIC ACID / TOCOPHEROL Chewable tablet B/A

ACEXAMIC ACID Cream A

ACEXAMIC ACID Topical cream A

ACEXAMIC ACID Oral granules A

ACEXAMIC ACID Skin ointment A

ACEXAMIC ACID / CETRIMONIUM BROMIDE Cream A/A

ACEXAMIC ACID / NEOMYCIN Topical cream A/A

ALENDRONIC ACID / CHOLECALCIFEROL Tablet B***/A

AMINOCAPROIC ACID Solution for injection A

ASCORBIC ACID Gum A

ASCORBIC ACID Solution for injection A

ASCORBIC ACID Tablet A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

ASCORBIC ACID Extended-release tablet B

ASCORBIC ACID Effervescent tablet A

ASCORBIC ACID Vaginal tablet A

ASCORBIC ACID / CALCIUM CARBONATE / CALCIUM Effervescent tablet A/A/A LACTATE GLUCONATE

ASCORBIC ACID / CIPROFLOXACIN Tablet A/C

ASCORBIC ACID / CHLORPHENAMINE / Effervescent tablet A/B/A/B PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN)

ASCORBIC ACID / CHONDROITIN / GLUCOSAMINE / Tablet A/A/C/A MANGANESE

ASCORBIC ACID / FLAVONOIDS Syrup A/A

ASCORBIC ACID / LORATADINE / PARACETAMOL Tablet A/C/B (ACETAMINOPHEN)

ASCORBIC ACID / LORATADINE / PARACETAMOL Coated tablet A/C/B (ACETAMINOPHEN)

ASCORBIC ACID / SODIUM PERCARBONATE Buccal powder A/A

ASCORBIC ACID / VINCAMINE Capsule A/C

AZELAIC ACID Skin gel A

BORIC ACID, BORAX Ophthalmic solution A

CITRIC ACID / TARTARIC ACID / SODIUM BICARBONATE Powder for oral solution A/A/A

CLAVULANIC ACID / AMOXICILLIN Oral granules for solution C/C

CLAVULANIC ACID / AMOXICILLIN / NIMESULIDE Capsule C/C/C

CLAVULANIC ACID / AMOXICILLIN / NIMESULIDE Oral suspension C/C/C

SPAGLUMIC ACID Ophthalmic solution A

FOLIC ACID Oral solution A

FOLIC ACID Tablet B

FOLIC ACID / FENOFIBRATE / METFORMIN Tablet B/C/C

FUSIDIC ACID Cream A

FUSIDIC ACID Skin ointment A

FUSIDIC ACID / BETAMETHASONE Cream A/A

IBANDRONIC ACID Solution for injection A

IBANDRONIC ACID Tablet B***

LACTIC ACID / SALICYLIC ACID Topical solution A/A

LACTIC ACID / HYDROCORTISONE Skin emulsion A/A

MEFENAMIC ACID Tablet C

NALIDIXIC ACID Oral suspension C

NALIDIXIC ACID Tablet C

NALIDIXIC ACID / PHENAZOPYRIDINE Tablet C/C

NICOTINIC ACID Tablet C

NICOTINIC ACID Extended-release tablet C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

PAMIDRONIC ACID Solution for injection A

PIPEMIDIC ACID Coated tablet C

CHENODEOXYCHOLIC ACID Capsule C

RETINOIC ACID Cream A

RISEDRONIC ACID Coated tablet B***

SALICYLIC ACID Cream A

SALICYLIC ACID Topical gel A

SALICYLIC ACID Skin solution A

SALICYLIC ACID / TRIETHANOLAMINE Cream A/A

TIAPROFENIC ACID Tablet C

THIOCTIC ACID Solution for injection A

THIOCTIC ACID Tablet C

THIOPHOSPHORIC ACID / CHELIDONIUM MAJUS L Solution for injection A/A ALKALOIDS COMPLEX

UNDECYLENIC ACID Cream A

UNDECYLENIC ACID / TRICLOSAN Cream A/A

UNDECYLENIC ACID / TRICLOSAN Cutaneous powder A/A

UNDECYLENIC ACID / ZINC UNDICELYNATE / ALUMINUM Cream A/A/A HIDROXITETRACLORIDE

UNDECYLENIC ACID / ZINC UNDICELYNATE / ALUMINUM Cutaneous powder A/A/A HIDROXITETRACLORIDE

URSODEOXYCHOLIC ACID Capsule C

URSODEOXYCHOLIC ACID Tablet C

VALPROIC ACID Capsule C

VALPROIC ACID Syrup A

ZOLEDRONIC ACID Solution for injection A

OMEGA-3 FATTY ACIDS Emulsion for injection A

ACITRETIN Capsule C

ADAPALENE Gel A

ADEFOVIR Tablet C

ADENOSINE Solution for injection A

AGOMELATINE Tablet C

WATER FOR INJECTIONS Solution for injection A

ALLANTOIN / HEPARIN / ONION EXTRACT Skin gel A/A/A

ALLANTOIN / COAL TAR Dermal suspension A/A

ALLANTOIN / COAL TAR / CLIOQUINOL Cream A/A/A

ALBENDAZOLE Oral suspension C

ALBENDAZOLE Tablet C

ALBENDAZOLE / SECNIDAZOLE Coated tablet C/C

CAMPHOR / CHONDROITIN / GLUCOSAMINE Cream A/A/A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

CAMPHOR / EUCALYPTUS / MENTHOL Ointment A/A/A

POLYVINYL ALCOHOL Ophthalmic solution A

POLYVINYL ALCOHOL / LEVOBUNOLOL Ophthalmic solution A/A HYDROCHLORIDE

POLYVINYL ALCOHOL / PREDNISOLONE / Ophthalmic suspension A/A/A SULFACETAMIDE

ALEFACEPT Solution for injection A

ALENDRONATE SODIUM Tablet B***

ALENDRONATE SODIUM Effervescent tablet A

ALPHA KETOANALOGUES OF AMINO ACIDS Tablet A

ALFACALCIDOL Capsule A

ALPHA-DIHYDROERGOCRYPTINE MESYLATE Solution A

ALPHA-DIHYDROERGOCRYPTINE MESYLATE Tablet C

ALFUZOSIN Tablet C

ALFUZOSIN Extended-release tablet C

ALFUZOSIN / FINASTERIDE Tablet C/C

ALGESTONE / ESTRADIOL Solution for injection (depot) C/C

ALIBOUR Powder A

ALMAGATE Suspension A

ALMAGATE Chewable tablet A

STARCH Solution for injection A

ALMOTRIPTAN Tablet C

ALOGLUTAMOL Oral suspension A

ALOGLUTAMOL Chewable tablet A

ALOIN / ATROPINE / D-NORPSEUDOEPHEDRINE Extended-release capsule A/C/C

ALOIN / ATROPINE SULFATE / DIAZEPAM / NORPSEUDOEPHEDRINE HYDROCHLORIDE / Extended-release capsule A/C/C/C/C TRIIODOTHYRONINE

ALLOPURINOL Tablet C

ALPRAZOLAM Oral solution A

ALPRAZOLAM Tablet C

ALPRAZOLAM Extended-release tablet C

ALPRAZOLAM Sublingual tablet C

ALPRAZOLAM / PAROXETINE Tablet C/C

ALPRAZOLAM / SERTRALINE Tablet C/C

ALPRAZOLAM / SULPIRIDE Tablet C/C

ALPROSTADIL Solution for injection A

ALPROSTADIL Suppository (urethral) A

COAL TAR Skin solution A

COAL TAR / MENTHOL Solution A/A

ALUMINUM AND MAGNESIUM, HYDROXIDE Oral suspension A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

ALUMINUM AND MAGNESIUM, HYDROXIDE Chewable tablet A

ALUMINUM, HYDROXIDE Oral suspension A

ALUMINUM, HYDROXIDE Tablet A

ALUMINUM / SODIUM BICARBONATE / BISMUTH / Powder for oral suspension A/A/A/A MAGNESIUM

ALUMINUM / ACTIVATED CARBON / STREPTOMYCIN / Oral suspension A/A/A/A/A/A MAGNESIUM / MENADIONE / SULFATHIAZOLE

ALUMINUM / DICYCLOVERINE / DIMETHICONE / Oral suspension A/C/A/A MAGNESIUM

ALUMINUM / DIMETHICONE / MAGNESIUM Gel A/A/A

ALUMINUM / DIMETHICONE / MAGNESIUM Oral suspension A/A/A

ALUMINUM / DIMETHICONE / MAGNESIUM Tablet A/A/A

ALUMINUM / HYDROCORTISONE / LIDOCAINE / ZINC Rectal ointment A/A/A/A OXIDE

ALUMINUM / MAGNESIUM / DIMETHICONE / Oral suspension A/A/A/C DICYCLOVERINE

ALUMINUM / MAGNESIUM / METOCLOPRAMIDE / Oral suspension A/A/C/A SIMETICONE

ALUMINUM / MAGNESIUM / METOCLOPRAMIDE / Tablet A/A/C/A SIMETICONE

ALVERINE / SIMETICONE Capsule C/A

AMANTADINE Solution for injection A

AMANTADINE Tablet C

AMANTADINE / CHLORPHENAMINE / PHENYLEPHRINE / Oral solution A/A/A/A PARACETAMOL (ACETAMINOPHEN)

AMANTADINE / CHLORPHENAMINE / PARACETAMOL Capsule C/B/B (ACETAMINOPHEN)

AMANTADINE / CHLORPHENAMINE / PARACETAMOL Syrup A/A/A (ACETAMINOPHEN)

AMANTADINE / CHLORPHENAMINE / PARACETAMOL Oral solution A/A/A (ACETAMINOPHEN)

AMBROXOL Soft gelatin capsule B

AMBROXOL Syrup A

AMBROXOL Solution for injection A

AMBROXOL Oral solution A

AMBROXOL Tablet B

AMBROXOL / AMOXICILLIN TRIHYDRATE Capsule B/C

AMBROXOL / AMOXICILLIN TRIHYDRATE Suspension B/C

AMBROXOL / BENZONATATE Capsule B/B

AMBROXOL / CEFALEXIN Oral suspension B/C

AMBROXOL / CEFALEXIN Tablet B/C

AMBROXOL / CLARITHROMYCIN Oral suspension B/C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

AMBROXOL / CLARITHROMYCIN Tablet B/C

AMBROXOL / CLENBUTEROL Oral solution A/A

AMBROXOL / CLENBUTEROL Tablet B/C

AMBROXOL / DEXTROMETHORPHAN Capsule B/C

AMBROXOL / DEXTROMETHORPHAN Syrup A/A

AMBROXOL / DEXTROMETHORPHAN Oral solution A/A

AMBROXOL / LEVODROPROPIZINE Oral solution A/A

AMBROXOL / LORATADINE Syrup A/A

AMBROXOL / LORATADINE Tablet B/C

AMBROXOL / LORATADINE / SALBUTAMOL Oral solution A/A/A

AMBROXOL / OXELADIN Tablet B/A

AMBROXOL / SULFAMETHOXAZOLE / TRIMETHOPRIM Oral suspension B/C/C

AMBROXOL / SULFAMETHOXAZOLE / TRIMETHOPRIM Tablet B/C/C

AMBROXOL / THEOPHYLLINE Syrup A/A

AMCINONIDE Cream A

AMPHOTERICIN B Solution for injection A

AMPHOTERICIN B Suspension for injection C

LIPOSOMAL AMPHOTERICIN Solution for injection C*

AMIFOSTINE Solution for injection A

AMIKACIN Solution for injection A

AMILORIDE / ATENOLOL / HYDROCHLOROTHIAZIDE Tablet C/C/C

AMILORIDE / HYDROCHLOROTHIAZIDE Tablet C/C

CRYSTALLINE AMINO ACIDS Solution for injection A

CRYSTALLINE AMINO ACIDS WITH ELECTROLYTES Solution for injection A/A

AMINO ACID ENRICHED WITH BRANCH-CHAIN AMINO Solution for injection A ACIDS

AMINOPHYLLINE Solution for injection A

AMIODARONE Solution for injection A

AMIODARONE Tablet C

AMISULPRIDE Solution A

AMISULPRIDE Tablet C

AMITRIPTYLINE Tablet C

AMLODIPINE Capsule C

AMLODIPINE Tablet C

AMLODIPINE / ATORVASTATIN Tablet C/C

AMLODIPINE / LOSARTAN Capsule C/C

AMLODIPINE / VALSARTAN Tablet C/C

AMLODIPINE / VALSARTAN / HYDROCHLOROTHIAZIDE Tablet C/C/C

AMOXICILLIN Capsule C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

AMOXICILLIN Solution for injection A

AMOXICILLIN Oral suspension C

AMOXICILLIN Chewable tablet C

AMOXICILLIN / CLAVULANIC ACID Granules C/C

AMOXICILLIN / CLAVULANIC ACID Solution for injection A/A

AMOXICILLIN / CLAVULANIC ACID Oral suspension C/C

AMOXICILLIN / CLAVULANIC ACID Tablet C/C

AMOXICILLIN / AMBROXOL Capsule C/B

AMOXICILLIN / AMBROXOL Suspension C/B

AMOXICILLIN / BROMHEXINE Capsule C/B

AMOXICILLIN / BROMHEXINE Suspension C/B

AMOXICILLIN / ERDOSTEINE Tablet C/B

AMOXICILLIN / PIVOXIL SULBACTAM Suspension C/C

AMOXICILLIN / PIVOXIL SULBACTAM Tablet C/C

AMOXICILLIN / SULBACTAM Solution for injection A/A

AMOXICILLIN / SULBACTAM Suspension C/C

AMPICILLIN Capsule C

AMPICILLIN Solution for injection A

AMPICILLIN Oral suspension C

AMPICILLIN Tablet C

AMPICILLIN / BROMHEXINE Capsule C/B

AMPICILLIN / BROMHEXINE Suspension C/B

AMPICILLIN / DICLOXACILLIN Capsule C/C

AMPICILLIN / DICLOXACILLIN Suspension C/C

AMPICILLIN / DICLOXACILLIN Solution for injection A/A

AMPICILLIN / SULBACTAM Solution for injection A/A

ANASTROZOLE Tablet C

AMFEPRAMONE (DIETHYLPROPION) Capsule C

AMFEPRAMONE (DIETHYLPROPION) Tablet C

ANTAZOLINE, NAPHAZOLINE Ophthalmic solution A

APREPITANT Capsule C

APROTININ Solution for injection A

ARIPIPRAZOLE (dose = 5 mg) Tablet C in healthy subjects

ARIPIPRAZOLE (Dose = 5 mg) Tablet C

ARSENIC Solution for injection A

Solution for injection (local ARTICAINE / EPINEPHRINE A/A and/or regional infiltration)

ASTEMIZOLE Oral suspension C

ASTEMIZOLE Tablet C This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

ATAZANAVIR Capsule C

ATAZANAVIR SULFATE Capsule C

ATENOLOL Tablet C

ATENOLOL / CHLORTHALIDONE Tablet C/C

ATENOLOL / NIFEDIPINE Extended-release capsule C/C

ATOMOXETINE Capsule C

ATORVASTATIN Soft gelatin capsule C

ATORVASTATIN Tablet C

ATOSIBAN Solution for injection A

ATROPINE Solution for injection A

ATROPINE Ophthalmic solution A

ATROPINE Ophthalmic ointment A

AZATHIOPRINE Tablet C

AZELASTINE Ophthalmic solution A

AZITHROMYCIN Capsule C

AZITHROMYCIN Solution for injection A

AZITHROMYCIN Oral suspension C

AZITHROMYCIN Tablet C

AZITHROMYCIN / NIMESULIDE Oral suspension C/C

AZITHROMYCIN / NIMESULIDE Tablet C/C

SULPHUR / ACETYLSALICYLIC ACID Soap A/A

SULPHUR / RESORCINOL Cream A/A

BACILLUS CASEII Oral suspension A

BACITRACIN / NEOMYCIN SULFATE Cutaneous powder A/A

BACITRACIN / NEOMYCIN SULFATE Ointment A/A

BACLOFEN Extended-release tablet C

BAMBUTEROL Oral solution A

BAMBUTEROL Tablet C

COLLOID BATH Powder A

BARNIDIPINE Extended-release capsule C

BECAPLERMIN Gel A

BECLOMETHASONE Suspension spray C*

BECLOMETHASONE / SALBUTAMOL Buccal spray C*

BELLADONNA / BUTALBITAL / CAFFEINE / ERGOTAMINE Suppository A/C/A/A

BENAZEPRIL HYDROCHLORIDE Tablet C

BENZYDAMINE Buccopharyngeal solution A

BENZYDAMINE HYDROCHLORIDE Cream A

BENZYDAMINE HYDROCHLORIDE Gel A

BENZYL Skin emulsion A

BENZATHINE BENZYLPENICILLIN Suspension for injection C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

Powder for suspension for COMPOUND BENZATHINE BENZYLPENICILLIN C injection

PROCAINE BENZYLPENICILLIN Suspension for injection C

PROCAINE BENZYLPENICILLIN WITH CRYSTALLINE Suspension for injection C BENZYLPENICILLIN

PROCAINE BENZYLPENICILLIN WITH SODIUM Suspension for injection C BENZYLPENICILLIN

CRYSTALLINE SODIUM BENZYLPENICILLIN Solution for injection A

BENSERAZIDE HYDROCHLORIDE/LEVODOPA Tablet A/C

ESTRADIOL BENZOATE/ PROGESTERONE Solution for injection A/A

SODIUM BENZOATE Oral solution A

RIZATRIPTAN BENZOATE Wafer C

RIZATRIPTAN BENZOATE Tablet C

BENZOCAINE Mucous oral gel A

BENZOCAINE Gum A

BENZOCAINE Skin solution A

BENZOCAINE CETYLPYRIDINIUM CHLORIDE Pill A

BENZOCAINE/CHLORAMPHENICOL Otic solution A

BENZOCAINE/CHLORAMPHENICOL/HYDROCORTISONE Otic solution A/A/A

BENZOCAINE/KETANSERIN Topical gel A/A

BENZOYL Skin lotion or gel A

BENZOYL AND SULPHUR Emulsion A

BENZONATATE Capsule B

BENZONATATE Suppository C

ATRACURIUM BESYLATE Solution for injection A

CISATRACURIUM BESYLATE Solution for injection A

BETAHISTINE DIHYDROCHLORIDE Tablet C

BETAMETHASONE Cream A

BETAMETHASONE Skin foam A

BETAMETHASONE Skin solution A

BETAMETHASONE Solution for injection A

BETAMETHASONE Skin suspension A

BETAMETHASONE Tablet C

BETAMETHASONE Ointment A

BETAMETHASONE ACETATE / BETAMETHASONE Suspension for injection C/C DISODIUM PHOSPHATE

BETAMETHASONE / CLIOQUINOL Cream A/A

BETAMETHASONE / CLOTRIMAZOLE Cream A/A

BETAMETHASONE / CLOTRIMAZOLE / GENTAMICIN Cream A/A/A

BETAMETHASONE / CLOTRIMAZOLE / GENTAMICIN Skin gel A/A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

BETAMETHASONE / GENTAMICIN Ophthalmic solution A/A

BETAMETHASONE / GENTAMICIN / MICONAZOLE Cream A/A/A

BETAMETHASONE / INDOMETACIN Skin gel A/A

BETAMETHASONE / INDOMETACIN / METHOCARBAMOL Capsule C/C/C

BETAMETHASONE / LORATADINE Oral solution A/A

BETAMETHASONE / MUPIROCIN Ointment A/A

BETAXOLOL Ophthalmic solution A

BEZAFIBRATE Tablet C

BEZAFIBRATE Extended-release tablet C

BICALUTAMIDE Tablet C

SODIUM BICARBONATE Solution for injection A

SODIUM BICARBONATE / OMEPRAZOLE Capsule A/C

BIFONAZOLE Cream A

BIFONAZOLE Cutaneous powder A

BIFONAZOLE Solution A

BIFONAZOLE Skin ointment A

BIFONAZOLE, UREA Ointment A

BIMATOPROST Ophthalmic solution A

BIOTIN Tablet B

BIPERIDEN Solution for injection A

BIPERIDEN Tablet C

BISACODYL Coated tablet B

BISMUTH Suppository A

BISMUTH Tablet A

BISMUTH Chewable tablet A

BISMUTH SUBSALICYLATE Oral suspension A

BISMUTH SUBCITRATE Tablet A

BISMUTH / NITAZOXANIDE Tablet A/C

BISMUTH / RANITIDINE Oral suspension A/C

BISMUTH / RANITIDINE Tablet A/C

BISOPROLOL FUMARATE Coated tablet C

BISOPROLOL FUMARATE / HYDROCHLOROTHIAZIDE Tablet C/C

BLEOMYCIN Solution for injection A

BORTEZOMIB Solution A

BOSENTAN Tablet C

BRIMONIDINE Ophthalmic gel A

BRIMONIDINE Ophthalmic solution A

BRIMONIDINE / DORZOLAMIDE / TIMOLOL Ophthalmic solution A/A/A

BROMAZEPAM Tablet C

BROMPHENIRAMINE / CAFFEINE / PARACETAMOL Tablet B/A/B

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

(ACETAMINOPHEN)

BROMPHENIRAMINE / DEXTROMETHORPHAN / Soft gelatin capsule B/C/A/B PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN)

BROMHEXINE Oral solution A

BROMHEXINE Tablet B

BROMHEXINE / CEFACLOR Oral suspension B/C

BROMHEXINE / CEFACLOR Tablet B/C

BROMHEXINE / CEFALEXIN Capsule B/C

BROMHEXINE / CEFALEXIN Oral suspension B/C

BROMHEXINE / DROPROPIZINE Syrup A/A

DEXTROMETHORPHAN HYDROBROMIDE Extended-release capsule C

BROMOCRIPTINE Tablet C

DEXTROMETHORPHAN HYDROBROMIDE / AMBROXOL Oral solution A/A HYDROCHLORIDE

DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN Syrup A/A

IPRATROPIUM BROMIDE Solution for nebulization A

OTILONIUM BROMIDE Coated tablet A

PINAVERIUM BROMIDE / DIMETHICONE Capsule A/A

BUCLIZINE Tablet C

BUDESONIDE Capsule C

BUDESONIDE Extended-release capsule C*

BUDESONIDE Inhalation powder C*

BUDESONIDE Suspension spray C*

BUDESONIDE Suspension for nebulization A

BUDESONIDE Suspension, nasal spray A

BUDESONIDE / FORMOTEROL Inhalation powder C*

BUPHENINE Tablet B

BUPHENINE / DIPHENYLPYRALINE / AMINOPHENAZONE Oral solution A/A/A

BUFLOMEDIL HYDROCHLORIDE Tablet C

BUMADIZONE CALCIUM Tablet C

BUMETANIDE Solution for injection A

BUPIVACAINE Solution for injection A

BUPIVACAINE / EPINEPHRINE Solution for injection A/A

BUPRENORPHINE Skin patch C*

BUPRENORPHINE Solution for injection A

BUPRENORPHINE Sublingual tablet C

Coated extended-release BUPROPION C tablet

BUSERELIN Subcutaneous implant C

BUSERELIN Nasal solution A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

BUSULFAN Tablet C*

BUTALBITAL / CAFFEINE / PARACETAMOL Tablet C/A/B (ACETAMINOPHEN)

BUTENAFINE Cream A

HYOSCINE BUTYL BROMIDE / PARACETAMOL Oral solution A/A (ACETAMINOPHEN)

BUTYLHYOSCINE Solution for injection A

BUTYLHYOSCINE Oral solution A

BUTYLHYOSCINE Coated tablet A

BUTYLHYOSCINE / IBUPROFEN Tablet A/C

BUTYLHYOSCINE / METAMIZOLE (DIPYRONE, Solution for injection A/A SULPYRINE)

BUTYLHYOSCINE / METAMIZOLE (DIPYRONE, Coated tablet A/C SULPYRINE)

BUTOCONAZOLE Cream A

CABERGOLINE Tablet C

CAFFEINE Tablet A

CAFFEINE / LYSINE CLONIXINATE / ERGOTAMINE Tablet A/C/A

CAFFEINE / CHLORPHENAMINE / PHENYLEPHRINE / Capsule A/B/A/B PARACETAMOL (ACETAMINOPHEN)

CAFFEINE / CHLORPHENAMINE / PHENYLEPHRINE / Tablet A/B/A/B PARACETAMOL (ACETAMINOPHEN)

CAFFEINE / CHLORPHENAMINE / PARACETAMOL Tablet A/B/B (ACETAMINOPHEN)

CAFFEINE / PHENYLEPHRINE HYDROCHLORIDE / Tablet A/A/B CHLORPHENAMINE MALEATE

CAFFEINE / DIHYDROERGOTAMINE / PARACETAMOL Tablet A/A/B (ACETAMINOPHEN)

CAFFEINE / DIHYDROERGOTAMINE / Coated tablet A/A/C PROPYPHENAZONE (ISOPROPYLANTIPYRINE)

CAFFEINE / ERGOTAMINE Coated tablet A/A

CAFFEINE / PHENYLEPHRINE / IBUPROFEN / Capsule A/A/C/C LORATADINE

CAFFEINE / PHENYLEPHRINE / PARACETAMOL Powder for oral solution A/A/A (ACETAMINOPHEN)

CAFFEINE / PHENYLEPHRINE / PARACETAMOL Tablet A/A/B (ACETAMINOPHEN)

CAFFEINE / PHENYLEPHRINE / PARACETAMOL Tablet A/A/B/A (ACETAMINOPHEN) / TERPIN

CAFFEINE / IBUPROFEN Capsule A/C

CAFFEINE / IBUPROFEN Coated tablet A/C

CAFFEINE / PARACETAMOL (ACETAMINOPHEN) Tablet A/B

CALAMINE Skin suspension A

CALAMINE / PRAMOCAINE Cream A/A

CALCIUM Effervescent tablet A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

CALCIUM Chewable tablet A

CALCIUM BROMOLACTOBIONATE Effervescent tablet A

CALCIUM CARBONATE Tablet A

CALCIUM CITRATE Oral suspension A

CALCIUM CITRATE Tablet A

CALCIUM DOBESILATE, MONOHYDRATE Capsule A

CALCIUM GLUCONATE Solution for injection A

CALCIUM / CHOLECALCIFEROL Tablet A/A

CALCIPOTRIOL Skin ointment A

CALCITONIN Solution for injection A

CALCITRIOL Soft gelatin capsule C

CANDESARTAN CILEXETIL Tablet C

CANDESARTAN CILEXETIL / HYDROCHLOROTHIAZIDE Tablet C/C

KAOLIN / COLISTIN / FURAZOLIDONE / PECTIN Oral suspension A/A/A/A

KAOLIN / COLISTIN / PECTIN Oral suspension A/A/A

KAOLIN / FURAZOLIDONE Oral suspension A/A

KAOLIN / NEOMYCIN / PECTIN Oral suspension A/A/A

KAOLIN / NEOMYCIN / PECTIN Tablet A/A/A

KAOLIN / NIFUROXACIDE / PECTIN Oral suspension A/A/A

KAOLIN / PECTIN Oral suspension A/A

KAOLIN / STREPTOMYCIN / SULFATHIAZOLE / PECTIN Oral suspension A/A/A/A

CAPECITABINE Tablet C*

CAPSAICIN Cream A

CAPTOPRIL Tablet C

CAPTOPRIL / HYDROCHLOROTHIAZIDE Tablet C/C

CARBAMAZEPINE Oral suspension C

CARBAMAZEPINE Tablet C

CARBAMAZEPINE Extended-release tablet C

CARBAMAZEPINE Chewable tablet C

CARBAZOCHROME / MENADIONE Syrup A/A

CARBAZOCHROME / MENADIONE Solution for injection A/A

CARBAZOCHROME / MENADIONE Tablet A/A

CARBETOCIN Solution for injection A

CARBIDOPA / LEVODOPA Extended-release tablet C/C

CARBOCYSTEINE Capsule C

CARBOCYSTEINE Syrup A

CARBOMER Ophthalmic gel A

ACTIVATED CARBON Powder A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

ACTIVATED CARBON Tablet A

CALCIUM CARBONATE / MAGNESIUM CARBONATE / Powder for suspension A/A/A SIMETHICONE

CALCIUM CARBONATE / CHOLECALCIFEROL / Tablet A/A/A SOYBEAN GLYCINE

CALCIUM CARBONATE / CALCIUM PROTEINATE Tablet A/A

CARBOPLATIN Solution for injection A

CARISOPRODOL Tablet C

CARISOPRODOL / MELOXICAM Tablet C/C

CARISOPRODOL / DICLOFENAC Coated tablet C/C

CARISOPRODOL / NAPROXEN Capsule C/C

CARMUSTINE Solution for injection A

CARNITINE Solution for injection A

CARNITINE / METHIONINE / THIAMINE Tablet A/A/A

CARVEDILOL Tablet C

CASPOFUNGIN Solution for injection A

CASSIA SENNA EQUIVALENT TO 2.5% OF SENNOSIDES Jelly A B

CEFACLOR Capsule C

CEFACLOR Oral suspension C

CEFACLOR Extended-release tablet C

CEFACLOR Extended-release tablet C

CEFADROXIL Capsule C

CEFADROXIL Oral suspension C

CEFALEXIN Capsule or tablet C

CEFALEXIN Oral suspension C

CEFALEXIN Extended-release tablet C

CEFALOTIN Solution for injection A

CEFDINIR Capsule C

CEFDINIR Oral suspension C

CEFDITOREN Tablet C

CEFEPIME Solution for injection A

CEFIXIME TRIHYDRATE Capsule C

CEFIXIME TRIHYDRATE Suspension C

CEFOPERAZONE Solution for injection A

CEFOTAXIME Solution for injection A

CEFPIROME Solution for injection A

CEFPODOXIME Suspension C

CEFPODOXIME Tablet C

CEFTAZIDIME Solution for injection A

CEFTIBUTEN Capsule C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

CEFTIBUTEN Tablet C

CEFTRIAXONE Solution for injection A

CEFUROXIME Solution for injection A

CEFUROXIME Oral suspension C

CEFUROXIME Tablet C

CELECOXIB Capsule C

GOTU KOLA / METRONIDAZOLE / NITROFURAL Insert A/A/A

CETYLPYRIDINIUM CHLORIDE Pill A

CETIRIZINE Soft gelatin capsule C

CETIRIZINE Oral solution A

CETIRIZINE Tablet C

CETRORELIX ACETATE Solution for injection A

CYANOCOBALAMIN / CYPROHEPTADINE Oral solution A/A

CYANOCOBALAMIN / DEXAMETHASONE / LIDOCAINE / Suspension for injection A/C/A/A/A PYRIDOXINE / THIAMINE

CYANOCOBALAMIN / DEXAMETHASONE / THIAMINE Solution for injection A/A/A

CYANOCOBALAMIN / DICLOFENAC SODIUM / PYRIDOXINE HYDROCHLORIDE / THIAMINE Coated tablet A/C/A/A MONONITRATE

CYANOCOBALAMIN / DICLOFENAC / PYRIDOXINE / Solution for injection A/A/A/A THIAMINE

CYANOCOBALAMIN / DICLOFENAC / PYRIDOXINE / Extended-release tablet A/C/A/A THIAMINE

CYANOCOBALAMIN / GABAPENTIN / THIAMINE Tablet A/C/A MONONITRATE

CYANOCOBALAMIN / PYRIDOXINE / THIAMINE Solution for injection A/A/A

CYANOCOBALAMIN / PYRIDOXINE / MELOXICAM Tablet A/A/A/C

CICLESONIDE Suspension aerosol C*

CYCLOBENZAPRINE Capsule C

CYCLOBENZAPRINE / LYSINE CLONIXINATE Tablet C/C

CYCLOPHOSPHAMIDE Solution for injection A

CYCLOPHOSPHAMIDE Coated tablet C*

CYCLOPENTOLATE Ophthalmic solution A

CICLOPIROX Cream A

CICLOPIROX Gel A

CICLOPIROX Skin solution A

CICLOSENIDE (sic) Suspension aerosol C*

CICLOSPORIN Soft gelatin capsule C

CICLOSPORIN Oral emulsion C

CICLOSPORIN Oral emulsion C

CICLOSPORIN Oily solution for injection C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

CICLOSPORIN Ophthalmic solution A

CILOSTAZOL Tablet C

CIMETIDINE Coated tablet C

CINNARIZINE Capsule C

CINNARIZINE Extended-release capsule C

CINNARIZINE Suspension C

CINNARIZINE Tablet C

CINCHOCAINE / POLICRESULEN HYDROCHLORIDE Ointment A/A

CINCHOCAINE / POLICRESULEN HYDROCHLORIDE Suppository A/A

CINITAPRIDE Granules C

CINITAPRIDE Oral solution A

CINITAPRIDE Tablet C

CIPROFIBRATE Capsule C

CIPROFLOXACIN Capsule or tablet C

CIPROFLOXACIN Solution for injection A

CIPROFLOXACIN Ophthalmic solution A

CIPROFLOXACIN Ophthalmic solution A

CIPROFLOXACIN Suspension C

CIPROFLOXACIN Extended-release tablet C

CIPROFLOXACIN Ophthalmic ointment A

CIPROFLOXACIN / DEXAMETHASONE HYDROCHLORIDE Ophthalmic solution A/A

CIPROFLOXACIN / DEXAMETHASONE Ophthalmic suspension A/A

CIPROFLOXACIN / PHENAZOPYRIDINE Tablet C/C

CIPROFLOXACIN / FLUOCINOLONE Otic solution A/A

CIPROFLOXACIN / HYDROCORTISONE Otic solution A/A

CIPROFLOXACIN / HYDROCORTISONE / LIDOCAINE Otic solution A/A/A

CYPROTERONE Tablet C

CYPROTERONE / ETHINYLESTRADIOL Coated tablet C/C

CISAPRIDE Oral suspension C

CISAPRIDE Tablet C

CISAPRIDE / RANITIDINE Oral suspension C/C

CISPLATIN Solution for injection A

CITALOPRAM Tablet C

CYTARABINE Solution for injection A

CITICOLINE Solution for injection A

CITICOLINE Tablet C

ORPHENADRINE CITRATE / PARACETAMOL Tablet C/B (ACETAMINOPHEN)

OXELADIN CITRATE / BROMHEXINE HYDROCHLORIDE Oral solution A/A

OXOLAMINE CITRATE Syrup A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

PIPERAZINE CITRATE Syrup A

SODIUM CITRATE / DEXTROMETHORPHAN / Syrup A/A/A GUAIFENESIN

SODIUM CITRATE / SODIUM LAURYL SULFATE Rectal suspension A/A

CITRULLINE Oral solution A

CLARITHROMYCIN Gel A

CLARITHROMYCIN Solution for injection A

CLARITHROMYCIN Oral suspension C

CLARITHROMYCIN Tablet C

CLEBOPRIDE Capsule C

CLEBOPRIDE Oral solution A

CLEBOPRIDE / SIMETHICONE Capsule C/A

CLEMASTINE / DEXAMETHASONE Tablet C/C

CLEMIZOLE PENICILLIN Suspension for injection C

CLEMIZOLE PENICILLIN / BENZYLPENICILLIN SODIUM Suspension for injection C/C

CLENBUTEROL Tablet C

CLINDAMYCIN Capsule C

CLINDAMYCIN Vaginal cream A

CLINDAMYCIN Vaginal foam A

CLINDAMYCIN Gel A

CLINDAMYCIN Skin gel A

CLINDAMYCIN Insert A

CLINDAMYCIN Solution for injection A

CLINDAMYCIN / FLUOCINOLONE / TERCONAZOLE Insert A/A/A

CLINDAMYCIN / KETOCONAZOLE Vaginal cream A/A

CLINDAMYCIN / KETOCONAZOLE Insert A/A

CLINDAMYCIN / KETOCONAZOLE Vaginal tablet A/A

CLINDAMYCIN / BENZOYL PEROXIDE Skin gel A/A

CLINDAMYCIN / TRETINOIN Topical gel A/A

CLIOQUINOL Cream A

CLIOQUINOL / FLUOCINONIDE Gel A/A

CLIOQUINOL / HYDROCORTISONE Cream A/A

CLOBAZAM Tablet C

CLOBENZOREX Capsule C

CLOBENZOREX Extended-release tablet C

CLOBETASOL Cream A

CLOBETASOL Lotion A

CLOBETASOL Skin solution A

CLOBETASOL Skin ointment A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

SODIUM CLODRONATE OR CLODRONIC ACID Solution for injection A

SODIUM CLODRONATE OR CLODRONIC ACID Tablet B***

CLOFARABINE Oral solution A

CLOMIFENE Tablet C

CLOMIPRAMINE Solution for injection A

CLOMIPRAMINE Coated tablet C

CLONAZEPAM Solution for injection A

CLONAZEPAM Oral solution A

CLONAZEPAM Tablet C

CLONIDINE Tablet C

LYSINE CLONIXINATE Skin gel A

LYSINE CLONIXINATE Solution for injection A

LYSINE CLONIXINATE Tablet C

LYSINE CLONIXINATE / DICLOFENAC Tablet C/C

LYSINE CLONIXINATE / HYOSCINE Tablet C/A

LYSINE CLONIXINATE / PARGEVERINE Tablet C/C

CLOPAMIDE / PINDOLOL Tablet C/C

CLOPERASTINE Capsule C

CLOPERASTINE FENDIZOATE Syrup A

CLOPIDOGREL Tablet C

CLOPIDOGREL Coated tablet C

CLOPIDOGREL / ACETYLSALICYLIC ACID Tablet C/C

CHLORAMBUCIL Tablet C

CHLORAMPHENICOL Capsule C

CHLORAMPHENICOL Solution for injection A

CHLORAMPHENICOL Ophthalmic solution A

CHLORAMPHENICOL Suspension C

CHLORAMPHENICOL Ophthalmic ointment A

LEVOROTATORY CHLORAMPHENICOL / Ointment A/A/A DEOXYRIBONUCLEASE / FIBRINOLYSIN

CHLORAMPHENICOL / CLOSTRIDIOPEPTIDASE A Ointment A/A

CHLORAMPHENICOL / DEXAMETHASONE Ophthalmic solution A/A

CHLORAMPHENICOL / DEXAMETHASONE / Ophthalmic solution A/A/A PHENYLEPHRINE

CHLORAMPHENICOL / HYDROCORTISONE Ophthalmic suspension A/A

CHLORAMPHENICOL / PREDNISONE Ophthalmic suspension A/A

CHLORAMPHENICOL / PREDNISONE Ophthalmic ointment A/A

CHLORAMPHENICOL / SULFACETAMIDE Ophthalmic solution A/A

CHLORDIAZEPOXIDE Capsule C

CHLORPHENAMINE Syrup A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

CHLORPHENAMINE Solution for injection A

CHLORPHENAMINE Tablet B

Coated extended-release CHLORPHENAMINE C tablet

CHLORPHENAMINE / AMMONIUM CHLORIDE / Syrup A/A/A DEXTROMETHORPHAN

CHLORPHENAMINE / DEXAMETHASONE Tablet B/C

CHLORPHENAMINE / DEXTROMETHORPHAN / Tablet B/C/A/B PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / DEXTROMETHORPHAN / Capsule A/C/A/B PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / DEXTROMETHORPHAN / Granules A/A/A/A PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / DEXTROMETHORPHAN / Powder A/A/A/A PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / DEXTROMETHORPHAN / Suspension B/C/A/B PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / DEXTROMETHORPHAN / Suppository B/C/A/B GUAIFENESIN / PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / DEXTROMETHORPHAN / Capsule B/C/B PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / PHENYLEPHRINE Extended-release capsule C/A

CHLORPHENAMINE / PHENYLEPHRINE Syrup A/A

CHLORPHENAMINE / PHENYLEPHRINE / GUAIFENESIN / Solution A/A/A/A PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / PHENYLEPHRINE / GUAIFENESIN / Tablet B/A/A/B PARACETAMOL (ACETAMINOPHEN)

CHLORPHENAMINE / PHENYLEPHRINE / IBUPROFEN Tablet B/A/C

CHLORPHENAMINE / PHENYLEPHRINE / MOROXIDINE Syrup A/A/A

CHLORPHENAMINE / PHENYLEPHRINE / PARACETAMOL Capsule B/A/B (ACETAMINOPHEN)

CHLORPHENAMINE / PHENYLEPHRINE / PARACETAMOL Oral solution A/A/A (ACETAMINOPHEN)

CHLORPHENAMINE / PHENYLEPHRINE / PARACETAMOL Tablet B/A/B (ACETAMINOPHEN)

CHLORPHENAMINE / PHENYLEPHRINE / PARACETAMOL Chewable tablet B/A/B (ACETAMINOPHEN)

CHLORPHENAMINE / PHENYLEPHRINE / PARACETAMOL Coated tablet B/A/B (ACETAMINOPHEN)

CHLORPHENAMINE / GUAIFENESIN / LIDOCAINE / Solution for injection A/A/A/A PROXYPHYLLINE

CHLORPHENAMINE / GUAIFENESIN / PARACETAMOL Oral solution A/A/A (ACETAMINOPHEN)

CHLORPHENAMINE / GUAIFENESIN / PROXYPHYLLINE Capsule B/B/C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

CHLORPHENAMINE / GUAIACOL / LIDOCAINE / Solution for injection A/A/A/A METAMIZOLE

CHLORPHENAMINE / METAMIZOLE Solution for injection A/A

CHLORPHENAMINE / PARACETAMOL Capsule B/B (ACETAMINOPHEN)

CHLORPHENAMINE / PARACETAMOL Solution A/A (ACETAMINOPHEN)

CHLORPHENAMINE / PARACETAMOL Tablet B/B (ACETAMINOPHEN)

CHLORPHENAMINE / PARACETAMOL Chewable tablet B/B (ACETAMINOPHEN)

CHLORPHENAMINE / PARAMETHASONE Suspension B/C

CHLORPHENAMINE / PARAMETHASONE Tablet B/C

AMANTADINE HYDROCHLORIDE / CHLORPHENAMINE Tablet C/B/B MALEATE / PARACETAMOL (ACETAMINOPHEN) CD 90%

AMBROXOL HYDROCHLORIDE / LORATADINE Solution A/A

AMBROXOL HYDROCHLORIDE / LORATADINE / CITRIC Oral solution A/A/A ACID

AMBROXOL HYDROCHLORIDE / SALBUTAMOL Solution A/A SULFATE

BROMHEXINE HYDROCHLORIDE / OXELADIN CITRATE Tablet B/A

BROMHEXINE HYDROCHLORIDE / ERYTHROMYCIN Suspension B/C ETHYLSUCCINATE

Coated extended-release CLOMIPRAMINE HYDROCHLORIDE C tablet

DEXRAZOXANE HYDROCHLORIDE Solution for injection A

DIPHENHYDRAMINE HYDROCHLORIDE / GUAIFENESIN Syrup A/A

EPINASTINE HYDROCHLORIDE Ophthalmic solution A

FENPROPOREX HYDROCHLORIDE / DIAZEPAM Capsule C/C

FEXOFENADINE HYDROCHLORIDE Oral suspension C

OXYBUTYNIN HYDROCHLORIDE Tablet C

SEVELAMER HYDROCHLORIDE Tablet A

CHLORIMIPRAMINE Solution for injection A

CHLORMADINONE Tablet C

CHLORMADINONE / MESTRANOL Tablet C/C

CHLORDIAZEPOXIDE Solution for injection A

CHLOROPYRAMINE Solution for injection A

CHLOROPYRAMINE HYDROCHLORIDE Coated tablet C

CHLORPROMAZINE Tablet C

CHLOROQUINE Tablet C

CHLORPROPAMIDE Tablet C

CHLORPROPAMIDE / METFORMIN Extended-release tablet C/C

CHLORTALIDONE Tablet C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

CHLORTALIDONE / RESERPINE Tablet C/C

ACETYLCHOLINE CHLORIDE Ophthalmic solution A

POTASSIUM CHLORIDE Solution for injection A

Ophthalmic ointment or SODIUM CHLORIDE A solution

SODIUM CHLORIDE Solution for injection A

SODIUM CHLORIDE / GLUCOSE Solution for injection A/A

CHLORZOXAZONE / KETOPROFEN / CALCIUM Tablet C/C/A CARBONATE

CHLORZOXAZONE / KETOPROFEN / THIAMINE Tablet C/C/A/A HYDROCHLORIDE / PYRIDOXINE HYDROCHLORIDE

CHLORZOXAZONE / PARACETAMOL (ACETAMINOPHEN) Tablet C/B

CLOTRIMAZOLE Vaginal cream A

CLOTRIMAZOLE Insert A

CLOTRIMAZOLE Cutaneous powder A

CLOTRIMAZOLE Skin solution A

CLOTRIMAZOLE / DEXAMETHASONE ACETATE / Cream A/A/A NEOMYCIN SULFATE

CLOTRIMAZOLE / DEXAMETHASONE ACETATE Cream A/A

CLOZAPINE Tablet C

COBAMAMIDE / THIOCOLCHICOSIDE Solution for injection A/A

CODEINE / PARACETAMOL (ACETAMINOPHEN) Capsule C/B

CODEINE / DICLOFENAC Coated tablet C/C

CODEINE / DROFENINE / PROPYPHENAZONE Suppository C/A/C

CODEINE / EPHEDRINE Tablet C/A

CODEINE / PARACETAMOL (ACETAMINOPHEN) Capsule C/B

CODERGOCRINE Tablet C

CODERGOCRINE MESYLATE Solution for injection A

CODERGOCRINE MESYLATE Oral solution A

COLLAGENASE Gel A

COLCHICINE Tablet C

CHOLECALCIFEROL Tablet A

CHOLECALCIFEROL / RETINOL / ZINC OXIDE Cream A/A/A

COLESTYRAMINE Oral powder A

COLISTIN / FURAZOLIDONE Tablet A/B

VITAMIN B COMPLEX Tablet A

IRON POLYMALTOSE COMPLEX EQUIVALENT TO Solution for injection A ELEMENTAL IRON

IRON OXIDE SACCHARATED COMPLEX EQUIVALENT TO Solution for injection A ELEMENTAL IRON

IRON POLYMALTOSE COMPLEX EQUIVALENT TO Solution A This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

ELEMENTAL IRON

IRON POLYMALTOSE COMPLEX EQUIVALENT TO Solution A ELEMENTAL IRON

IRON POLYMALTOSE / FOLIC ACID COMPLEX Coated tablet A/B

CHONDROITIN / HYPROMELLOSE Ophthalmic solution A/A

CHONDROITIN Capsule A

SODIUM CROMOGLICATE Ophthalmic solution A

SODIUM CROMOGLICATE Suspension spray C*

CROSPOVIDONE Oral powder A

CROTAMITON Cream A

Coated extended-release COUMARIN / TROXERUTIN C/A tablet

DABIGATRAN Capsule C

DACARBAZINE Solution for injection A

DACTINOMYCIN Solution for injection A

DALTEPARIN Solution for injection C*

DANAZOL Capsule or tablet C

DAPOXETINE Tablet C

DAPSONE Oral solution A

DAPSONE Tablet C

DARIFENACIN Tablet C

DARIFENACIN Extended-release tablet C

DARUNAVIR Oral suspension C

DARUNAVIR Tablet C

DAUNORUBICIN Solution for injection A

HALOPERIDOL DECANOATE Solution for injection A

DEFERASIROX Dispersible tablet C

DEFLAZACORT Tablet C

DEGARELIX Solution for injection A

DEHYDROEMETINE Solution for injection A

DELAVIRIDINE (sic) Tablet C

DESFLURANE Volatile liquid A

DESIPRAMINE HYDROCHLORIDE Coated tablet C

DESLANOSIDE Solution for injection A

DESLORATADINE Syrup A

DESLORATADINE Tablet C

DESLORATADINE / BETAMETHASONE Syrup A/A

DESMOPRESSIN Suspension aerosol A

DESMOPRESSIN Solution for injection A

DESMOPRESSIN Tablet C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

DESOGESTREL Tablet C

DESOGESTREL / ETHINYLESTRADIOL Tablet C/C

DESONIDE Cream A

DEOXYRIBONUCLEASE / FIBRINOLYSIN Ointment A/A

DESVENLAFAXINE Sustained-release tablet C

DEXAMETHASONE Solution for injection A

DEXAMETHASONE Ophthalmic solution A

DEXAMETHASONE Ophthalmic suspension A

DEXAMETHASONE Tablet C

DEXAMETHASONE / PHENYLBUTAZONE Tablet C/C

DEXAMETHASONE / PHENYLEPHRINE / NEOMYCIN Nasal solution A/A/A

DEXAMETHASONE / PHENYLEPHRINE / NEOMYCIN / Ophthalmic solution A/A/A/A POLYMYXIN B

DEXAMETHASONE / INDOMETACIN Capsule C/C

DEXAMETHASONE / NAPHAZOLINE / TOBRAMYCIN Ophthalmic solution A/A/A

DEXAMETHASONE / NEOMYCIN Ophthalmic solution A/A

DEXAMETHASONE / NEOMYCIN / POLYMYXIN Ophthalmic ointment A/A/A

DEXAMETHASONE / NETILMICIN Solution A/A

DEXAMETHASONE / TOBRAMYCIN Ophthalmic solution A/A

DEXAMETHASONE / TOBRAMYCIN Ophthalmic suspension A/A

DEXAMETHASONE / TOBRAMYCIN Ophthalmic ointment A/A

DEXAMETHASONE / VANCOMYCIN Ophthalmic solution A/A

DEXIBUPROFEN Coated tablet C

DEXKETOPROFEN Tablet C

DEXTRAN Solution for injection A

DEXTROMETHORPHAN Syrup A

DEXTROMETHORPHAN Buccal strip C

DEXTROMETHORPHAN / DOXYLAMINE / Capsule C/B/A/B PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN)

DEXTROMETHORPHAN / PHENYLEPHRINE / Oral granules for solution A/A/A PHENIRAMINE

DEXTROMETHORPHAN / PHENYLEPHRINE / Capsule C/A/A GUAIFENESIN

DEXTROMETHORPHAN / PHENYLEPHRINE / Syrup A/A/A GUAIFENESIN

DEXTROMETHORPHAN / PHENYLEPHRINE / Oral solution A/A/A GUAIFENESIN

DEXTROMETHORPHAN / PHENYLEPHRINE / Capsule C/A/B PARACETAMOL (ACETAMINOPHEN)

DEXTROMETHORPHAN / PHENYLEPHRINE / Oral granules for solution A/A/A PARACETAMOL (ACETAMINOPHEN)

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

DEXTROMETHORPHAN / PHENYLEPHRINE / Oral solution A/A/A PARACETAMOL (ACETAMINOPHEN)

DEXTROMETHORPHAN / PHENYLEPHRINE / Tablet C/A/B PARACETAMOL (ACETAMINOPHEN)

DEXTROMETHORPHAN / PHENIRAMINE / CHLORPHENAMINE / PARACETAMOL Oral granules for solution A/A/A/A (ACETAMINOPHEN)

DEXTROMETHORPHAN / GUAIFENESIN / PARACETAMOL Suppository C/A/B (ACETAMINOPHEN)

DEXTROMETHORPHAN / LORATADINE / PARACETAMOL Capsule C/C/B (ACETAMINOPHEN)

DEXTROMETHORPHAN / PARACETAMOL Capsule C/B (ACETAMINOPHEN)

DEXTROMETHORPHAN / PARACETAMOL Tablet C/B (ACETAMINOPHEN)

DEXTROMETHORPHAN / SULFOGUAIACOLATE Syrup A/A

DEXTROMETHORPHAN / POTASSIUM Syrup A/A SULFOGUAIACOLATE

DEXTROPROPOXYPHENE Capsule C

DEXTROPROPOXYPHENE HYDROCHLORIDE / Tablet C/B PARACETAMOL (ACETAMINOPHEN)

DIACEREIN Capsule C

DIACEREIN / MELOXICAM Capsule C/C

DIAZEPAM Capsule C

DIAZEPAM Rectal gel C

DIAZEPAM Solution for injection A

DIAZEPAM Tablet C

DIAZEPAM / SULPIRIDE Tablet C/C

DIAZOXIDE Solution for injection A

DICYCLOVERINE Capsule C

DICLOFENAC Soft gelatin capsule C

DICLOFENAC Cream A

DICLOFENAC Gel A

DICLOFENAC Gel A

DICLOFENAC Skin gel A

DICLOFENAC Local-action skin patch C*

DICLOFENAC Solution (spray) A

DICLOFENAC Skin solution A

DICLOFENAC Solution for injection A

DICLOFENAC Ophthalmic solution A

DICLOFENAC Oral solution A

DICLOFENAC Suppository C

DICLOFENAC Suspension C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

DICLOFENAC Tablet C

DICLOFENAC Extended-release tablet C

DICLOFENAC Dispersible tablet C

DICLOFENAC Coated tablet C

DICLOFENAC (SODIUM) Effervescent tablet A

Powder for solution for DICLOFENAC POTASSIUM A injection

DICLOFENAC POTASSIUM Suspension C

DICLOFENAC SODIUM / MISOPROSTOL Capsule C/C

DICLOFENAC SODIUM / MISOPROSTOL Extended-release capsule C/C

DICLOFENAC / VITAMIN B COMPLEX Coated tablet C/A

DICLOFENAC / LIDOCAINE Skin gel A/A

DICLOFENAC / PARACETAMOL (ACETAMINOPHEN) Tablet C/B

DICLOFENAC / PRIDINOL Tablet C/C

DICLOFENAC / TOBRAMYCIN Ophthalmic solution A/A

DICLOXACILLIN Capsule or tablet C

DICLOXACILLIN Solution for injection A

DICLOXACILLIN Oral suspension C

DIDANOSINE Capsule C

Capsule with film-coating DIDANOSINE C granules

DIDANOSINE Oral solution A

DIDANOSINE Tablet C

DIDANOSINE Chewable tablet C

DYDROGESTERONE Tablet C

DIENOGEST Tablet C

DIENOGEST / ETHINYLESTRADIOL Tablet C/C

DIETHYLSTILBESTROL Tablet C

DIPHENHYDRAMINE Capsule B

DIPHENHYDRAMINE Syrup A

DIPHENHYDRAMINE Buccal strip A

DIPHENHYDRAMINE Solution for injection A

DIPHENHYDRAMINE Tablet B

DIPHENHYDRAMINE / PHENYLEPHRINE / Oral granules for solution A/A/A PARACETAMOL (ACETAMINOPHEN)

DIPHENHYDRAMINE / PHENYLEPHRINE / Tablet B/A/B PARACETAMOL (ACETAMINOPHEN)

DIPHENHYDRAMINE / IBUPROFEN Soft gelatin capsule B/C

DIPHENHYDRAMINE / PARACETAMOL Tablet B/B (ACETAMINOPHEN)

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

DIFENIDOL Solution for injection A

DIFENIDOL Tablet C

DIFLORASONE DIACETATE Cream A

DIFLORASONE DIACETATE Ointment A

DIFLUCORTOLONE Cream A

DIGOXIN Elixir C*

DIGOXIN Solution for injection A

DIGOXIN Tablet C*

DIHYDROERGOCRISTINE METHANESULFATE (sic) / Solution A/A PIRACETAM

DIHYDROERGOTAMINE MESYLATE Solution A

DIHYDROERGOTAMINE / CAFFEINE / PARACETAMOL Coated tablet A/A/B (ACETAMINOPHEN)

DILTIAZEM Skin gel A

DILTIAZEM Extended-release tablet C

DILTIAZEM Coated tablet C

DIMENHYDRINATE Soft gelatin capsule B

DIMENHYDRINATE Solution for injection A

DIMENHYDRINATE Oral solution A

DIMENHYDRINATE Suppository C

DIMENHYDRINATE Tablet B

DIMETHICONE Soft gelatin capsule A

DIMETHICONE Suspension A

DIMETHICONE / FAMOTIDINE / MAGALDRATE Gel A/A/A

DIMETHICONE / MAGALDRATE Gel A/A

DIMETHICONE / MAGALDRATE Oral suspension A/A

DIMETHICONE / MAGALDRATE Chewable tablet A/A

DIMETHICONE / PIPENZOLATE Oral suspension A/A

DIMETHICONE / METOCLOPRAMIDE / PANCREATIN Capsule A/C/A

DIMETINDENE Skin emulsion A

DIMETINDENE Skin gel A

DINOPROSTONE Gel A

DINOPROSTONE Insert A

DIOSMIN Coated tablet A

DIOSMIN / HESPERIDIN Tablet A/A

DIOSMIN / HESPERIDIN Coated tablet A/A

DIPYRIDAMOLE Capsule C

DIPYRIDAMOLE Solution for injection A

DIPYRIDAMOLE Coated tablet C

BECLOMETHASONE DIPROPIONATE Suspension spray C*

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

BECLOMETHASONE DIPROPIONATE Suspension for nebulization A

BETAMETHASONE DIPROPIONATE Ointment A

BETAMETHASONE DIPROPIONATE / BETAMETHASONE Suspension for injection C/C SODIUM PHOSPHATE

DISOPYRAMIDE Capsule or tablet C

DISULFIRAM Tablet C

DIIODOHYDROXYQUINOLINE Suspension A

DIIODOHYDROXYQUINOLINE Tablet A

DIIODOHYDROXYQUINOLINE / ACTIVATED CHARCOAL / Tablet B/A/C/B FURAZOLIDONE / HOMATROPINE METHYLBROMIDE

DIIODOHYDROXYQUINOLINE / FURAZOLIDONE / KAOLIN Suspension A/A/A/A/A / HOMATROPINE / PECTIN

DIIODOHYDROXYQUINOLINE / FURAZOLIDONE / Tablet A/A/A HOMATROPINE

DIIODOHYDROXYQUINOLINE / HYDROCORTISONE Cream A/A

DIIODOHYDROXYQUINOLINE / METRONIDAZOLE Capsule A/C

DIIODOHYDROXYQUINOLINE / METRONIDAZOLE Oral suspension A/C

DIIODOHYDROXYQUINOLINE / METRONIDAZOLE Tablet A/C

D-NORPSEUDOEPHEDRINE HYDROCHLORIDE / ALOIN / ATROPINE SULFATE / DIAZEPAM / TRIIODOTHYRONINE Capsule C/A/C/C/C SODIUM

DOBUTAMINE Liquid A

DOCETAXEL Solution for injection A

DOLASETRON MESYLATE Solution for injection A

DOLASETRON MESYLATE Coated tablet C

DOLUTEGRAVIR Tablet C

DOMPERIDONE Suspension C

DOMPERIDONE Tablet C

DOMPERIDONE Extended-release tablet C

DONEPEZIL Tablet C

DOPAMINE Solution for injection A

Suspension for intravenous DORIPENEM C injection

DORZOLAMIDE Ophthalmic solution A

DORZOLAMIDE / TIMOLOL Solution A/A

DOXAZOSIN Tablet C

DOXEPIN Capsule C

DOXYCYCLINE Capsule C

DOXYLAMINE Tablet C

DOXOFYLLINE Tablet C

PEGYLATED LIPOSOMAL DOXORUBICIN Suspension for injection C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

DRONEDARONE Tablet C

DROPROPIZINE Syrup A

DROPROPIZINE Tablet C

DROSPERINONE / ETHINYLESTRADIOL Coated tablet C/C

DROSPIRENONE / ESTRADIOL Tablet C/C

DROTAVERIN HYDROCHLORIDE Solution for injection A

DROTAVERIN HYDROCHLORIDE Tablet C

DULOXETINE Capsule C

DUTASTERIDE Capsule C

DUTASTERIDE / TAMSULOSIN HYDROCHLORIDE Capsule C/C

EBASTINE Wafer C

EBASTINE Solution A

EBASTINE Tablet C

ECONAZOLE Cream A

DISODIUM EDETATE Solution for injection A

EFAVIRENZ Capsule C

EFAVIRENZ / EMTRICITABINE / TENOFOVIR Tablet C/C/C

EFAVIRENZ / EMTRICITABINE / TENOFOVIR / Tablet C/C/C DISOPROXIL FUMARATE

EPHEDRINE Solution for injection A

ELECTROLYTES Oral solution A

ORAL ELECTROLYTES Powder A

ELETRIPTAN Tablet C

EMTRICITABINE Capsule C

EMTRICITABINE / TENOFOVIR Tablet C/C

ENALAPRIL Solution for injection A

ENALAPRIL Tablet C

ENALAPRIL / HYDROCHLOROTHIAZIDE Tablet C/C

NORETHISTERONE ENANTATE Oily solution for injection C

ENFLURANE Liquid A

ENFUVIRTIDE Solution for injection A

ENOXAPARIN SODIUM Solution for injection C*

ENOXOLONE Topical solution A

ENTACAPONE / LEVODOPA / CARBIDOPA Tablet C/C/C

ENTECAVIR Oral solution A

ENTECAVIR Tablet C

EPIDOXORUBICIN Aqueous solution for injection A

EPINASTINE Tablet C

EPINEPHRINE Solution for injection A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

Solution for injection (local EPINEPHRINE / MEPIVACAINE A/A and/or regional infiltration)

EPIRUBICIN Solution for injection A

EPLERENONE Coated tablet C

EPROSARTAN Tablet C

ERDOSTEINE Capsule C

ERDOSTEINE Suspension B

ERDOSTEINE Tablet B

ERGOMETRINE Solution for injection A

ERGOTAMINE / CAFFEINE Tablet or coated tablet A/A

ERYTHROMYCIN Skin gel A

ERYTHROMYCIN Skin solution A

ERYTHROMYCIN Solution for injection A

ERYTHROMYCIN Oral suspension C

ERYTHROMYCIN Tablet C

ERYTHROMYCIN Ophthalmic ointment A

ERYTHROMYCIN / ZINC ACETATE Skin solution A/A

ERYTHROMYCIN / BROMHEXINE Tablet C/B

ERYTHROMYCIN / BENZOYL PEROXIDE Skin gel A/A

ERYTHROMYCIN / TRETINOIN Gel A/A

ERLOTINIB Tablet C

ERTAPENEM Solution for injection A

ESCITALOPRAM Tablet C

ESMOLOL Solution for injection A

ESOMEPRAZOLE Granules C

ESOMEPRAZOLE Solution A

ESOMEPRAZOLE Tablet C

ESOMEPRAZOLE STRONTIUM Extended-release capsule C

SPECTINOMYCIN Suspension for injection C

SPIRAMYCIN / METRONIDAZOLE Tablet C/C

SPIRONOLACTONE Tablet C

SPIRONOLACTONE / FUROSEMIDE Capsule C/C

SPIRONOLACTONE / THIABUTAZIDE Tablet C/C

STAVUDINE Capsule C

ESTAZOLAM Tablet C

POLYSACCHARIDE POLYSULPHURIC ACID ESTER Insert A

ETHYL ESTERS OMEGA 3 FATTY ACIDS Capsule A

ESTRADIOL Vaginal cream A

ESTRADIOL Skin gel A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

ESTRADIOL Skin topical gel A

ESTRADIOL Patch C*

ESTRADIOL VALERATE / MEDROXYPROGESTERONE Tablet C/C ACETATE

ESTRADIOL / 17-BETA TRIMEGESTONE Coated tablet C/C

ESTRADIOL / CYPROTERONE Coated tablet C/C

ESTRADIOL / HYDROXYPROGESTERONE Oily solution for injection C/C

ESTRADIOL / LEVONORGESTREL Patch C*/C*

ESTRAMUSTINE Capsule C

STREPTOMYCIN Capsule A

Powder for solution for STREPTOMYCIN A injection

STREPTOKINASE Solution for injection A

STREPTOKINASE / STREPTODORNASE Tablet A/A

ESTRIOL Cream A

ESTRIOL Insert A

ESTRIOL Tablet C

ESTRIOL SUCCINATE Tablet C

CONJUGATED ESTROGENS Vaginal cream A

CONJUGATED ESTROGENS Tablet or coated tablet C

CONJUGATED ESTROGENS / Coated tablet C/C MEDROXYPROGESTERONE

ETHAMBUTOL Tablet C

ETAMSYLATE Solution for injection A

ETAMSYLATE Tablet C

ETILEFRINE HYDROCHLORIDE Extended-release capsule C

ETILEFRINE HYDROCHLORIDE Solution A

ETILEFRINE HYDROCHLORIDE Solution for injection A

ETILEFRINE HYDROCHLORIDE Tablet C

ETHINYLESTRADIOL / ETONOGESTREL Powder (vaginal device) C/C

ETHINYLESTRADIOL / GESTODENE Tablet C/C

ETHINYLESTRADIOL / GESTODENE Coated tablet C/C

ETHINYLESTRADIOL / LEVONORGESTREL Tablet C/C

ETHINYLESTRADIOL / NORELGESTROMIN Skin patch C*

ETHINYLESTRADIOL / NORETHISTERONE Tablet C/C

ETHINYLESTRADIOL / NORGESTREL Tablet C/C

ETODOLAC Capsule C

ETOFENAMATE Cream A

ETOFENAMATE Gel A

ETOFENAMATE Skin solution A

ETOFENAMATE Solution for injection A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

ETOFENAMATE / BENZYL NICOTINATE Cream A/A

ETOFIBRATE Capsule C

ETOFIBRATE Extended-release capsule C

ETOMIDATE Solution for injection A

ETONOGESTREL Implant C

ETONOGESTREL / ETHINYLESTRADIOL Vaginal ring C/C

ETOPOSIDE Solution for injection A

ETORICOXIB Tablet C

ETHOSUXIMIDE Syrup A

ETRAVIRINE Tablet C

EVEROLIMUS (Doses > 10 mg) Tablet C in patients

EVEROLIMUS (Doses  10 mg) Tablet C in healthy subjects

EXEMESTANE Coated tablet C

EZETIMIBE Tablet C

EZETIMIBE / SIMVASTATIN Tablet C/C

FAMCICLOVIR Tablet C

FAMOTIDINE Soft gelatin capsule C

FAMOTIDINE Tablet C

FAMOTIDINE Tablet C

FAMOTIDINE Chewable tablet C

FELYPRESSIN / PRILOCAINE Solution for injection A/A

FELODIPINE Extended-release tablet C

Coated extended-release FELODIPINE / RAMIPRIL C/C tablet

PHENAZONE (ANTIPYRINE) / LIDOCAINE Otic solution A

PHENAZOPYRIDINE Tablet C

PHENAZOPYRIDINE / NORFLOXACIN Tablet C/C

PHENAZOPYRIDINE / SULFAMETHOXAZOLE / Capsule C/C/C TETRACYCLINE

CLOPERASTINE FENDIZOATE Suspension C

PHENYLBUTAZONE Solution for injection A

PHENYLBUTAZONE Coated tablet C

PHENYLBUTAZONE / PREDNISONE Tablet C/C

PHENYLBUTAZONE / PREDNISONE Coated tablet C/C

SODIUM PHENYLBUTYRATE Tablet C

PHENYLEPHRINE Nasal solution A

PHENYLEPHRINE Ophthalmic solution A

PHENYLEPHRINE / SHARK LIVER OIL Suppository A/A

PHENYLEPHRINE / CHLORPHENAMINE / PARACETAMOL Chewable tablet A/B/B (ACETAMINOPHEN) This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

PHENYLEPHRINE / DEXTROMETHORPHAN / Syrup A/C/B CHLORPHENAMINE

PHENYLEPHRINE / PHENIRAMINE / PARACETAMOL Oral granules for solution A/A/A (ACETAMINOPHEN)

PHENYLEPHRINE / PHENIRAMINE / PARACETAMOL Oral granules for solution A/A/A (ACETAMINOPHEN)

PHENYLEPHRINE / LORATADINE Capsule A/C

PHENYLEPHRINE / LORATADINE Syrup A/A

PHENYLEPHRINE / LORATADINE Solution A/A

PHENYLEPHRINE / LORATADINE Tablet A/C

PHENYLEPHRINE / LORATADINE Extended-release tablet A/C

PHENYLEPHRINE / LORATADINE / PARACETAMOL Oral granules for solution A/A/A (ACETAMINOPHEN)

PHENYLEPHRINE / LORATADINE / PARACETAMOL Tablet A/C/B (ACETAMINOPHEN)

PHENYLEPHRINE / LORATADINE / PARACETAMOL Tablet A/C/B (ACETAMINOPHEN)

PHENYLEPHRINE / LORATADINE / PARACETAMOL Tablet A/C/B (ACETAMINOPHEN)

PHENYLEPHRINE / LORATADINE / PARACETAMOL Extended-release tablet A/C/B (ACETAMINOPHEN)

PHENYLEPHRINE / NAPROXEN Capsule A/C

PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN) Capsule A/B PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN) Oral granules for solution A/A PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN) Oral granules for solution A/A PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN) Powder for oral solution A/A PHENYLEPHRINE / PARACETAMOL (ACETAMINOPHEN) Tablet A/B PHENYLEPHRINE / PREDNISOLONE / SULFACETAMIDE Ophthalmic suspension A/A/A PHENYLEPHRINE / TRIPROLIDINE Tablet A/B*** PHENYLEPHRINE / ZINC Ophthalmic solution A/A PHENIRAMINE / NAPHAZOLINE Ophthalmic solution A/A PHENYTOIN (DIPHENYLHYDANTOIN) Oral suspension C PHENYTOIN SODIUM Capsule or tablet C PHENYTOIN SODIUM Solution for injection A PHENYTOIN SODIUM / PHENOBARBITAL Tablet C/C PHENOBARBITAL Elixir A

PHENOBARBITAL Solution for injection A PHENOBARBITAL Tablet C FENOFIBRATE Capsule C FENOFIBRATE / SIMVASTATIN Tablet C/C PHENOLPHTHALEIN Tablet A PHENOTHRIN Skin solution A PHENOTHRIN / LIDOCAINE Skin solution A/A PHENOXYMETHYLPENICILLIN POTASSIUM Suspension C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

FENPROPOREX Tablet C FENPROPOREX Extended-release tablet C FENTANYL Patch C* FENTANYL Solution for injection A PHENTERMINE Capsule C PHENTERMINE Tablet C PHENTERMINE Extended-release tablet C FENTICONAZOLE NITRATE Cream A FENTICONAZOLE NITRATE Insert A FEPRADINOL HYDROCHLORIDE Gel A FEPRADINOL HYDROCHLORIDE Solution A FEXOFENADINE Oral suspension C FEXOFENADINE (FEXOFENADINE HYDROCHLORIDE) Capsule C FEXOFENADINE (FEXOFENADINE HYDROCHLORIDE) Tablet C FEXOFENADINE HYDROCHLORIDE / PHENYLEPHRINE Tablet C/A HYDROCHLORIDE

FEXOFENADINE / PHENYLEPHRINE Tablet C/A

FINASTERIDE Coated tablet C

FINGOLIMOD Capsule C

Solution or emulsion for PHYTOMENADIONE A injection

FLAVOXATE Coated tablet C

PHLOROGLUCINOL Solution for injection A

PHLOROGLUCINOL Tablet C

PHLOROGLUCINOL / TRIMETHYLPHLOROGLUCINOL Capsule C/C

PHLOROGLUCINOL / TRIMETHYLPHLOROGLUCINOL Solution A/A (sic)

PHLOROGLUCINOL / TRIMETHYLPHLOROGLUCINOL Solution for injection A/A (sic)

FLUBENDAZOLE Oral suspension A

FLUCLOXACILLIN Capsule C

FLUCLOXACILLIN Oral solution A

FLUCONAZOLE Capsule C

FLUCONAZOLE Solution for injection A

FLUDARABINE PHOSPHATE Solution for injection A

FLUDARABINE PHOSPHATE Tablet C*

FLUPHENAZINE / NORTRIPTYLINE Coated tablet C/C

FLUPHENAZINE Solution for injection A

FLUMAZENIL Solution for injection A

FLUNARIZINE Capsule or tablet C

FLUNITRAZEPAM Solution for injection A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

FLUNITRAZEPAM Tablet C

FLUOCINONIDE Gel A

FLUOROMETHALONE Ophthalmic solution A

FLUOROMETHOLONE Ophthalmic suspension A

FLUOROURACIL Solution for injection A

FLUOROURACIL Ointment A

FLUOXETINE Capsule C

FLUOXETINE Dispersible tablet C

FLUPENTIXOL Solution for injection (depot) C

FLUPENTIXOL Coated tablet C

FLURBIPROFEN Tablet C

FLURBIPROFEN SODIUM Ophthalmic solution A

FLUTAMIDE Tablet C

FLUTICASONE Oral inhalation spray C*

FLUTICASONE Cream A

FLUTICASONE Nasal suspension A

FLUTICASONE Suspension for nebulization A

FLUTICASONE / SALMETEROL Oral inhalation powder C*

Oral inhalation suspension FLUTICASONE / SALMETEROL C* spray

FLUTICASONE / SALMETEROL inhalation suspension spray C*

FLUTRIMAZOLE Cream A

FLUTRIMAZOLE Gel A

FLUTRIMAZOLE Solution A

FLUVASTATIN Capsule C

FLUVOXAMINE MALEATE Tablet C

CALCIUM FOLINATE (FOLINIC ACID) Solution for injection A

CALCIUM FOLINATE (FOLINIC ACID) Tablet B

FORMOTEROL Capsule for inhalation C*

FOSAMPRENAVIR Tablet C

FOSAMPRENAVIR CALCIUM Coated tablet C

FOSAPREPITANT Solution for injection A

CLINDAMYCIN PHOSPHATE Topical solution A

POTASSIUM PHOSPHATE Solution for injection A

PHOSPHOLIPIDS OF SWINE LUNG Endotracheal suspension C**

FOSFOMYCIN Capsule C

FOSFOMYCIN Capsule (granules) C

FOSFOMYCIN Solution for injection A

FOSFOMYCIN Oral suspension C

FOSFOMYCIN CALCIUM Oral granules for solution A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

FOSFOMYCIN TROMETAMOL (TROMETHAMINE) Oral granules for solution A

FOSFOMYCIN TROMETAMOL (TROMETHAMINE) Tablet C

FOSFOMYCIN TROMETAMOL (TROMETHAMINE) Granules for oral suspension C

FOSINOPRIL Tablet C

FULVESTRANT Solution for injection A

FORMOTEROL FUMARATE Inhalation powder C*

TENOFOVIR DISOPROXIL FUMARATE Tablet C

FERROUS FUMARATE Extended-release capsule A

FERROUS FUMARATE Oral suspension A

FERROUS FUMARATE Tablet A

FERROUS FUMARATE / FOLIC ACID Tablet A/B

HYDROGENATED CLEMASTINE FUMARATE Solution for injection A

FURAZOLIDONE Oral suspension C

FURAZOLIDONE Tablet C

FURAZOLIDONE / KAOLIN / PECTIN / HOMATROPINE Oral suspension C/A/A/A

FURAZOLIDONE / PECTIN / KAOLIN Oral suspension C/A/A

MOMETASONE FUROATE Nasal suspension A

MOMETASONE FUROATE Ointment A

FUROSEMIDE Solution for injection A

FUROSEMIDE Oral solution A

FUROSEMIDE Tablet C

FUSIDATE SODIUM Cream A

FUSIDATE SODIUM Tablet C

GABAPENTIN Capsule C

GABAPENTIN Tablet C

GABAPENTIN / MELOXICAM Tablet C/C

GABAPENTIN / TRAMADOL Capsule C/C

GALANTAMINE HYDROBROMIDE Extended-release capsule C

GALANTAMINE HYDROBROMIDE Solution A

GALANTAMINE HYDROBROMIDE Tablet C

GANCICLOVIR Capsule C

GANCICLOVIR Solution for injection A

GANIRELIX Solution for injection A

GATIFLOXACIN Tablet C

GATIFLOXACIN SESQUIHYDRATE Ophthalmic solution A

GEFITINIB Tablet C*

GELATIN Solution for injection A

GEMCITABINE Solution for injection A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

GEMFIBROZIL Tablet C

GEMIFLOXACIN Tablet C

GENTAMICIN Cream A

GENTAMICIN Solution for injection A

GENTAMICIN Ophthalmic solution A

GENTAMICIN Ointment A

GENTAMICIN-COLLAGEN Implant A

GENTAMICIN BETAMETHASONE VALERATE Cream A

GESTRINONE Capsule C

GLATIRAMER Solution for injection C*

GLIBENCLAMIDE Tablet C

GLIBENCLAMIDE / METFORMIN Tablet C/C

GLYCERIN Suppository A

GLYCEROL Ophthalmic solution A

GLICLAZIDE Tablet C

GLICLAZIDE Extended-release tablet C

GLICOFOSFOPEPTICAL Capsule A

GLIMEPIRIDE Tablet C

GLIMEPIRIDE / METFORMIN Tablet C/C

GLIPIZIDE Tablet C

GLUCAGON Solution for injection A

GLUCOSE Solution for injection A

ANHYDROUS GLUCOSE / TRISODIUM CITRATE DIHYDRATE / POTASSIUM CHLORIDE / SODIUM Oral powder A/A/A/A CHLORIDE

GLUCOSAMINE SULFATE Capsule C

GLUCOSAMINE SULFATE Oral granules for solution A

GLUCOSAMINE / ASCORBIC ACID / MANGANESE Soft gelatin capsules C/A/A/A SULFATE / CHONDROITIN

GLUCOSAMINE / MELOXICAM Powder for oral solution A/A

GLUCOSAMINE / CHONDROITIN SULFATE Capsule C/A

GLUCOSAMINE / CHONDROITIN SULFATE Powder for oral solution A/A

HUMAN POSTMENOPAUSAL GONADOTROPHINS Solution for injection A

(NON-RECOMBINANT) CHORIOGONADOTROPIN Solution for injection A

GOSERELIN Extended-release implant C

GRANISETRON Solution for injection A

GRANISETRON Oral solution A

GRANISETRON Coated tablet C

GRISEOFULVIN Oral suspension C

GRISEOFULVIN Tablet C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

GUAIFENESIN Syrup A

GUAIFENESIN Extended-release tablet C

GUAIFENESIN / OXOLAMINE CITRATE Syrup A/A

GUAIFENESIN / OXOLAMINE CITRATE Solution A/A

GUAIFENESIN / SULFAMETHOXAZOLE / TRIMETHOPRIM Oral suspension B/C/C

HALOBETASOL Skin ointment A

HALOPERIDOL Solution for injection A

HALOPERIDOL Oral solution A

HALOPERIDOL Tablet C

HALOPERIDOL DECANOATE Capsule C

HALOTHANE Liquid A

ALISKIREN HEMIFUMARATE Tablet C

ALISKIREN HEMIFUMARATE / HYDROCHLOROTHIAZIDE Tablet C/C

HEPARIN Solution for injection A

HETASTARCH Solution for injection A

SODIUM HYALURONATE Ophthalmic solution A

SODIUM HYALURONATE Solution for injection A

SODIUM HYALURONATE / OXYMETAZOLINE Ophthalmic solution A/A

HYALURONIDASE Solution for injection A

HYALURONIDASE Ophthalmic solution A

HYDRALAZINE Solution for injection A

HYDRALAZINE Tablet C

HYDRALAZINE Coated tablet C

HYDROCHLOROTHIAZIDE Tablet C

HYDROCHLOROTHIAZIDE / QUINAPRIL Coated tablet C/C

HYDROCHLOROTHIAZIDE / RAMIPRIL Tablet C/C

HYDROCHLOROTHIAZIDE / VALSARTAN Tablet C/C

HYDROCORTISONE Lotion A

HYDROCORTISONE Solution for injection A

HYDROCORTISONE Tablet C

HYDROCORTISONE 17 BUTYRATE Cream A

HYDROCORTISONE / DIIODOHYDROXYQUINOLINE Cream A/A

HYDROCORTISONE / NEOMYCIN / POLYMYXIN B Otic suspension A/A/A

HYDROMORPHONE Tablet C

HYDROQUINONE Cream A

HIDROSMIN Capsule A

HYDROTALCITE Oral suspension A

HYDROTALCITE Chewable tablet A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

HYDROXYCARBAMIDE Capsule C*

HYDROXYZINE Syrup A

HYDROXYZINE Coated tablet C

HYDROXYCHLOROQUINE SULFATE Tablet C

HYDROXYCOBALAMIN (sic) / METAMIZOLE / Solution for injection A/A/A/A PYRIDOXINE / THIAMINE

HYDROXYETHYL STARCH Solution for injection A

HYDROXYPROGESTERONE CAPROATE Oily solution for injection C

HYDROXYZINE HYDROCHLORIDE OR CITRATE Tablet B

HYDROXYZINE PAMOATE Tablet C

HYDROXYZINE HYDROCHLORIDE OR CITRATE Soft gelatin capsule B

HYDROXYZINE PAMOATE Soft gelatin capsule C

HYDROXOCOBALAMIN Solution for injection A

HYDROXOCOBALAMIN / LIDOCAINE / PYRIDOXINE / Solution for injection A/A/A/A THIAMINE

CARBONYL IRON / FOLIC ACID Capsule A/B

IRON DEXTRAN Solution for injection A

ELEMENTAL IRON Solution for injection A

HYOSCINE BUTYL BROMIDE Coated tablet A

HYOSCINE BUTYL BROMIDE / IBUPROFEN Tablet A/C

HYOSCINE BUTYL BROMIDE / METAMIZOLE Oral solution A/A

HYOSCINE BUTYL BROMIDE / METAMIZOLE Coated tablet A/C

HYOSCINE BUTYL BROMIDE / PARACETAMOL Tablet A/B (ACETAMINOPHEN)

HYOSCINE BUTYL BROMIDE / PARACETAMOL Coated tablet A/B (ACETAMINOPHEN)

HYOSCINE / KETOROLAC Tablet A/C

HYOSCINE / PARACETAMOL (ACETAMINOPHEN) Oral solution A/A

HYPROMELLOSE Ophthalmic solution A

HYPROMELLOSE / NAPHAZOLINE Ophthalmic solution A/A

HOMATROPINE Ophthalmic solution A

IBUPROFEN Capsule C

IBUPROFEN Oral solution A

IBUPROFEN Oral suspension C

IBUPROFEN Tablet C

IBUPROFEN Chewable tablet C

IBUPROFEN Coated tablet C

IBUPROFEN ARGINATE Oral granules for solution A

IBUPROFEN ARGINATE Solution A

IBUPROFEN ARGINATE Coated tablet C

IBUPROFEN / CAFFEINE Tablet C/A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

IBUPROFEN / MENTHOL Topical gel A/A

IBUPROFEN / METHOCARBAMOL Tablet C/C

IBUPROFEN / PAMABROM / PYRILAMINE Capsule C/C/C

IBUPROFEN / PARACETAMOL (ACETAMINOPHEN) Tablet C/B

IDARUBICIN Solution for injection A

IDEBENONE Coated tablet C

IDOXURIDINE Ophthalmic solution A

IDOXURIDINE Ointment A

IFOSFAMIDE Solution for injection A

ILOPROST Inhalation solution A

IMATINIB Tablet C*

IMIPENEM / CILASTATIN Solution for injection A/A

IMIPRAMINE Coated tablet C

IMIQUIMOD Cream A

INDAPAMIDE Extended-release tablet C

INDAPAMIDE / PERINDOPRIL Tablet C/C

INDINAVIR Capsule C

INDOBUFEN Tablet C

INDOMETACIN Capsule C

INDOMETACIN Extended-release capsule C

INDOMETACIN Solution for injection A

INDOMETACIN Suppository C

INDOMETACIN / METHOCARBAMOL Capsule C/C

INOSINE Syrup A

INOSINE Tablet A

POVIDONE-IODINE Ointment A

ISOPROPAMIDE IODIDE / TRIFLUOPERAZINE Coated tablet C/C

TIBEZONIUM IODIDE Buccal solution A

IPRATROPIUM Suspension spray C*

IPRATROPIUM / SALBUTAMOL Suspension spray C*

IPRATROPIUM / SALBUTAMOL Suspension for nebulization A/A

IRBESARTAN Tablet C

IRBESARTAN / HYDROCHLOROTHIAZIDE Tablet C/C

IRINOTECAN Solution for injection A

ISOCONAZOLE Cream A

ISOFLURANE Liquid A

ISONIAZID Tablet C

ISONIAZID / ETHAMBUTOL Coated tablet C/C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

ISONIAZID / RIFAMPICIN Tablet and capsule C/C

ISOPRENALINE (ISOPROTERENOL) Solution for injection A

ISOSORBIDE DINITRATE Solution for injection A

ISOSORBIDE DINITRATE Tablet C

ISOSORBIDE DINITRATE Extended-release tablet C

ISOSORBIDE DINITRATE Sublingual tablet C

ISOSORBIDE MONONITRATE Tablet C

ISOSORBIDE 5-MONONITRATE Extended-release capsule C

ISOTHIPENDYL Skin gel A

ISOTHIPENDYL Syrup A

ISOTHIPENDYL Coated tablet C

ISOTRETINOIN Capsule B

ISOTRETINOIN Skin cream A

ISOTRETINOIN Skin gel A

ISRADIPINE Solution for injection A

ISRADIPINE Tablet C

ITOPRIDE Tablet C

ITRACONAZOLE Capsule C

ITRACONAZOLE Oral solution A

ITRACONAZOLE Tablet C

ITRACONAZOLE / SECNIDAZOLE Capsule C/C

IVABRADINE Tablet C

IVERMECTIN Tablet C

KANAMYCIN Solution for injection A

KETAMINE Solution for injection A

KETANSERIN Gel A

KETANSERIN Insert A

KETANSERIN Solution for injection A

KETANSERIN Tablet C

KETOCONAZOLE Cream A

KETOCONAZOLE Gel A

KETOCONAZOLE Skin lotion (shampoo) A

KETOCONAZOLE Insert A

KETOCONAZOLE Powder A

KETOCONAZOLE Suspension C

KETOCONAZOLE Tablet C

KETOPROFEN Capsule C

KETOPROFEN Extended-release capsule C

KETOPROFEN Gel A

KETOPROFEN Oral granules A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

KETOPROFEN Solution for injection A

KETOPROFEN Suppository C

KETOPROFEN Tablet C

KETOPROFEN Extended-release tablet C

KETOPROFEN SODIUM Oral solution A

KETOPROFEN SODIUM Coated tablet C

KETOPROFEN SODIUM / PARACETAMOL Oral suspension C/B (ACETAMINOPHEN)

KETOPROFEN SODIUM / PARACETAMOL Tablet C/B (ACETAMINOPHEN)

KETOROLAC TROMETHAMINE Capsule C

KETOROLAC TROMETHAMINE Soft gelatin capsule C

KETOROLAC TROMETHAMINE Skin gel A

KETOROLAC TROMETHAMINE Solution for injection A

KETOROLAC TROMETHAMINE Ophthalmic solution A

KETOROLAC TROMETHAMINE Tablet C

KETOROLAC TROMETHAMINE Sublingual tablet C

KETOROLAC TROMETHAMINE / TRAMADOL Capsule C/C

KETOROLAC TROMETHAMINE / TRAMADOL Solution for injection A/A

KETOROLAC TROMETHAMINE / TRAMADOL Oral solution A/A

KETOROLAC TROMETHAMINE / TRAMADOL Tablet C/C

KETOTIFEN Oral solution A

KETOTIFEN FUMARATE Syrup A

KETOTIFEN FUMARATE Ophthalmic solution A

KETOTIFEN FUMARATE Tablet C

KETOTIFEN FUMARATE Extended-release tablet C

LACIDIPINE Tablet C

LACOSAMIDE Tablet C

CALCIUM LACTOGLUCONATE Solution for injection A

CALCIUM LACTOGLUCONATE Effervescent tablet A

LACTULOSE Syrup A

LACTULOSE / PARAFFIN Skin gel A/A

LAMIVUDINE Oral solution A

LAMIVUDINE Tablet C

LAMIVUDINE / ZIDOVUDINE Tablet C/C

LAMOTRIGINE Tablet C

LAMOTRIGINE Dispersible tablet C

Coated extended-release LAMOTRIGINE C tablet

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

LANATOSIDE C Solution for injection A

LANOLIN / MINERAL OIL Ointment A/A

LANSOPRAZOLE Extended-release capsule C

LANSOPRAZOLE Powder for oral suspension C

LANSOPRAZOLE Tablet C

LATANOPROST Ophthalmic solution A

LATANOPROST / TIMOLOL Ophthalmic solution A/A

VEGETABLE LECITHIN Cream A

LEFLUNOMIDE Tablet C

LERCANIDIPINE Tablet C

LETROZOLE Coated tablet C*

LEUPRORELIN (>3.75 mg) Suspension for injection C in patients

LEUPRORELIN (3.75 mg) Suspension for injection C in healthy subjects

LEVAMISOLE HYDROCHLORIDE Tablet C

LEVETIRACETAM Solution for injection A

LEVETIRACETAM Oral solution A

LEVETIRACETAM Tablet C

LEVOCARNITINE Capsule A

LEVOCARNITINE Solution for injection A

LEVOCARNITINE Chewable tablet A

LEVOCETIRIZINE Tablet C

LEVODOPA / CARBIDOPA Tablet C/C

LEVODROPROPIZINE Syrup A

LEVODROPROPIZINE Oral solution A

LEVODROPROPIZINE Tablet C

LEVOFLOXACIN Solution for injection A

LEVOFLOXACIN Tablet C

LEVOMEPROMAZINE MALEATE Tablet C

LEVONORGESTREL Intrauterine powder C

LEVONORGESTREL Tablet C

LEVONORGESTREL Coated tablet C

LEVONORGESTREL / ETHINYLESTRADIOL Coated tablet C/C

LEVOPROMAZINE Tablet C

LEVOSIMENDAN Solution for injection A

LEVOSULPIRIDE Solution for injection A

LEVOSULPIRIDE Tablet C

LEVOTHYROXINE Tablet C*

LEVOTHYROXINE SODIUM / LIOTHYRONINE Tablet C*

LIDAMIDINE HYDROCHLORIDE Tablet C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

LIDOCAINE Gel A

LIDOCAINE Skin solution A

LIDOCAINE Solution for injection A

LIDOCAINE Ointment A

LIDOCAINE / EPINEPHRINE Solution for injection A/A

LIDOCAINE / HYDROCORTISONE Suppository A/A

LIDOCAINE / HYDROCORTISONE Ointment A/A

LIDOCAINE / NEOMYCIN Otic solution A/A

LIDOCAINE / PRILOCAINE Topical cream A/A

LIDOCAINE / TRIBENOSIDE Rectal cream A/A

LYMECYCLINE Capsule C

LINCOMYCIN Capsule C

LINCOMYCIN Syrup A

LINCOMYCIN Solution for injection A

LYNESTRENOL Tablet C

LINEZOLID Suspension C

LINEZOLID Tablet C

LINEZOLID Solution for injection A

LIOTHYRONINE Tablet C*

INTRAVENOUS LIPIDS Emulsion for injection A

LISINOPRIL Tablet C

LISINOPRIL / HYDROCHLOROTHIAZIDE Tablet C/C

LITHIUM Tablet C

LODOXAMIDE Ophthalmic solution A

LOMEFLOXACIN Tablet C

LOMIFILINE / DIHYDROERGOCRISTINE MESYLATE Tablet C/C

LOPERAMIDE Coated tablet C

LOPINAVIR / RITONAVIR Capsule C/C

LOPINAVIR / RITONAVIR Oral solution A/A

LOPINAVIR / RITONAVIR (Coated) tablet C/C

LORATADINE Soft gelatin capsule C

LORATADINE Syrup A

LORATADINE Oral solution A

LORATADINE Suspension C

LORATADINE Dispersible tablet C

LORATADINE Effervescent tablet A

LORATADINE Coated tablet C

LORATADINE Capsule C This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

LORAZEPAM Extended-release capsule C

LORAZEPAM Tablet C

LORAZEPAM Sublingual tablet C

L-ORNITHINE / L-ASPARTATE Oral granules for solution A/A

L-ORNITHINE / L-ASPARTATE Solution for injection A/A

LOSARTAN Tablet C

LOSARTAN POTASSIUM Coated tablet C

LOSARTAN / HYDROCHLOROTHIAZIDE Coated tablet C/C

LOVASTATIN Tablet C

LOXOPROFEN Tablet C

TOLTERIDONE (sic) L-TARTRATE Tablet C

LUTROPIN ALPHA Solution for injection A

MAGNESIUM Oral suspension A

MAGNESIUM Tablet A

MAGNESIUM SULFATE Solution for injection A

BROMPHENIRAMINE MALEATE Tablet B

CHLORPHENAMINE MALEATE / PARAMETHASONE Suspension B/C ACETATE

CHLORPHENAMINE MALEATE / PARAMETHASONE Tablet B/C ACETATE

CHLORPHENAMINE MALEATE / SALICYLAMIDE Capsule B/B

DEXBROMPHENIRAMINE MALEATE / PHENYLEPHRINE Tablet B/A HYDROCHLORIDE

MANGANESE Solution for injection A

MANNITOL Solution for injection A

MAPROTILINE Coated tablet C

MARAVIROC Tablet C

MAZINDOL Extended-release capsule C

MAZINDOL Tablet C

MEBENDAZOLE Oral suspension B

MEBENDAZOLE Tablet B

MEBENDAZOLE / QUINFAMIDE Suspension B/A

MEBENDAZOLE / QUINFAMIDE Tablet B/A

MEBENDAZOLE / TINIDAZOLE Tablet B/C

MEBEVERINE Oral suspension C

MEBEVERINE HYDROCHLORIDE Capsule C

MECLIZINE (MECLOZINE) Chewing gum A

MECLIZINE (MECLOZINE) Tablet B

MECLIZINE / PYRIDOXINE Syrup A/A

MECLIZINE / PYRIDOXINE Solution for injection A/A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

MECLIZINE / PYRIDOXINE Oral solution A/A

MECLIZINE / PYRIDOXINE Tablet B/A

MECLIZINE / PYRIDOXINE / LIDOCAINE Solution for injection A/A/A

MEDROXYPROGESTERONE Suspension for injection C

MEDROXYPROGESTERONE Tablet C

MEDROXYPROGESTERONE / ESTRADIOL CIPIONATE Suspension for injection C/C

MEGESTROL Tablet C

MEGLUMINE ANTIMONATE Solution for injection A

MELATONIN Tablet B

MELATONIN Modified-release tablet B

MELATONIN Sublingual tablet B

MELPHALAN Tablet C*

MELOXICAM Solution for injection A

MELOXICAM Ophthalmic solution A

MELOXICAM Oral suspension C

MELOXICAM Tablet C

MELOXICAM / METHOCARBAMOL Capsule C/C

MEMANTINE Tablet C

MENTHOL / METHYL SALICYLATE Topical patch A/A

MEPYRAMINE Oral solution A

Solution for injection (local MEPIVACAINE A and/or regional infiltration)

MEPREDNISONE Tablet C

MERCAPTOPURINE Tablet C*

MEROPENEM Solution for injection A

MESALAZINE Rectal foam A

MESALAZINE Oral granules B

MESALAZINE Suppository B

MESALAZINE Rectal suspension B

MESALAZINE Tablet B

MESALAZINE Coated tablet B

RASAGILINE MESYLATE Tablet C

MESNA Solution for injection A

MESTEROLONE Tablet C

MESTRANOL Tablet C

MESTRANOL / NORETHISTERONE Tablet C/C

METHADONE Solution for injection A

METHADONE Oral solution A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

METHADONE Dispersible tablet B

METADOXINE Tablet C

METAMIZOLE SODIUM Syrup A

METAMIZOLE SODIUM Solution for injection A

METAMIZOLE SODIUM Oral solution A

METAMIZOLE SODIUM Suppository C

METAMIZOLE SODIUM Tablet C

METAMIZOLE SODIUM / CHLORPHENAMINE / Solution A/A/A/A GUAIFENESIN / LIDOCAINE

METAMIZOLE SODIUM / PRAMIVERINE Coated tablet C/C HYDROCHLORIDE

METHENAMINE Tablet C

METENOLONE Solution for injection A

METFORMIN Powder for oral solution A

METFORMIN Tablet C

METFORMIN Extended-release tablet C

METHYLDOPA (L-ALPHAMETHYLDOPA) Tablet C

METHYLERGOMETRINE HYDROGEN MALEATE Coated tablet C

METHYLERGOMETRINE MALEATE Solution for injection A

METHYLPHENIDATE Tablet C

Coated extended-release METHYLPHENIDATE C tablet

METHYLPHENIDATE Granules C

METHYLPHENIDATE Oral dispersible tablet C

METHYLPREDNISOLONE ACETATE Suspension for injection C

METHYLPREDNISOLONE SODIUM SUCCINATE Solution for injection A

METHISOPRINOL Tablet C

METHOCARBAMOL Tablet C

METHOCARBAMOL / PARACETAMOL Tablet C/B (ACETAMINOPHEN)

METOCLOPRAMIDE Solution for injection A

METOCLOPRAMIDE Oral solution A

METOCLOPRAMIDE Tablet C

METOCLOPRAMIDE Extended-release tablet C

METOCLOPRAMIDE / ONDANSETRON Tablet C/C

METOPROLOL Coated tablet B***

Coated extended-release METOPROLOL C tablet

METOPROLOL TARTRATE Solution for injection A

METOPROLOL SUCCINATE / HYDROCHLOROTHIAZIDE Tablet C/C

METHOTREXATE Solution for injection A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

METHOTREXATE Tablet C

METHOXALEN Tablet C

METRONIDAZOLE Cream A

METRONIDAZOLE Skin gel A

METRONIDAZOLE Vaginal tablet or insert A

METRONIDAZOLE Solution for injection A

METRONIDAZOLE Oral suspension C

METRONIDAZOLE Tablet C

METRONIDAZOLE / DIIODOHYDROXYQUINOLINE Oral suspension C/A

METRONIDAZOLE / DIIODOHYDROXYQUINOLINE Tablet C/A

METRONIDAZOLE / MICONAZOLE Insert A/A

METRONIDAZOLE / NIFUROXAZIDE Capsule C/A

METRONIDAZOLE / NIFUROXAZIDE Oral suspension C/A

METRONIDAZOLE / NYSTATIN Insert A/A

MEXILETINE HYDROCHLORIDE Capsule C

MIANSERIN Tablet C

MYCOPHENOLATE MOFETIL Capsule C

MYCOPHENOLATE MOFETIL Solution for injection A

MYCOPHENOLATE MOFETIL Tablet C

MICONAZOLE Cream A

MICONAZOLE Vaginal cream A

MICONAZOLE Oral gel A

MICONAZOLE Insert A

MICONAZOLE Cutaneous powder A

MICONAZOLE Skin solution A

MIDAZOLAM Solution for injection A

MIDAZOLAM Tablet C

MIFEPRISTONE Tablet C

MIGLITOL Tablet B***

MILRINONE LACTATE Solution for injection A

MILTEFOSINE Capsule B

MINOCYCLINE Capsule C

MINOCYCLINE Coated tablet C

MINOXIDIL Solution A

MIRTAZAPINE Solution for injection A

MIRTAZAPINE Tablet C

MIRTAZAPINE Dispersible tablet C

MISOPROSTOL Insert A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

MISOPROSTOL Tablet C

MITOMYCIN Solution for injection A

MITOXANTRONE Solution for injection A

MOCLOBEMIDE Tablet C

MODAFINIL Tablet C

MOMETASONE Cream A

MOMETASONE Topical cream A

MOMETASONE Skin solution A

MOMETASONE Dermal suspension A

MOMETASONE Ointment A

MONTELUKAST Oral granules C

MONTELUKAST Tablet C

MONTELUKAST Chewable tablet C

MONTELUKAST / LORATADINE Capsule C/C

MORPHINE Extended-release capsule C

MORPHINE Solution for injection A

MORPHINE Tablet C

MORPHINE Extended-release tablet C

MOSAPRIDE Oral suspension C

MOSAPRIDE Tablet C

MOXIFLOXACIN Solution for injection A

MOXIFLOXACIN Ophthalmic solution A

MOXIFLOXACIN Tablet C

MUPIROCIN Topical ointment A

NABILONE Capsule C

NABUMETONE Tablet C

NADROPARIN Solution for injection C*

NAPHAZOLINE Nasal solution A

NAPHAZOLINE Ophthalmic solution A

NAPHAZOLINE / ZINC Ophthalmic solution A/A

NAFTAZONE Tablet C

NALBUPHINE Solution for injection A

NALOXONE Solution for injection A

NAPROXEN Capsule C

NAPROXEN Gel A

NAPROXEN Suspension C

NAPROXEN Tablet C

NAPROXEN SODIUM Suppository C

NAPROXEN SODIUM Tablet C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

NAPROXEN SODIUM / PARACETAMOL Suppository C/B (ACETAMINOPHEN)

NAPROXEN SODIUM / PARACETAMOL Oral suspension C/B (ACETAMINOPHEN)

NAPROXEN / CARISOPRODOL Tablet C/C

NAPROXEN / PARACETAMOL (ACETAMINOPHEN) Tablet C/B

NARATRIPTAN Tablet C

NATEGLINIDE Coated tablet C

NEBIVOLOL Tablet C

NEOMYCIN Capsule A

NEOMYCIN SULFATE Tablet A

NEOMYCIN / NYSTATIN / POLYMYXIN B Vaginal capsule A/A/A

NEOMYCIN / POLYMYXIN B / FLUOCINOLONE Otic suspension or solution A/A/A ACETONIDE

NEOMYCIN / POLYMYXIN B / FLUOCINOLONE Otic solution A/A/A/A ACETONIDE / LIDOCAINE

NEOMYCIN / POLYMYXIN B / BACITRACIN Ophthalmic ointment A/A/A

NEOMYCIN / POLYMYXIN B / GRAMICIDIN Ophthalmic solution A/A/A

NEOMYCIN / RETINOL Skin ointment A/A

NEOSTIGMINE Solution for injection A

NEOSTIGMINE BROMIDE Tablet B

NEPAFENAC Ophthalmic suspension A

NESIRITIDE Solution for injection A

NETILMICIN Eye drops A

NEVIRAPINE Oral suspension C

NEVIRAPINE Tablet C

NIACIN Extended-release tablet C

NICOTINE Topical patch B

NICOTINE Solution A

NIFEDIPINE Soft gelatin capsule C

NIFEDIPINE Extended-release tablet C

NIFURATEL Capsule C

NIFUROXAZIDE Capsule A

NIFUROXAZIDE Oral suspension A

NIFUROXAZIDE Tablet A

NILUTAMIDE Tablet C*

NIMESULIDE Soft gelatin capsule C

NIMESULIDE Gel A

NIMESULIDE Oral granules for solution C

NIMESULIDE Suppository C This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

NIMESULIDE Oral suspension C

NIMESULIDE Tablet C

NIMESULIDE Dispersible tablet C

NIMODIPINE Solution for injection A

NIMODIPINE Tablet C

NYSTATIN Vaginal tablet or insert A

NYSTATIN Powder for oral suspension B

NYSTATIN / BENZALKONIUM CHLORIDE / Insert A/A/A DIIODOHYDROXYQUINOLINE

NYSTATIN / TRIAMCINOLONE Cream A/A

NITAZOXANIDE Oral granules C

NITAZOXANIDE Insert A

NITAZOXANIDE Oral suspension C

NITAZOXANIDE Tablet C

NITAZOXANIDE Dispersible tablet C

NITROFURAL Insert A

NITROFURAL Ointment A

NITROFURANTOIN Capsule C

NITROFURANTOIN Oral suspension C

SODIUM NITROPRUSSIDE Solution for injection A

NOMEGESTROL Tablet C

NOREPINEPHRINE Solution for injection A

NORETHINDRONE (NORETHISTERONE) / Tablet C/C ETHYNILESTRANDIOL (sic)

NORETHISTERONE (NORETHINDRONE) Oily solution for injection C

NORETHISTERONE (NORETHINDRONE) Tablet C

NORETHISTERONE (NORETHINDRONE) ENANTATE / Solution for injection C/C ESTRADIOL VALERATE

NORETHISTERONE (NORETHINDRONE) / Coated tablet C/C ETHINYLESTRADIOL

NORFENEFRINE Oral solution A

NORFLOXACIN Oral solution A

NORFLOXACIN Tablet C

PARENTERAL NUTRITION Emulsion for injection A

OCTREOTIDE Solution for injection A

OCTREOTIDE Suspension for injection C

OFLOXACIN Solution for injection A

OFLOXACIN Ophthalmic solution A

OFLOXACIN Tablet C

OLANZAPINE Solution for injection A

OLANZAPINE Tablet C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

OLANZAPINE Dispersible tablet C

OLANZAPINE / FLUOXETINE Capsule C/C

INTRAVENOUS TRACE METALS Solution for injection A

OLMESARTAN MEDOXOMIL Tablet C

OLMESARTAN / AMLODIPINE Tablet C/C

OLOPATADINE Ophthalmic solution A

OMEPRAZOLE Capsule C

OMEPRAZOLE Solution for injection A

OMEPRAZOLE Oral suspension C

OMEPRAZOLE Powder C

OMEPRAZOLE MAGNESIUM Film-coated tablet C

OMEPRAZOLE MAGNESIUM Delayed-release granules C

ONDANSETRON Syrup A

ONDANSETRON Solution for injection A

ONDANSETRON Suppository C

ONDANSETRON Tablet C

ORCIPRENALINE Solution for injection A

ORCIPRENALINE Tablet C

ORPHENADRINE Solution for injection A

ORLISTAT Capsule A

ORLISTAT Tablet A

OSELTAMIVIR PHOSPHATE Capsule C

OSELTAMIVIR PHOSPHATE Oral suspension C

OUABAIN Solution for injection A

OXACILLIN Solution for injection A

OXALIPLATIN Solution for injection A

OXCARBAZEPINE Oral suspension C

OXCARBAZEPINE Tablet C

OXCARBAZEPINE Coated tablet C

OXELADIN / AMBROXOL Syrup A/A

OXERUTINS Skin gel A

OXYBUTYNIN Extended-release tablet C

OXYBUTYNIN HYDROCHLORIDE Syrup A

OXYCODONE Capsule C

OXYCODONE Extended-release tablet C

OXYCODONE / PARACETAMOL (ACETAMINOPHEN) Tablet C/B

OXICONAZOLE Cream A

ZINC OXIDE Cream A

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

ZINC OXIDE Paste A

OXYMETAZOLINE Nasal solution A

OXYMETAZOLINE Nasal suspension A

OXYMETAZOLINE / DEXPANTHENOL Nasal solution A/A

OXYMETAZOLINE / SODIUM HYALURONATE Ophthalmic solution A/A

OXYMETHOLONE Tablet C

OXYTETRACYCLINE Capsule C

OXYTETRACYCLINE Ointment A

OXYTETRACYCLINE Solution for injection A

OXYTETRACYCLINE Troche C

OXYTETRACYCLINE / POLYMYXIN B Skin ointment A/A

OXYTETRACYCLINE / POLYMYXIN B Ointment A/A

OXYTOCIN Solution for injection A

OXOLAMINE Syrup A

PACLITAXEL Solution for injection A

PALONOSETRON Solution for injection A

PAMABROM / PARACETAMOL (ACETAMINOPHEN) / Tablet C/B/C PYRILAMINE

PANCREATIN Film-coated capsule or tablet A

PANCREATIN / DRY EXTRACT OF OX BILE / Tablet A/A/A DIMETHYLPOLYSILOXANE

PANCURONIUM Solution for injection A

PANTOPRAZOLE Oral granules C

PANTOPRAZOLE Solution for injection A

PANTOPRAZOLE Tablet C

PANTOPRAZOLE Coated tablet C

PARACETAMOL (ACETAMINOPHEN) Capsule B

PARACETAMOL (ACETAMINOPHEN) Oral granules for solution A

PARACETAMOL (ACETAMINOPHEN) Syrup A

PARACETAMOL (ACETAMINOPHEN) Solution for injection A

PARACETAMOL (ACETAMINOPHEN) Oral solution A

PARACETAMOL (ACETAMINOPHEN) Suppository B

PARACETAMOL (ACETAMINOPHEN) Oral suspension B

PARACETAMOL (ACETAMINOPHEN) Tablet B

Dispersible or effervescent PARACETAMOL (ACETAMINOPHEN) A tablet

PARACETAMOL (ACETAMINOPHEN) Chewable tablet B

PARACETAMOL (ACETAMINOPHEN) Coated tablet B

PARACETAMOL (ACETAMINOPHEN) / CHLORPROPHENPYRIDAMINE MALEATE / Tablet B/B/A PHENYLEPHRINE HYDROCHLORIDE

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

PARACETAMOL (ACETAMINOPHEN) / PHENYLEPHRINE BITARTRATE / CHLORPHENAMINE MALEATE / Tablet B/A/B/A ASCORBIC ACID

PARACETAMOL (ACETAMINOPHEN) / CAFFEINE Tablet B/A

PARACETAMOL (ACETAMINOPHEN) / CAFFEINE / Effervescent tablet A/A/A CALCIUM CARBONATE

PARACETAMOL (ACETAMINOPHEN) / CAFFEINE / Tablet B/A/C PYRILAMINE

PARACETAMOL (ACETAMINOPHEN) / CARBINOXAMINE Tablet B/B

PARACETAMOL (ACETAMINOPHEN) / PHENYLEPHRINE HYDROCHLORIDE / DEXTROMETHORPHAN Syrup A/A/A HYDROBROMIDE

PARACETAMOL (ACETAMINOPHEN) / PHENYLEPHRINE HYDROCHLORIDE / DIPHENHYDRAMINE Syrup A/A/A HYDROBROMIDE

PARACETAMOL (ACETAMINOPHEN) / PHENYLEPHRINE Granules A/A/A HYDROCHLORIDE / CHLORPHENAMINE MALEATE

PARACETAMOL (ACETAMINOPHEN) / PHENYLEPHRINE HYDROCHLORIDE / CHLORPHENAMINE MALEATE / Oral solution A/A/A/A DEXTROMETHORPHAN HYDROBROMIDE

PARACETAMOL (ACETAMINOPHEN) / DIPHENHYDRAMINE / PHENYLEPHRINE Oral granules for solution A/A/A HYDROCHLORIDE

PARACETAMOL (ACETAMINOPHEN) / PHENYLEPHRINE / Tablet B/A/B CHLORPHENAMINE

PARACETAMOL (ACETAMINOPHEN) / PHENYLEPHRINE / Tablet B/A/B CARBINOXAMINE MALEATE

PARACETAMOL (ACETAMINOPHEN) / TOLPERISONE Capsule B/C

PARACETAMOL (ACETAMINOPHEN) / TRAMADOL Oral solution A/A

PARACETAMOL (ACETAMINOPHEN) / TRAMADOL Tablet B/C

PARAMETHASONE ACETATE Oral suspension C

PARAMETHASONE ACETATE Tablet C

PARECOXIB Solution for injection A

PARECOXIB Tablet C

PARGEVERINE Tablet C

PARICALCITOL Capsule C

PARICALCITOL Solution for injection A

PARNAPARIN Solution for injection C*

PAROXETINE Oral suspension C

PAROXETINE Tablet C

PAROXETINE Extended-release tablet C

PEMETREXED Solution for injection A

PENFLURIDOL Tablet C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

PENICILLAMINE Tablet C

PENICILLIN V POTASSIUM Coated tablet C

PENTOSAN POLYSULFATE SODIUM Capsule A

PENTOXIFYLLINE Solution for injection A

PENTOXIFYLLINE Extended-release tablet C

PERPHENAZINE Solution for injection A

PERPHENAZINE Coated tablet C

PERFLUORODECALIN / Emulsion A/A PERFLUOROMETHYLCYCLOHEXYLPIPERIDINE

PERINDOPRIL Tablet C

PERMETHRIN Skin emulsion A

PERMETHRIN Skin solution A

PETHIDINE (MEPERIDINE) Solution for injection A

SODIUM PICOSULFATE Syrup A

SODIUM PICOSULFATE Oral solution A

SODIUM PICOSULFATE Tablet A

SODIUM PICOSULFATE Capsule A

PIKETOPROFEN Skin spray A

PIKETOPROFEN Topical cream A

PIKETOPROFEN Gel A

PILOCARPINE Ophthalmic solution A

PILOCARPINE Tablet C

PINAVERIUM Tablet A

PINAZEPAM Capsule C

PINDOLOL Tablet C

PIOGLITAZONE Tablet C

PIOGLITAZONE / GLIMEPIRIDE Tablet C/C

PIOGLITAZONE / METFORMIN Tablet C/C

PIPENZOLATE / SIMETHICONE Oral emulsion A/A

PIPERACILLIN / TAZOBACTAM Solution for injection A/A

PIPERIDOLATE HYDROCHLORIDE Coated tablet A

PIRACETAM Tablet C

PYRANTEL Oral suspension B

PYRANTEL Tablet B

PYRAZINAMIDE Tablet C

PYRIDOSTIGMINE Tablet C

PYRIDOSTIGMINE BROMIDE Extended-release tablet C

PYRIDOXINE Tablet A

PYRIMETHAMINE Tablet C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

PYRITINOL DIHYDROCHLORIDE MONOHYDRATE Coated tablet A

PYRITINOL DIHYDROCHLORIDE Oral suspension A

PYRITINOL DIHYDROCHLORIDE Coated tablet A

PIROXICAM Capsule or tablet C

PIROXICAM Gel A

PIROXICAM Solution for injection A

PIROXICAM Ophthalmic solution A

PIROXICAM Suppository C

PIROXICAM Effervescent tablet A

PIROXICAM Coated tablet C

PIZOTIFEN HYDROGEN MALEATE Coated tablet C

PSYLLIUM Powder A

PODOPHYLLIN Skin solution A

POLICOSANOL Tablet A

POLICRESULEN Cream A

POLICRESULEN Gel A

POLICRESULEN Insert A

POLICRESULEN Skin solution A

POLICRESULEN Vaginal solution A

POLIDOCANOL 600, LIDOCAINE HYDROCHLORIDE Gel A

POLIDOCANOL, LIDOCAINE HYDROCHLORIDE Skin solution A

CALCIUM POLYSTYRENE SULFONATE Oral suspension A

POLYETHYLENE GLYCOL Powder A

POLYETHYLENE GLYCOL Oral solution A

POLYGELINE Solution for injection A

POLYVITAMINS AND MINERALS Capsule A

POLYVITAMINS AND MINERALS Syrup A

POLYVITAMINS AND MINERALS Oral solution A

POLYVITAMINS AND MINERALS Tablet A

POLYVITAMINS AND MINERALS Coated tablet A

PORFIMER Solution for injection A

POTASSIUM SALTS Soluble tablet A

POTASSIUM CHLORIDE Solution for injection A

POTASSIUM CHLORIDE Extended-release tablet A

POTASSIUM CHLORIDE Effervescent tablet A

POTASSIUM CHLORIDE Coated tablet A

POTASSIUM GLUCONATE Powder for oral solution A

PRAMIPEXOLE Tablet C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

PRAMIVERINE Solution for injection A

PRANLUKAST Capsule C

PRANLUKAST Oral granules for solution C

PRANOPROFEN Ophthalmic solution A

PRASTERONE Capsule B

PRASTERONE Tablet B

PRASTERONE / TESTOSTERONE Oily solution for injection C/C

PRASUGREL Tablet C

PRAVASTATIN Tablet C

PRAZIQUANTEL Tablet C

PRAZOSIN Capsule or tablet C

PREDNICARBATE Cream A

PREDNICARBATE Skin solution A

PREDNISOLONE Ophthalmic solution A

PREDNISOLONE Oral solution A

PREDNISOLONE Ophthalmic suspension A

PREDNISOLONE Ophthalmic ointment A

PREDNISOLONE / SULFACETAMIDE Ophthalmic solution A/A

PREDNISOLONE / SULFACETAMIDE Ophthalmic suspension A/A

PREDNISOLONE / SULFACETAMIDE Ophthalmic ointment A/A

PREDNISOLONE / TOBRAMYCIN Ophthalmic suspension A/A

PREDNISOLONE / TOBRAMYCIN Ophthalmic ointment A/A

PREDNISONE Tablet C

PREGABALIN Capsule C

PREGABALIN Tablet C

PRILOCAINE / FELYPRESSIN Solution for injection A/A

PRIMAQUINE Tablet C

PRIMIDONE Oral suspension C

PRIMIDONE Tablet C

PROBENECID Tablet B

PROCAINE Solution for injection A

PROCARBAZINE Capsule or tablet C*

PROGESTERONE (Micronized) capsule C

PROGESTERONE Skin emulsion A

PROGESTERONE Gel (skin administration) A

PROGESTERONE Gel (vaginal administration) A

PROGESTERONE Oily solution for injection C

PROGESTERONE Suspension for injection C

PROGESTERONE Vaginal tablet A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

PROMEGESTONE Tablet C

PROMESTRIENE Capsule C

PROPAFENONE Tablet C

PROPAFENONE HYDROCHLORIDE Solution for injection A

PROPANIDID Solution for injection A

PROPYPHENAZONE / DROFENINE HYDROCHLORIDE Coated tablet C/A

PROPOFOL Emulsion for injection A

PROPRANOLOL Solution for injection A

PROPRANOLOL Tablet B***

PROTAMINE Solution for injection A

QUETIAPINE (healthy volunteers 25 mg) Tablet C

QUETIAPINE (healthy volunteers 50 mg) Extended-release tablet C

QUINAGOLIDE HYDROCHLORIDE Tablet B***

QUINAPRIL Coated tablet C

QUINFAMIDE Oral suspension A

QUINFAMIDE Tablet A

QUINFAMIDE Chewable tablet A

QUINFAMIDE / ALBENDAZOLE Suspension A/B

QUINFAMIDE / ALBENDAZOLE Tablet A/B

QUINIDINE Tablet C

QUINIDINE Coated tablet C

QUININE Tablet C

RABEPRAZOLE Solution for injection A

RABEPRAZOLE Tablet C

RACECADOTRIL Capsule A

RALOXIFENE Tablet C

RALTEGRAVIR POTASSIUM Tablet C

RALTITREXED Solution for injection A

RAMIPRIL Capsule C

RAMIPRIL Tablet C

STRONTIUM RANELATE Granules A

RANITIDINE Syrup A

RANITIDINE Solution for injection A

RANITIDINE Oral solution A

RANITIDINE Tablet C

RANITIDINE Effervescent tablet A

REBOXETINE Tablet C

REMIFENTANIL Solution for injection A

REPAGLINIDE Tablet C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

REPAGLINIDE / METFORMIN Tablet C/C

RIBAMIPIDE (sic) Capsule C

RIBAVIRIN Capsule C

RIBAVIRIN Cream A

RIBAVIRIN Solution for injection A

RIBAVIRIN Oral solution A

RIBAVIRIN Ophthalmic ointment A

RIFAMPICIN Capsule or tablet C

RIFAMPICIN Oral suspension C

RIFAMPICIN / ISONIAZID / PYRAZINAMIDE Coated tablet C/C/C

RIFAMPICIN / TRIMETHOPRIM Oral suspension C/C

RIFAMPICIN / TRIMETHOPRIM Coated tablet C/C

RIFAXIMIN ALPHA Topical cream A

RIFAXIMIN ALPHA Oral suspension A

RIFAXIMIN ALPHA Tablet A

RILPIVIRINE Tablet C

RILUZOLE Tablet C

RIMANTADINE Capsule C

RIMANTADINE Oral suspension C

RIMANTADINE Tablet C

RISEDRONATE / CHOLECALCIFEROL Tablet B***/A

RISPERIDONE Oral solution A

Extended-release RISPERIDONE C suspension for injection

RISPERIDONE Tablet C

RISPERIDONE Dispersible tablet C

RITONAVIR Capsule C

RIVASTIGMINE Capsule C

RIVASTIGMINE Patch C*

ROCURONIUM BROMIDE Solution for injection A

ROPINIROLE Tablet C

ROPINIROLE Extended-release tablet C

ROPIVACAINE Solution for injection A

ROSUVASTATIN Tablet C

ROXITHROMYCIN Tablet C

RUFLOXACIN Tablet C

SALBUTAMOL Syrup A

SALBUTAMOL Syrup A

SALBUTAMOL Solution for injection A

SALBUTAMOL Solution for artificial lung A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

SALBUTAMOL Suspension spray C*

SALBUTAMOL Tablet C

SALBUTAMOL / AMBROXOL Syrup A/A

SAQUINAVIR Capsule C

SAQUINAVIR MESYLATE Capsule C

SAQUINAVIR MESYLATE Tablet C

SECNIDAZOLE Oral solution A

SECNIDAZOLE Tablet C

SECNIDAZOLE Tablet C

SELENIUM Solution for injection A

SELENIUM Tablet A

SENNOSIDES A and B Soft gelatin capsule A

SENNOSIDES A AND B / PLUM CONCENTRATED Soft gelatin capsule A/A

SENNOSIDES A-B Oral solution A

SENNOSIDES A-B Tablet A

SENNOSIDES / SODIUM DOCUSATE Tablet A/A

SERTRALINE (SERTRALINE HYDROCHLORIDE) Capsule C

SERTRALINE (SERTRALINE HYDROCHLORIDE) Tablet C

SEVOFLURANE Volatile liquid A

SILDENAFIL Tablet C

SILDENAFIL Chewable tablet C

SILYMARIN Coated tablet C

SIMETHICONE Capsule A

SIMETHICONE Chewable tablet A

SIMETHICONE / TRIMEBUTINE Oral suspension A/B

SIMVASTATIN Tablet C

SIROLIMUS Oral solution A

SIROLIMUS Coated tablet C

SODIUM BICARBONATE / POTASSIUM CHLORIDE Tablet A/A

SODIUM CITRATE AND PHOSPHATE Solution A

SOLIFENACIN Tablet C

HARTMANN’S SOLUTION Solution for injection A

Solution for peritoneal SOLUTION FOR PERITONEAL DIALYSIS A dialysis

SOLUTION FOR HEMODIALYSIS Solution A

BALANCED SALINE SOLUTION Ophthalmic solution A

SOMATOSTIN (sic) Solution for injection A

SUCRALFATE Oral suspension A

SUCRALFATE Tablet A This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

SULBUTIAMINE Tablet A

SULFACETAMIDE Ophthalmic solution A

MICRONIZED SILVER SULFADIAZINE Cream A

SULFAMETHOXAZOLE / TRIMETHOPRIM Dispersible tablet C/C

SULFASALAZINE Tablet B

SULFASALAZINE Film-coated tablet B

SULFASALAZINE Coated tablet B

STREPTOMYCIN SULFATE / PHTHALYLSULFATHIAZOLE Suspension A/A/A/A / PECTIN / KAOLIN

FLUOROMETHOLONE SULFATE / NEOMYCIN Ophthalmic suspension A/A

CRYSTALLINE GLUCOSAMINE SULFATE Powder A

MAGNESIUM SULFATE Powder A

TERBUTALINE SULFATE / GUAIFENESIN Oral solution A/A

FERROUS SULFATE Oral solution A

FERROUS SULFATE Tablet A

SULINDAC Tablet C

SULPIRIDE Capsule C

SULPIRIDE Tablet C

SULTAMICILLIN Oral suspension C

SULTAMICILLIN Tablet C

SUMATRIPTAN Solution for injection A

SUMATRIPTAN Suppository C

SUMATRIPTAN Tablet C

SUMATRIPTAN Effervescent tablet A

SUNITINIB MALATE Capsule C*

SUXAMETHONIUM (SUCCINYLCHOLINE) Solution for injection A

TACALCITOL Ointment A

TACROLIMUS Capsule C

TACROLIMUS Solution for injection A

TACROLIMUS Ointment A

TADALAFIL Tablet C

THALIDOMIDE Tablet C

TAMOXIFEN Tablet C

TAMSULOSIN Capsule C

TAMSULOSIN Extended-release capsule C

BRIMONIDINE TARTRATE / TIMOLOL MALEATE Ophthalmic solution A/A

TAZAROTENE Cream A

TAZAROTENE Ophthalmic gel A

TEGASEROD Tablet C

TEICOPLANIN Solution for injection A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

TELMISARTAN Tablet C

TELMISARTAN / AMLODIPINE Tablet C/C

TELMISARTAN / HYDROCHLOROTHIAZIDE Tablet C/C

TEMOZOLAMIDE (sic) Capsule B***

TENECTEPLASE Solution for injection A

TENOFOVIR Tablet C

TENOFOVIR DISOPROXIL FUMARATE Tablet C

TENOXICAM Solution for injection A

TENOXICAM Tablet C

TENOXICAM Effervescent tablet A

THEOPHYLLINE Extended-release capsule C

THEOPHYLLINE Elixir A

THEOPHYLLINE Extended-release tablet C

TERAZOSIN Tablet C

TERBINAFINE Skin spray A

TERBINAFINE Cream A

TERBINAFINE Gel A

TERBINAFINE Solution A

TERBINAFINE Tablet C

TERBUTALINE Spray powder C*

TERBUTALINE Solution for injection A

TERFENADINE Oral suspension C

TERFENADINE Tablet C

TERIFLUNOMIDE Tablet C

TERLIPRESSIN ACETATE Solution for injection A

TESTOSTERONE Skin gel C

TESTOSTERONE Oily solution for injection C

TESTOSTERONE UNDECANOATE Capsule C

TETRACAINE Ophthalmic solution A

TETRACYCLINE Capsule or tablet C

TETRACYCLINE Solution for injection A

TETRACYCLINE Oral suspension C

TETRAZEPAM Tablet C

TETRYZOLINE Ophthalmic solution A

THIAMAZOLE Tablet C

THIAMPHENICOL Tablet C

THIAMINE Solution for injection A

THIAMINE HYDROCHLORIDE Coated tablet A

TIBOLONE Tablet C This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

TICLOPIDINE Coated tablet C

THIETHYLPERAZINE Solution for injection A

THIETHYLPERAZINE Suppository C

THIETHYLPERAZINE Coated tablet C

TIGECYCLINE Solution for injection A

TIMOLOL Ophthalmic gel A

TIMOLOL Ophthalmic solution A

TINIDAZOLE Oral suspension C

TINIDAZOLE Tablet C

TINIDAZOLE / TIOCONAZOLE Vaginal tablet A/A

THIOPENTAL SODIUM Solution for injection A

THIORIDAZINE Oral suspension C

THIORIDAZINE Coated tablet C

TIOTROPIUM Capsule for inhalation C*

TIPRANAVIR Capsule C

TIPRANAVIR Oral solution A

TIROFIBAN Solution for injection A

THYROXINE / TRIIODOTHYRONINE Tablet C*

TIZANIDINE Tablet C

TOBRAMYCIN Inhalation solution A

TOBRAMYCIN Solution for injection A

TOBRAMYCIN Ophthalmic solution A

TOBRAMYCIN Ophthalmic ointment A

TOLBUTAMIDE Tablet C

TOLCAPONE Coated tablet C

TOLCICLATE Cream A

TOLCICLATE Powder A

TOLCICLATE Skin solution A

TOLNAFTATE Cream A

TOLNAFTATE Solution A

TOLTERODINE Extended-release capsule C

TOLTERODINE Tablet C

TOPIRAMATE Capsule C

TOPIRAMATE Ophthalmic solution A

TOPIRAMATE Tablet C

TOPIRAMATE / PHENTERMINE Extended-release capsule C/C

TOPOTECAN Solution for injection A

SORAFENIB TOSYLATE Tablet C*

BOTULINUM TOXIN TYPE A Solution for injection A

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

TRAMADOL Capsule C

TRAMADOL Solution for injection A

TRAMADOL Oral solution A

TRAMADOL Suppository C

TRAMADOL Extended-release tablet C

TRANDOLAPRIL Capsule C

TRANDOLAPRIL / VERAPAMIL (Coated) tablet C/C

TRAVOPROST Ophthalmic solution A

TRAZODONE Tablet C

TREPROSTINIL Solution for injection A

TRETINOIN Capsule B

TRETINOIN Cream A

TRETINOIN Skin gel A

TRETINOIN Skin solution A

TRIAMCINOLONE Cream A

TRIAMCINOLONE Tablet C

TRIAMCINOLONE ACETONIDE Suspension for injection C

TRIAMCINOLONE / CIPROFLOXACIN Ophthalmic suspension A/A

TRIAZOLAM Tablet C

TRIBENOSIDE Capsule A

TRIFLUOPERAZINE Solution for injection A

TRIFLUOPERAZINE Coated tablet C

TRIFLUSAL Capsule C

TRIHEXYPHENIDYL Tablet C

TRIMEBUTINE Oral suspension B

TRIMEBUTINE Tablet B

TRIMEBUTINE Extended-release tablet B

TRIMEBUTINE MALEATE Solution for injection A

TRIMEBUTINE / SIMETHICONE Capsule B/A

TRIMEBUTINE / SIMETHICONE Tablet B/A

TRIMETAZIDINE Extended-release tablet C

TRIMETHOPRIM / SULFAMETHOXAZOLE Solution for injection A/A

TRIMETHOPRIM / SULFAMETHOXAZOLE Oral suspension C/C

TRIMETHOPRIM / SULFAMETHOXAZOLE Tablet C/C

GLYCERYL TRINITRATE Chewable capsule or tablet C

GLYCERYL TRINITRATE Patch C*

GLYCERYL TRINITRATE Solution for injection A

TRIPTORELIN Suspension for injection C

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

TRITICUM VULGARE / PHENOXYETHANOL Insert A/A

TROLAMINE Topical emulsion A

TROMANTADINE Gel (skin administration) A

TROPISETRON Capsule C

TROPISETRON Solution for injection A

UREA (CARBAMIDE) Cream A

VALACICLOVIR Tablet C

ESTRADIOL VALERATE / TESTOSTERONE ENANTATE Solution for injection A/A

VALGANCICLOVIR Tablet C

MAGNESIUM VALPROATE Capsule C

MAGNESIUM VALPROATE Oral granules for solution A

MAGNESIUM VALPROATE Syrup A

MAGNESIUM VALPROATE Oral solution A

MAGNESIUM VALPROATE Suppository C

MAGNESIUM VALPROATE Oral suspension C

MAGNESIUM VALPROATE Film-coated tablet C

MAGNESIUM VALPROATE Extended-release tablet C

SODIUM VALPROATE Syrup A

SODIUM VALPROATE Oral solution A

SODIUM VALPROATE Coated tablet C

VALPROATE SEMISODIUM Capsule C

VALPROATE SEMISODIUM Film-coated tablet C

VALPROATE SEMISODIUM Extended-release tablet C

VALSARTAN Capsule C

VANCOMYCIN Solution for injection A

VECURONIUM Solution for injection A

VENLAFAXINE Extended-release capsule C

VERALIPRIDE Capsule C

VERAPAMIL Extended-release capsule C

VERAPAMIL Solution for injection A

VERAPAMIL Coated tablet C

VERAPAMIL HYDROCHLORIDE Tablet C

VERAPAMIL HYDROCHLORIDE Extended-release tablet C

VERTEPORFIN Solution for injection A

VIGABATRIN Tablet B***

VINBLASTINE Solution for injection A

VINCAMINE Extended-release capsule C

VINCAMINE Tablet C

VINCRISTINE Solution for injection A

VINORELBINE Capsule C

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

VINORELBINE Solution for injection A

VINPOCETINE Solution for injection C

VITAMIN A Capsule A

VITAMIN A Oral solution A

VITAMIN A AND D Capsule A

VITAMIN A, C AND D Oral solution A

Film-coated tablet or gelatin VITAMIN E A capsule

VORICONAZOLE Solution for injection A

VORICONAZOLE Tablet C

WARFARIN Tablet C

XYLOMETAZOLINE Nasal solution A

IODOCHLOROHYDROXYQUINOLINE / KAOLIN / PECTIN Suspension A/A/A

POVIDONE-IODINE Douche solution A

ZAFIRLUKAST Tablet C

ZALCITABINE Tablet C*

ZANAMIVIR Oral inhalation powder A

ZIDOVUDINE Capsule C

ZIDOVUDINE Solution for injection A

ZIDOVUDINE Oral solution A

ZINC Solution for injection A

ZINC Tablet A

ZINC / PHENYLEPHRINE Ophthalmic solution A/A

ZIPRASIDONE Capsule C

ZIPRASIDONE Solution for injection A

ZIPRASIDONE Oral suspension C

ZOLMITRIPTAN Dispersible tablet C

ZOLPIDEM Tablet C

ZONISAMIDE Capsule C

ZOPICLONE Tablet C

ZUCLOPENTHIXOL Solution for injection A

ZUCLOPENTHIXOL Solution for injection (depot) C

ZUCLOPENTHIXOL Tablet C

A Dissolution or bio-equivalence tests are not required. B Dissolution profile test. It meets the F2 criterion regardless of the dissolved quantity. B*** Dissolution profile test. The dissolution profile test must be conducted at 3 different pH: HCl 0.1N, 4.5 and 6.8. It meets the F2 criterion in three pH, regardless of the dissolved quantity. C Bio-equivalence test.

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected] (Third Section) OFFICIAL GAZETTE Tuesday, September 19, 2017

C* Special test (the guides are available in the General Health Council’s and the Federal Commission for the Protection Against Sanitary Risks’ websites). C** Non-inferiority assay, accompanied by a program of intensive drug safety monitoring. C*** Pharmacodynamic assay carried out in patients. C**** Pharmacodynamic assay carried out in healthy volunteers. NOTES:  In the event that the sponsor decides to carry out the test C instead of the test B or B***, the conclusion of interchangeability will be valid since bio-equivalence (C) is the golden standard.  In special cases, the General Health Council is empowered to define the relevant test. ARTICLE THREE. The tests set forth in this Decision must comply with the criteria and the requirements set out in the relevant Mexican official standards. ARTICLE FOUR. The drug products list herein may be expanded or modified when the General Health Council and the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks, see it fit, whether it is due to a review they carry out or upon the request of any interested party. ARTICLE FIVE. The General Health Council and pursuant to the criteria set forth in article 1 hereof, will add or modify the drug product list contained in this decision and will determine the interchangeability tests for each one of them. PROVISIONAL ARTICLES ONE. This Decision will come into force the following day after it is published in the Federal Official Gazette. TWO. In the case of the drug products included in this list, whose drug substance or active pharmaceutical ingredient is protected by a patent, the provisions of paragraph three of article 167-bis of the Health Supplies Regulation shall apply. THREE. This Decision repeals the similar decisions published in 20 issues of the Federal Official Gazette, dated: February 21 and July 29, 2008; February 23, April 17, August 20 and December 24, 2009; April 13, July 28, September 7 and October 20, 2010; January 17 and August 19, 2011; February 21, 2012; November 20, 2013; July 28 and December 16, 2014; July 13, 2015; February 9 and October 7, 2016; and February 23, 2017, as well as any other provisions that are inconsistent with this decision. Mexico, Mexico City, July 26, 2017.- The General Health Council agreed to publish in the Federal Official Gazette the Decision that determines the type of test to demonstrate the interchangeability of generic drug products and that defines the criteria that are applicable to them.- The Secretary of the Council, Jesús Ancer Rodríguez.- Signature.- The Federal Commissioner for the Protection Against Sanitary Risks, Julio Salvador Sánchez y Tépoz.- Signature.

ANNEX 1 Algorithm to determine the type of interchangeability test

Tuesday, September 19, 2017 OFFICIAL GAZETTE (Third Section)

Drug product

 Non-liposomal parenteral aqueous Criteria: solutions, oral solutions and solutions 1. Dosage form No No Dissolution profile to be inhaled with a nebulizer. 2. Narrow therapeutic range test in lieu of the and critical dose  Gases bio-equivalence  Non-systemic use drug products whose 3. Therapeutic group administration route is ophthalmic, otic, 4. Pharmacokinetics test nasal, oral, topical, rectal and vaginal 5. Physico-chemical and whose absorption does not pose any risks. Yes Do the FEUM, the international Yes pharmacopoeia or the international scientific literature set forth the conditions?

Do the guidelines require a special test? Yes No Yes No

Is the pharmacodynamic approach needed? Or, as defined by the General No Yes Health Council

Is the study being carried out in patients?

Yes No

Note: In special cases, the General Health Council is empowered to define the relevant test.

______

This is a non-official English translation prepared by Servicios Lingüísticos Metáfrasi. For all official purposes, the original Spanish translation, which can be found at www.dof.gob.mx, must be referred to. For information about our translation services, please contact [email protected]